Quality manager jobs in Cary, NC - 223 jobs

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

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)

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: * Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) * Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations * Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions * Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. * Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture * Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise * Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Qualification Here's what you need: * Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. * Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) * Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients * Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area * Prior experience in a Consulting and/or Advisory role * Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Locations

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_****************).

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.

Job DescriptionBenefits: 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 Tacias internal QA/QC systems. The ideal candidate will have a proven track record in federal construction projects and a strong understanding of USACEs 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 drivers 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.

Job Description Job Title Job Reports To (Manager's Title) Quality Control Manager Program Manager Department Job Grade Compensation Operations Status Post date Close date ☐ Exempt ☒ Non-Exempt ☒ Full-Time ☐ Part-Time 10/22/2025 Position Summary: The Quality Control Manager (QCM) will serve as the primary authority for ensuring contract performance objectives, standards, and deliverables are met across all 81st Readiness Division (RD) sites. This position is contingent upon contract award and plays a critical role in maintaining mission readiness, service consistency, and compliance with the contract's Quality Assurance Surveillance Plan (QASP) requirements. The QCM will design, implement, and manage a standardized Quality Control Program that supports all operational areas including Base Operations, Real Property, and Environmental services. Through proactive monitoring, detailed reporting, and root-cause analysis, the QCM will ensure the highest level of quality and customer satisfaction. This position is contingent upon contract award and is for a possible contract. Duties and Responsibilities: Serve as the primary quality authority with full responsibility and accountability for contract compliance, performance standards, and deliverable verification. Direct and maintain a standardized Quality Control (QC) Program across all sites under the 81st RD's area of responsibility. Develop, implement, and continually improve a Quality Control Plan (QCP) consistent with contract requirements and aligned with the government's Quality Assurance Surveillance Plan (QASP) § Employ continuous inspection processes and data-driven trend analysis using mobile Contractor Support System (CSS) checklists and digital dashboards. Conduct quality audits, performance evaluations, and preventive-action reviews to identify systemic issues and implement effective corrective measures. Ensure that inspection findings and trend data are communicated promptly to the Program Manager and government representatives. Facilitate regular QC meetings to evaluate performance results, discuss process improvements, and validate corrective action outcomes. Develop and maintain enterprise-wide quality metrics and performance documentation for reporting to the COR/Stakeholders Collaborate closely with the Program Manager (PM) and Site Safety and Health Officer (SSHO) while maintaining independent oversight per contract requirements. Foster a culture of quality excellence through training, awareness, and accountability across all contract sites. Required Qualifications: The Contractor shall provide a QCM who has full authority and responsibility for assuring performance objectives and standards identified in this contract are met. The QCM must have a minimum of 3 years of satisfactory and relevant experience at a comparable level of responsibility in projects of similar size, scope, and complexity. Must pass a background screen Preferred Qualifications: ISO 9001:2015 Lead Auditor certification (preferred). Bachelor's degree in Quality Assurance, Engineering, Business Administration, or a related technical discipline. Demonstrated experience managing quality programs in DoD, USACE, environments. Strong understanding of FAR 52.246-1 Quality Assurance, inspection protocols, and federal QC documentation standards. Proven ability to employ data-driven methodologies for identifying performance trends and implementing preventive actions. Excellent analytical, communication, and leadership skills, with the ability to drive cross-functional quality initiatives. Proficiency with Contractor Support Systems (CSS), SharePoint, and Microsoft Power BI for QC reporting and analysis. Pay: Negotiable Location: 81st Readiness Division Charlotte, NC Concord, NC Cary, NC Garner, NC McLeansville, NC Winterville, NC High Point, NC Lumberton, NC Morehead City, NC Rocky Mount, NC Salisbury, NC Wilson, NC Winston-Salem, NC Wilmington, NC Knightdale, NC Florence, SC Myrtle Beach, SC Physical and Technical Environment: Prolonged periods of sitting at a desk and working on a computer. · Must be able to lift to 40 pounds at a time. · Must be able to travel to offsite assignments. Benefits: 401(k) Dental insurance Health insurance Life insurance Vision insurance Vacation Time Sick Time (The right is reserved under provisions PL 93-638 Section (b), (f), (g), (i), 20 USD450 Indian Self Determination and Education Assistance Act of 1974 to give PREFERENCE AND OPPORTUNITY for employment, training, and contracts to Indians)

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_****************).

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

**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.

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:

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.

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 cGMP's, 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 Bachelor's 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.

* 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 Qualificationsarrow_right * 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.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

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.