Quality manager jobs in Raleigh, NC - 198 jobs

The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness. Essential Duties and Responsibilities Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards. Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs). Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments. Ensure timely vendor and customer qualification and verification activities. Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations. Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities. Review, approve, and authorize quality-related documents, records, and agreements. Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness. Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement. Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements. Train warehouse operations personnel on quality procedures and compliance expectations. Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices. Conduct annual reviews of SOPs and update processes as required. Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner. Work Experience Qualifications Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry. Results-oriented professional with a strong customer service mindset and effective communication skills. Experience with SAP and electronic QMS platforms preferred. High attention to detail with professional verbal and written communication skills. Ability to manage multiple priorities and projects simultaneously in a regulated environment. Willingness and ability to travel for audits, meetings, and industry events. Strong time management, organizational, and problem-solving skills. Self-motivated, accountable, and proactive in driving quality initiatives. Proficient in administrative tools, including MS Office and Google Workspace. Excellent written, verbal, and interpersonal communication skills. Masters is preferred.

This position for Quality Management Systems (QMS) will ensure compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards in a warehouse environment specializing in clinical trial supplies. This role involves implementing, monitoring, and enhancing quality systems to maintain regulatory compliance and ensure operational excellence. Essential Duties and Responsibilities: Manage and oversee the QMS processes, including documentation, control, and implementation of policies and procedures in compliance with GDP, 21 CFR, and industry standards. Conduct routine internal & external audits of warehouse operations to ensure adherence to quality guidelines, regulatory requirements, and standard operating procedures (SOPs). Coordinate and manage deviation investigations, CAPA (Corrective and Preventive Actions), change control processes and Risk Assessments. Ensure Vendor/Customer Verification & Qualification on timely basis also should do audit if required on site of partners site. Accurate documentation check for the each transaction been carried out for the inbound and outbound by the operation team. Ensure accuracy and effective maintenance of the eQMS portal for all quality-related documentation and activities. Reviewing and Authorizing Quality related documents and agreements. Prepare and review quality documentation such as SOPs using eQMS portal, validation protocols, and training records to ensure they meet regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing necessary documentation and ensuring compliance readiness. Monitor and evaluate the effectiveness of QMS processes through metrics and reporting, identifying areas for improvement. Conduct training sessions for staff on QMS policies, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory affairs, to address quality-related issues and implement improvements. Training the operation team personnel in warehouse. Stay updated on evolving regulatory requirements and incorporate changes into QMS practices. Yearly review on the SOPs if any changes need to be made and upgrade the processes. All documents record should be kept in controlled and secured manner. Work Experience Qualifications: Proven 5+ years of work experience in QMS role within the Pharmaceutical Industry. Result driven orientation having solid customer service attitude with excellent negotiation skills. Previous experience in SAP & MS Office will be an added advantage Must have keen attention to detail and possess proper phone and email etiquette. Ability to stay organized while effectively prioritizing multiple projects at once. High attention to detail when completing projects. Person should be in position to travel for meetings and exhibitions and events. Strong time management skills to complete projects by deadlines. Self-motivated individual who takes ownership of their projects. Administrative skills (MS Office and Google Workspace are required). Maintain excellent verbal, writing, and language skills.

Job DescriptionSalary: The Quality Assurance Operations Manager supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports). PRIMARY DUTIES AND RESPONSIBILITIES Provide direct oversight to QA operations staff. Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews. Review, approve Laboratory test data and reports. Prepare and approve certificates of Analysis. Support activities related to internal and external audits. Represent site Quality group during Client and regulatory audits. Collaborate with Laboratory management to support company goals. Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner. Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness. Actively participate in operational excellence programs/initiatives. Review laboratory protocols and reports for accuracy and compliance to cGMPs, as applicable. Site system owner for OOS, complaint, and deviation programs. Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation. Completes required actions for identified corrective/preventive actions for the Quality department. REQUIREMENTS & QUALIFICATIONS Qualification include a Bachelors degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development. DESIRED SKILLS Enthusiastic, team player, collaborative across all departments to achieve the common goals. Ability to focus on internal processes while maintaining focus on client needs. Ability to work in a fast paced, dynamic environment. Experience with LEAN implementation. Familiarity with laboratory information management systems. ISO 17025 or 9001 experience and knowledge. Demonstrated ability to foster a Quality Culture across the organization. Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: + Product Quality Complaints + Corrective and Preventive Actions (CAPA) + Deviations + Management Reporting and Trending + Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. + Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. + Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. + Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. + Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. + Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. **Qualifications** Required **Required Qualifications:** + Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. + Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. + Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). + Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. + Strong analytical and problem-solving skills with a data-driven mindset. + Excellent communication, leadership, and stakeholder management skills. + Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. + Ability to travel internationally as needed. Preferred + Basic understanding of artificial intelligence and advanced analytics + Experience supporting risk management programs or frameworks. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Join the Leader in Trading Card Manufacturing At Millennium Print Group (MPG), a proud subsidiary of The Pokémon Company International, we're on a mission to be the world's leading manufacturer of trading card games and collectibles. Based in North Carolina's vibrant Research Triangle Park and Piedmont Triad regions, we're at the heart of innovation in this fast-growing industry. Since our founding in 2014, our dedicated team has built a world-class operation known for exceptional quality, customer focus, and market agility. Specializing in trading and collectible cards, we offer a unique range of services that set us apart. Our commitment to excellence has fueled rapid growth - we've nearly tripled in size since 2019 - and we're just getting started. Come be part of a forward-thinking, high-performing team that's shaping the future of collectible printing. At MPG, your work makes an impact. Click here to review our Privacy Notice for applicants. Click here to review our applicant Privacy Notice for SMS Texting and Terms of Service. Director of Quality Join Millennium Print Group as our Director of Quality! We are seeking an experienced Director of Quality to lead enterprise-wide quality strategy, ISO 9001 compliance, and continuous improvement across a fast-paced manufacturing environment. This senior leadership role partners closely with executive leadership to ensure product excellence, regulatory compliance, and customer satisfaction. Location: Raleigh, NC Schedule: Full-Time | Onsite Pay & Benefits: Director-level compensation + bonus eligibility + comprehensive benefits package What You'll Do: Lead company-wide quality strategy, QMS, and ISO 9001 certification efforts Oversee QA and QMS teams responsible for inspections, audits, CAPA, and training Establish quality standards, KPIs, and metrics for defect reduction and process optimization Drive root cause analysis, corrective actions, and continuous improvement initiatives Partner with customers, suppliers, and regulators on quality matters Ensure compliance with ISO, ANSI, OSHA, and customer requirements What You'll Bring: Bachelor's degree in quality, Engineering, or related field 10+ years of quality leadership experience in manufacturing, print, or packaging environments. Proven success leading ISO 9001 systems and audit programs ASQ certifications preferred (CQE, CMQ/OE, CSSBB, CQA) Expertise in Lean, Six Sigma, CAPA, SPC, FMEA, and data-driven quality improvement Strong leadership, communication, and strategic planning skills How You Will Be Successful: Dedicated to Quality and Safety: Setting and Executing Quality Strategy Through the Leadership of High-Performing Quality Teams Challenging the Expected: Lead transformation through continuous improvement and innovation Building Relationships: Collaborate with customers, suppliers, and cross-functional teams Integrity and Respect: Maintain compliance, transparency, and accountability Why Join MPG? Millennium Print Group, a subsidiary of The Pokémon Company International, is the largest trading card printer in the world. We offer competitive compensation, leadership impact, and the opportunity to shape quality standards behind globally recognized brands. Apply today and lead the future of quality at MPG. #MillAll What to Expect MPG offers a leading-edge compensation package which includes the following: A highly competitive compensation "above the industry" commensurate with experience which includes an annual incentive bonus plan 100% Employer-paid medical, dental base plan, vision, life/AD&D, and short-term and long-term disability, while subsidizing premiums for medical, dental, and vision for employee dependents 401(k) Plan with up to a 6% (dollar for dollar) Employer match Health Savings/Flexible Spending Account options Paid time off, including 10 company-paid holidays, plus 1 floating holiday Employee Assistance Program Comprehensive relocation package available for qualified candidates And, much more! Millennium Print Group is an Equal Opportunity Employer The duties and responsibilities described above are essential functions of the job. The following qualifications are representative of the knowledge, skills, and or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Working at Freudenberg: We will wow your world! Responsibilities: Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications. Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision. Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration. Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions. Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations Qualifications: Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience 5+ years experience in a quality leadership or management role Proven experience implementing and maintaining an ISO 9001 compliant QMS Experience managing quality control in a manufacturing environment or testing laboratory The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Performance Materials LP (USA)

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities Acts as a key advocate for quality excellence across all levels of the organization Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network Actively participates in cross-functional initiatives to align global quality strategies Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities Performs other duties, as assigned Minimum Requirements: • Bachelor's degree in engineering, life sciences with 13+ years of related experience OR • Master's degree in engineering, life sciences with 11+ years of related experience OR • Ph.D. in engineering, life sciences with 9+ years of related experience • 10+ years of people management, leadership, and team management experience • Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility. • Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. • Experience collaborating and interacting with a global team. • Training and/or familiarity with Quality Risk Management principles Preferred Requirements: • 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering) • Strong track record of driving operational excellence • Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Responsive recruiter Benefits: Competitive salary Dental insurance Free uniforms Health insurance Paid time off Vision insurance 401(k) matching Bonus based on performance Company car Position: Quality Control Manager Description: Cooper Tacia General Contracting is seeking an experienced and highly motivated Quality Control (QC) Manager to oversee quality management for our Federal Projects, in compliance with the U.S. Army Corps of Engineers (USACE) standards and specifications. This role is critical to ensure that all construction activities meet contract requirements, safety protocols, and quality benchmarks mandated by USACE and Cooper Tacia's internal QA/QC systems. The ideal candidate will have a proven track record in federal construction projects and a strong understanding of USACE's Three-Phase QC System. Responsibilities: · Implement and manage the project-specific QA/QC Plan in full compliance with USACE EM 385-1-1 and the Three-Phase Quality Control System, ensuring strict adherence to contract documents and quality standards. · Act as the primary liaison with USACE, overseeing all correspondence, inspections, and quality documentation, including Daily QC Reports, submittals, RFIs, and Definable Features of Work (DFOW) tracking. · Plan, coordinate, and lead Preparatory, Initial, and Follow-Up QC meetings with subcontractors and field personnel to ensure readiness, approved materials, and clear quality expectations. · Conduct and document field inspections and third-party testing, analyze results, and manage corrective actions for non-compliant work, including verification of all reworks prior to progression. · Collaborate with the project team to proactively resolve design conflicts and material compliance issues, ensuring quality and constructability align with project goals and schedules. · Maintain and update all QA/QC records, including punch lists, non-conformance reports (NCRs), and corrective action logs, supporting smooth project turnover and closeout documentation. · Promote a culture of quality by integrating Lean construction methods, enforcing QA/QC and safety alignment, and driving continuous improvement in field and office operations. Requirements:· Minimum of 2-5 years of overall construction experience, in a dedicated QA/QC role preferably on U.S. Army Corps of Engineers (USACE) or other federal projects.· Current USACE Construction Quality Management (CQM) for Contractors certification (must be maintained throughout project duration). · Strong knowledge of EM 385-1-1, Unified Facilities Guide Specifications (UFGS), and the Three-Phase QC System, with proven ability to implement them in the field. · Proficiency in construction management software, including Procore, Microsoft Office, and familiarity with RMS/QCS systems preferred. · Exceptional organizational, documentation, and communication skills, with the ability to manage multiple QA/QC workflows and coordinate across teams. · Must be a U.S. citizen and able to pass a background check for base access; valid driver's license required. Employment Type: Full Time Salary: $85,000-$120,000 Benefits: · 100% Employer Paid Health, Vision & Dental Insurance for employee.· PTO/ Paid Holidays· 401K W/ 3% Match · Continued Education as needed.· Company Vehicle with Fuel Card.· Annual Performance bonus Application Process: All interested individuals must submit a resume and three references. Email to: ******************************* We are an equal opportunity and drug-free workplace. Pre-employment drug screening required. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of responsibilities, duties and skills required. Personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Compensation: $85,000.00 - $120,000.00 per year We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Join the Cooper Tacia General Contracting Company Team At Cooper Tacia General Contracting Company, we believe in building excellence from the ground up. Our story began in 1996 with John Cooper and Chris Tacia, two high school students who transformed a firewood business into a leading construction company. Today, we deliver top-quality projects across the southeast United States. Why Work with Us? We value innovation, collaboration, and professional growth. Here's why you should consider a career with Cooper Tacia: Diverse Projects: Work on a wide range of projects, including manufacturing facilities, office buildings, government and education facilities, restaurant and retail spaces, apartment complexes, and water treatment plant upgrades. Career Development: We are committed to your growth, offering opportunities for continuous learning and advancement. Supportive Environment: Join a team of dedicated professionals who are passionate about what they do. Excellence in Every Project: Contribute to high-quality projects that make a real impact. Competitive Benefits and Compensation: Enjoy a comprehensive benefits package, including health insurance, retirement plans, paid time off, and competitive salaries. We pay 100% of employee benefits for the employee only, offer a 401(k) with a 3% match, 10 days of PTO, and paid holidays. Explore Career OpportunitiesWe are always on the lookout for talented individuals to join our team. Whether you're an experienced professional or just starting your career, we have opportunities that can help you grow and succeed.

The Associate Quality Assurance Manager supports The Upper Deck Company's business units by assisting in the oversight of the Shipping and Quality Assurance departments. This position is ideal for a motivated, detail-oriented professional with strong organizational skills, leadership potential, and experience using project management and data analytics tools to improve workflow and performance. Working closely with the Quality Assurance Manager, this role helps ensure that every product meets Upper Deck's high standards for quality and accuracy while supporting the continued growth and development of team members. ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned Support the daily operations of the Shipping and QA departments, maintaining focus on accuracy, efficiency, and on-time project completion. Supervise QA and Shipping team members, providing coaching, feedback, and assistance with problem-solving. Use project management software (e.g., Asana, Monday, Smartsheet) to organize priorities, track progress, and communicate updates. Generate and interpret data reports and quality metrics to identify areas for improvement, reduce errors, and support decision-making. Collaborate with Project Coordinators, Talent Relations, and Brand Management teams to resolve discrepancies and maintain alignment across departments Support continuous improvement initiatives and standard operating procedure (SOP) development. Take initiative in identifying process improvements and helping implement new tools or methods that enhance quality and efficiency. INTERACTION This position will interact closely with the Quality Assurance Manager, Talent Relations, Project Managers, Project Coordinators. SUPERVISORY RESPONSIBILITIES Supervisory responsibilities for Boxing, QA, Shipping Clerks. EDUCATION/YEARS EXPERIENCE Bachelor's degree in business management, Operations, or a related field, or equivalent work experience. 3-5 years of experience in project coordination, operations, or quality assurance. Demonstrated success in managing teams and improving performance through data analytics and technology-based solutions. Experience using project management software and working with data reporting tools. REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. KNOWLEDGE, SKILLS AND ABILITIES Proficient in project management software (e.g., Asana, Monday, Smartsheet) and data visualization tools (e.g., Excel, Power BI, Tableau). Strong analytical, problem-solving, and troubleshooting abilities with a data-focused mindset. Excellent communication and interpersonal skills for cross-departmental collaboration. Highly organized with the ability to manage multiple high-priority initiatives simultaneously. Self-motivated leader with a hands-on approach and professional demeanor. Strong commitment to quality, accuracy, and continuous improvement.

Job Description - The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and external clients Essential Functions Author or act as author for lab investigations, deviations, protocols and specifications for raw materials. Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines. Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks. Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements Interact with third party laboratories for microbial and analytical testing of raw materials Generate and/or review shipping paperwork for third part testing and prepare samples for shipment. Create purchase requisitions for lab supplies and third-party testing Perform weekly laboratory audit inspections Perform sampling of raw materials as needed Review third party laboratory investigations and protocols. Provide technical support to the laboratory for method and instrument troubleshooting as needed. Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques. May perform testing of raw materials, packaging components, and other samples as needed. Other duties as assigned Supervisory responsibilities : Direct Reports: Yes Indirect Reports: None Key Relationships: Manufacturing Operations Quality Assurance Analytical R&D Program Management Travel requirements : None Education and Experience Minimum BA or BS in a scientific discipline required Minimum of 5 years of prior supervisory experience. Minimum 5-7 years in an Analytical development or Quality Control setting for Pharmaceutical Products or Raw Materials preferred Experience establishing and maintaining relationships with key decision makers Knowledge, Skills, and Abilities Knowledge of cGMPs Good communication, organization and computer skills are required. Knowledge of Empower required; LIMS and Microsoft Office programs knowledge is desired. Ability and willingness to work additional hours as required by business need At least 5 years' experience in a CRO environment Experience with USP, EP and JP monographs. Experience with laboratory equipment such as HPLC (UV, Ion detectors, RI detectors), GC (Headspace, FID, TCD), FTIR, Auto Titrators, Karl Fischer Titrators (Volumetric and Coulometric), and Particle size. Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders Excellent verbal and written communication skills Ability to work with minimal supervision Experience in Data Review of Analytical data per GDP guidelines. Proven ability to review and evaluate the compliance and completeness of analytical data. Able to multi-task productively, applying time management processes and procedures effectively. Works toward common goals by supporting, encouraging, and sharing information with colleagues. Strong analytical skills and ability to understand business and financial implications of contracts Self-directed Physical Demands and Work Environment While performing the duties of this job, there may be certain physical demands required for the position. Requires frequent sitting and walking Requires carrying under 20 LBS, occasionally 20 - 60 LBS Requires pushing, & pulling under 20 LBS, occasionally 20-60 LBS Requires occasional bending, twisting, reaching, & gripping Requires constant seeing & hearing Other Duties You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked. Powered by JazzHR PSMq2DXBY7

**Country:** United States of America ** Onsite **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of "U.S. Person" go here. ********************************************************************************************** **Security Clearance:** None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. **What You Will Do:** + Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. + Performs escape management procedures for disclosure of nonconforming hardware + Leads customer audits/assessments as required + Manages customer satisfaction metrics and develops plans to recover and maintain goals + Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts + Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) **Qualifications You Must Have:** + Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience **or** an Advanced Degree in a related field + In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. + Experienced and comfortable with customer-facing responsibilities **Qualifications You Must Have:** + 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. + FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. + Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) **What We Offer:** _Some of our competitive benefits package includes: _ + Medical, dental, and vision insurance + Three weeks of vacation for newly hired employees + Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option + Tuition reimbursement program + Student Loan Repayment Program + Life insurance and disability coverage + Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection + Birth, adoption, parental leave benefits + Ovia Health, fertility, and family planning + Adoption Assistance + Autism Benefit + Employee Assistance Plan, including up to 10 free counseling sessions + Healthy You Incentives, wellness rewards program + Doctor on Demand, virtual doctor visits + Bright Horizons, child and elder care services + Teladoc Medical Experts, second opinion program + This position may be eligible for relocation + And more! **Learn More and Apply Now!** Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our **Avionics** team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. **WE ARE REDEFINING AEROSPACE.** * Please consider the following role type definitions as you apply for this role. **Onsite:** Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. _Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings._ At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. **_As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote._** The salary range for this role is 107,500 USD - 204,500 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of “U.S. Person” go here. ********************************************************************************************** Security Clearance: None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. What You Will Do: Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. Performs escape management procedures for disclosure of nonconforming hardware Leads customer audits/assessments as required Manages customer satisfaction metrics and develops plans to recover and maintain goals Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) Qualifications You Must Have: Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience or an Advanced Degree in a related field In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. Experienced and comfortable with customer-facing responsibilities Qualifications You Must Have: 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) What We Offer: Some of our competitive benefits package includes: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option Tuition reimbursement program Student Loan Repayment Program Life insurance and disability coverage Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection Birth, adoption, parental leave benefits Ovia Health, fertility, and family planning Adoption Assistance Autism Benefit Employee Assistance Plan, including up to 10 free counseling sessions Healthy You Incentives, wellness rewards program Doctor on Demand, virtual doctor visits Bright Horizons, child and elder care services Teladoc Medical Experts, second opinion program This position may be eligible for relocation And more! Learn More and Apply Now! Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our Avionics team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. WE ARE REDEFINING AEROSPACE. * Please consider the following role type definitions as you apply for this role. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings. At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 107,500 USD - 204,500 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. Key Responsibilities: · Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. · Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting. · Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators. · Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation. · Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies. · Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations. · Responsible for the site's Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site. · Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees. · Manage the resolution of unexpected complex compliance or quality system issues as they arise · Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates. · Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required. · Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset. · Support the development of the Quality department budget in line with routine business planning cycles. · 10% travel expected (domestic or international). Qualifications Required: · Bachelor's degree in a scientific or engineering discipline. · Minimum of 6 years of experience working within the biological and/or pharmaceutical industry. · Experience in a Quality leadership role. · Analytical equipment qualification experience. · Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination. · Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. Preferred: · Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.). · Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor). · An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. · Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels. · Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs. · Proven ability to manage multiple priorities and work independently with minimal supervision. · Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. · Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. · Ability to build and nurture strong and positive relationships. · The ability to work in a team environment and interact with all levels of the organization. · Results-driven leader who commits to stretch goals and delivers results. Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs. If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Lab Services Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are currently seeking a Quality Control Lab Services Manager, to join the Quality Team for the new Johnson & Johnson Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. The QC Lab Services Manager is responsible for leading the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. Key Responsibilities: · Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others. · Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting. · Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators. · Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation. · Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies. · Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations. · Responsible for the site's Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site. · Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees. · Manage the resolution of unexpected complex compliance or quality system issues as they arise · Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates. · Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required. · Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset. · Support the development of the Quality department budget in line with routine business planning cycles. · 10% travel expected (domestic or international). Qualifications Required: · Bachelor's degree in a scientific or engineering discipline. · Minimum of 6 years of experience working within the biological and/or pharmaceutical industry. · Experience in a Quality leadership role. · Analytical equipment qualification experience. · Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination. · Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment. · Experience interacting with health authorities and taking a leading role in regulatory inspections and audits. Preferred: · Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.). · Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor). · An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements. · Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels. · Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs. · Proven ability to manage multiple priorities and work independently with minimal supervision. · Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements. · Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment. · Ability to build and nurture strong and positive relationships. · The ability to work in a team environment and interact with all levels of the organization. · Results-driven leader who commits to stretch goals and delivers results. Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs. If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Lab Services Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

WHAT MAKES US EPIC? At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating. Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development. QUALITY ASSURANCE What We Do The Quality Assurance team owns the testing process, risk management, and quality evaluation of all products and functions across Epic. Our team works closely with developers and production to ensure the best possible user experience for our community and customers. What You'll Do We're looking for an experienced QA Manager for our Online team! In this role, you will be a leader in developing a quality strategy. You will be guiding quality for our Distribution team, partnering with other discipline leads, and innovating and improving our quality processes. If you are passionate about leading and mentoring experienced QA professionals in an exciting, fast-paced environment, we'd love to talk to you! In this role, you will Lead, manage, and mentor a diverse QA organization within the Distro team, including functional testers and external partners, QA analysts, engineers, and SDETs. Support growth across all QA disciplines while effectively managing and mentoring senior QA SMEs with deep domain and technical expertise. Own the Distro Quality Strategy and quality signals, accounting for staffing constraints, backend services, and distributable applications. Ensure QA engagement throughout the full development and release lifecycle while using KPIs, metrics, and qualitative signals to assess product quality, testing effectiveness, and release risk, and to drive continuous improvement. Drive prioritization and execution in a dynamic operating model, where QA supports testing, release validation, and live support. Balance competing priorities, unplanned work, and external requests to prevent QA from becoming a bottleneck while maintaining appropriate quality standards in a low-risk-tolerance environment Guide release readiness and provide cross-pod oversight, collaborating closely with engineering, product, and stakeholder teams to determine test scope, release timing, and acceptable risk. Collaborate with QA leadership across Epic to identify cross-product risks, dependencies, and mitigation strategies. Communicate clearly and effectively across teams and stakeholders, explaining priority shifts, risk trade-offs, and release decisions to QA teams, partner teams, and leadership. Remain technically capable and hands-on when required, stepping in to support testing or releases during coverage gaps, and maintaining sufficient technical depth to engage credibly with QA engineers and developers What we're looking for Proven senior experience leading QA teams with mixed skill sets and seniority, including technical and non-technical contributors, external partners, and senior QA SMEs. Demonstrated ability to mentor experienced ICs while providing clear direction and accountability Proven strong understanding of testing and releasing both backend services and distributable applications, including APIs, services, and client-facing software, with an appreciation for the differing risks and validation strategies involved Exceptional prioritization and operational judgment, particularly in understaffed, fast-paced environments with multiple stakeholders and low tolerance for risk Experience supporting release management activities, making informed decisions around test scope, release readiness, and risk acceptance, and setting clear expectations with internal and cross-team stakeholders Solid technical foundation in modern QA practices, including test automation, CI/CD integration, testability, and quality metrics, with the ability to contribute directly when needed Strong communication skills, able to clearly explain priority shifts, risks, and trade-offs to QA teams, partner teams, and leadership Expert-level use of quality metrics and KPIs to guide prioritization, forecast risk, and drive continuous improvement across products, processes, and teams EPIC JOB + EPIC BENEFITS = EPIC LIFE Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical. ABOUT US Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent. Like what you hear? Come be a part of something Epic! Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here. Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager, Quality Control Microbiology What you will do Let's do this. Let's change the world. In this vital role, you will manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring, clean utilities' monitoring, and routine microbiological testing to support drug substance manufacturing. The Manager, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing, and production in-process and final drug substance testing. Manage the training program for sampling and testing team. Assist with planning, scheduling, and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes. Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling, coordinating activities with manufacturing operations, reviewing and interpreting data, and writing trend reports. Act as Subject Matter Expert for method families and testing platforms used in the microbiology department. Work cross-functionally with Manufacturing, Analytical Sciences, Facilities & Engineering, and Quality teams to align processes with business needs. Author, revise, and review documents and reports including but not limited to: SOPs, safety assessments, trend reports, qualification/validation summary reports, microorganism assessments, and technical reports. Represent the microbiology department during agency inspections and internal audits. Work closely with the global Quality Control organization to drive standardization of testing processes and procedures. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Lead process improvement projects that may be local or global in scope. Support routine activities over the weekends and public holidays as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager Quality Control Microbiology we seek is a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate's degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor's degree and 5 years of Quality or Aseptic Manufacturing experience OR Master's degree and 3 years of Quality or Aseptic Manufacturing experience OR Doctorate degree And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Strong leadership skills, with the ability to manage multiple direct reports. Degree in Microbiology, Biology, Biochemistry, or related scientific field. Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data. Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC. Experience with equipment validation. Solid understanding of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 122,421.00 USD - 142,851.00 USD

The Quality Systems Specialist is responsible for supporting the Quality Management System (QMS), including GxP document management and training programs. This role ensures compliance with regulatory standards, maintains the integrity of documentation systems, and collaborates with cross-functional teams to support document and training needs. Essential Duties GxP Document Management Collaborate cross-functionally to generate workflow status reports and support document owners with new document creation and revisions. Review procedural documents for compliance with formatting, metadata, and applicable standards. Initiate periodic review workflows. Serve as workflow owner as needed. Assist document owners in ensuring proper GxP records management. Create document reports to support business processes, including periodic review and stagnant draft reports. Generate document owner, workflow owner, and task owner reports to support offboarding activities and transfer ownership as appropriate. Training Program Support Generate training reports and distribute upcoming and overdue training notifications. Initiate training assessment forms for managers of new personnel. Create learner roles, training requirements, and curricula within the training management system. Quality Management System Support Schedule and facilitate initial and status meetings. Route forms for electronic signature and maintain tracking logs. Upload completed forms into the document management system. Audits and Inspections Prepare for and participate in internal and external audits related to document control and quality systems. Skills & Education Requirements Bachelor's degree in Life Sciences or a related field, or an Associate degree with relevant work experience. Minimum of 5 years of document control experience. Proficiency with electronic document management systems (e.g., Veeva QualityDocs). Experience supporting gene and cell therapy products. Prior experience in a startup or fast-paced environment. Demonstrated integrity, accountability, and strong teamwork skills.