The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness.
Essential Duties and Responsibilities
Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards.
Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs).
Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments.
Ensure timely vendor and customer qualification and verification activities.
Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations.
Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities.
Review, approve, and authorize quality-related documents, records, and agreements.
Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards.
Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness.
Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement.
Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance.
Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements.
Train warehouse operations personnel on quality procedures and compliance expectations.
Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices.
Conduct annual reviews of SOPs and update processes as required.
Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner.
Work Experience Qualifications
Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry.
Results-oriented professional with a strong customer service mindset and effective communication skills.
Experience with SAP and electronic QMS platforms preferred.
High attention to detail with professional verbal and written communication skills.
Ability to manage multiple priorities and projects simultaneously in a regulated environment.
Willingness and ability to travel for audits, meetings, and industry events.
Strong time management, organizational, and problem-solving skills.
Self-motivated, accountable, and proactive in driving quality initiatives.
Proficient in administrative tools, including MS Office and Google Workspace.
Excellent written, verbal, and interpersonal communication skills.
Masters is preferred.
$67k-105k yearly est. 4d ago
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Quality Manager
Freudenberg Medical 4.3
Quality manager job in Durham, NC
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)
$72k-107k yearly est. Auto-Apply 40d ago
Quality Assurance Operations Manager
Boston Analytical 4.2
Quality manager job in Morrisville, NC
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.
$73k-105k yearly est. 20d ago
Director, Clinical Quality Assurance
Eisai Us 4.8
Quality manager job in Durham, NC
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
$94k-136k yearly est. Auto-Apply 60d+ ago
Director, Parenteral Sterility Assurance
Eli Lilly and Company 4.6
Quality manager job in Raleigh, NC
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
$133.5k-220k yearly Auto-Apply 60d+ ago
Associate Quality Assurance Manager
The Upper Deck Company, LLC 3.9
Quality manager job in Durham, NC
The Associate Quality Assurance Manager supports The Upper Deck Company's business units by assisting in the oversight of the Shipping and Quality Assurance departments. This position is ideal for a motivated, detail-oriented professional with strong organizational skills, leadership potential, and experience using project management and data analytics tools to improve workflow and performance. Working closely with the Quality Assurance Manager, this role helps ensure that every product meets Upper Deck's high standards for quality and accuracy while supporting the continued growth and development of team members.
ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned
* Support the daily operations of the Shipping and QA departments, maintaining focus on accuracy, efficiency, and on-time project completion.
* Supervise QA and Shipping team members, providing coaching, feedback, and assistance with problem-solving.
* Use project management software (e.g., Asana, Monday, Smartsheet) to organize priorities, track progress, and communicate updates.
* Generate and interpret data reports and quality metrics to identify areas for improvement, reduce errors, and support decision-making.
* Collaborate with Project Coordinators, Talent Relations, and Brand Management teams to resolve discrepancies and maintain alignment across departments Support continuous improvement initiatives and standard operating procedure (SOP) development.
* Take initiative in identifying process improvements and helping implement new tools or methods that enhance quality and efficiency.
INTERACTION
This position will interact closely with the Quality Assurance Manager, Talent Relations, Project Managers, Project Coordinators.
SUPERVISORY RESPONSIBILITIES
Supervisory responsibilities for Boxing, QA, Shipping Clerks.
EDUCATION/YEARS EXPERIENCE
* Bachelor's degree in business management, Operations, or a related field, or equivalent work experience.
* 3-5 years of experience in project coordination, operations, or quality assurance.
* Demonstrated success in managing teams and improving performance through data analytics and technology-based solutions.
* Experience using project management software and working with data reporting tools.
REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
KNOWLEDGE, SKILLS AND ABILITIES
* Proficient in project management software (e.g., Asana, Monday, Smartsheet) and data visualization tools (e.g., Excel, Power BI, Tableau).
* Strong analytical, problem-solving, and troubleshooting abilities with a data-focused mindset.
* Excellent communication and interpersonal skills for cross-departmental collaboration.
* Highly organized with the ability to manage multiple high-priority initiatives simultaneously.
* Self-motivated leader with a hands-on approach and professional demeanor.
* Strong commitment to quality, accuracy, and continuous improvement.
$110k-141k yearly est. 42d ago
Director of Quality
MPG 4.8
Quality manager job in Raleigh, NC
Join the Leader in Trading Card Manufacturing
At Millennium Print Group (MPG), a proud subsidiary of The Pokémon Company International, we're on a mission to be the world's leading manufacturer of trading card games and collectibles. Based in North Carolina's vibrant Research Triangle Park and Piedmont Triad regions, we're at the heart of innovation in this fast-growing industry.
Since our founding in 2014, our dedicated team has built a world-class operation known for exceptional quality, customer focus, and market agility. Specializing in trading and collectible cards, we offer a unique range of services that set us apart.
Our commitment to excellence has fueled rapid growth - we've nearly tripled in size since 2019 - and we're just getting started.
Come be part of a forward-thinking, high-performing team that's shaping the future of collectible printing. At MPG, your work makes an impact.
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Director of Quality
Join Millennium Print Group as our Director of Quality!
We are seeking an experienced Director of Quality to lead enterprise-wide quality strategy, ISO 9001 compliance, and continuous improvement across a fast-paced manufacturing environment. This senior leadership role partners closely with executive leadership to ensure product excellence, regulatory compliance, and customer satisfaction.
Location: Raleigh, NC
Schedule: Full-Time | Onsite
Pay & Benefits: Director-level compensation + bonus eligibility + comprehensive benefits package
What You'll Do:
Lead company-wide quality strategy, QMS, and ISO 9001 certification efforts
Oversee QA and QMS teams responsible for inspections, audits, CAPA, and training
Establish quality standards, KPIs, and metrics for defect reduction and process optimization
Drive root cause analysis, corrective actions, and continuous improvement initiatives
Partner with customers, suppliers, and regulators on quality matters
Ensure compliance with ISO, ANSI, OSHA, and customer requirements
What You'll Bring:
Bachelor's degree in quality, Engineering, or related field
10+ years of quality leadership experience in manufacturing, print, or packaging environments.
Proven success leading ISO 9001 systems and audit programs
ASQ certifications preferred (CQE, CMQ/OE, CSSBB, CQA)
Expertise in Lean, Six Sigma, CAPA, SPC, FMEA, and data-driven quality improvement
Strong leadership, communication, and strategic planning skills
How You Will Be Successful:
Dedicated to Quality and Safety: Setting and Executing Quality Strategy Through the Leadership of High-Performing Quality Teams
Challenging the Expected: Lead transformation through continuous improvement and innovation
Building Relationships: Collaborate with customers, suppliers, and cross-functional teams
Integrity and Respect: Maintain compliance, transparency, and accountability
Why Join MPG?
Millennium Print Group, a subsidiary of The Pokémon Company International, is the largest trading card printer in the world. We offer competitive compensation, leadership impact, and the opportunity to shape quality standards behind globally recognized brands.
Apply today and lead the future of quality at MPG.
#MillAll
What to Expect
MPG offers a leading-edge compensation package which includes the following:
A highly competitive compensation "above the industry" commensurate with experience which includes an annual incentive bonus plan
100% Employer-paid medical, dental base plan, vision, life/AD&D, and short-term and long-term disability, while subsidizing premiums for medical, dental, and vision for employee dependents
401(k) Plan with up to a 6% (dollar for dollar) Employer match
Health Savings/Flexible Spending Account options
Paid time off, including 10 company-paid holidays, plus 1 floating holiday
Employee Assistance Program
Comprehensive relocation package available for qualified candidates
And, much more!
Millennium Print Group is an Equal Opportunity Employer
The duties and responsibilities described above are essential functions of the job. The following qualifications are representative of the knowledge, skills, and or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
$105k-148k yearly est. Auto-Apply 17d ago
Director, QA Drug Substance Operations
Job Listingsfujifilm
Quality manager job in Holly Springs, NC
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_****************).
$89k-136k yearly est. Auto-Apply 32d ago
SAP Quality Management/Manufacturing Manager - Chemicals Industry
Accenture 4.7
Quality manager job in Raleigh, NC
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
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
Requesting an Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement (********************************************************************************************************************************************
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
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$100.5k-270.3k yearly 56d ago
Manager Quality Control
Endo 4.7
Quality manager job in Raleigh, NC
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.
$82k-113k yearly est. Auto-Apply 34d ago
Director, QA Drug Substance Operations
Fujifilm Diosynth Biotechnologies 4.0
Quality manager job in Holly Springs, NC
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_****************).
$114k-141k yearly est. Auto-Apply 39d ago
Quality Control Manager
Cooper Tacia General Contracting Company
Quality manager job in Raleigh, NC
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.
$85k-120k yearly Auto-Apply 60d+ ago
Quality Control Manager (USACE)
Tigua Inc.
Quality manager job in Cary, NC
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)
$71k-109k yearly est. 24d ago
QA Manager
Epic Games 4.8
Quality manager job in Cary, NC
WHAT MAKES US EPIC?
At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
QUALITY ASSURANCE What We Do
The Quality Assurance team owns the testing process, risk management, and quality evaluation of all products and functions across Epic. Our team works closely with developers and production to ensure the best possible user experience for our community and customers.
What You'll Do
We're looking for an experienced QA Manager for our Online team! In this role, you will be a leader in developing a quality strategy. You will be guiding quality for our Distribution team, partnering with other discipline leads, and innovating and improving our quality processes. If you are passionate about leading and mentoring experienced QA professionals in an exciting, fast-paced environment, we'd love to talk to you!
In this role, you will
Lead, manage, and mentor a diverse QA organization within the Distro team, including functional testers and external partners, QA analysts, engineers, and SDETs. Support growth across all QA disciplines while effectively managing and mentoring senior QA SMEs with deep domain and technical expertise.
Own the Distro Quality Strategy and quality signals, accounting for staffing constraints, backend services, and distributable applications. Ensure QA engagement throughout the full development and release lifecycle while using KPIs, metrics, and qualitative signals to assess product quality, testing effectiveness, and release risk, and to drive continuous improvement.
Drive prioritization and execution in a dynamic operating model, where QA supports testing, release validation, and live support. Balance competing priorities, unplanned work, and external requests to prevent QA from becoming a bottleneck while maintaining appropriate quality standards in a low-risk-tolerance environment
Guide release readiness and provide cross-pod oversight, collaborating closely with engineering, product, and stakeholder teams to determine test scope, release timing, and acceptable risk. Collaborate with QA leadership across Epic to identify cross-product risks, dependencies, and mitigation strategies.
Communicate clearly and effectively across teams and stakeholders, explaining priority shifts, risk trade-offs, and release decisions to QA teams, partner teams, and leadership.
Remain technically capable and hands-on when required, stepping in to support testing or releases during coverage gaps, and maintaining sufficient technical depth to engage credibly with QA engineers and developers
What we're looking for
Proven senior experience leading QA teams with mixed skill sets and seniority, including technical and non-technical contributors, external partners, and senior QA SMEs. Demonstrated ability to mentor experienced ICs while providing clear direction and accountability
Proven strong understanding of testing and releasing both backend services and distributable applications, including APIs, services, and client-facing software, with an appreciation for the differing risks and validation strategies involved
Exceptional prioritization and operational judgment, particularly in understaffed, fast-paced environments with multiple stakeholders and low tolerance for risk
Experience supporting release management activities, making informed decisions around test scope, release readiness, and risk acceptance, and setting clear expectations with internal and cross-team stakeholders
Solid technical foundation in modern QA practices, including test automation, CI/CD integration, testability, and quality metrics, with the ability to contribute directly when needed
Strong communication skills, able to clearly explain priority shifts, risks, and trade-offs to QA teams, partner teams, and leadership
Expert-level use of quality metrics and KPIs to guide prioritization, forecast risk, and drive continuous improvement across products, processes, and teams
EPIC JOB + EPIC BENEFITS = EPIC LIFE
Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical.
ABOUT US
Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent.
Like what you hear? Come be a part of something Epic!
Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here.
Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.
$101k-134k yearly est. Auto-Apply 4d ago
Quality Control Managers
Bellair
Quality manager job in Sanford, NC
This role is responsible for ensuring the safety, airworthiness, and regulatory compliance of the company's aircraft maintenance program. The position supports the Director of Maintenance and Quality Assurance teams by overseeing maintenance activities, auditing records and vendors, and ensuring all work complies with FAA regulations, approved maintenance manuals, and company policies. Strong attention to detail, regulatory awareness, and a compliance-driven mindset are essential for success in this role.
Primary Duties:
Ensure that all maintenance performed on company aircraft is done in accordance with approved maintenance manuals and Federal Aviation Regulations.
Responsible for auditing the accuracy of all aircraft records and the accompanying maintenance forms.
Audit the activities of all contract maintenance agencies for compliance with company manual requirements and FAR's.
Responsible for improvements in aircraft records, recording, retention, completeness, and accuracy to maintain the highest standards.
Assist in the liaison between the Quality Assurance Department and other departments to ensure accurate communication related to the airworthiness and safety of aircraft.
Provide oversight of the CASS program at the direction of the DOM.
Ensure company policy and procedures are adhered to.
Supply ongoing developmental insights as well as guarantees for regulatory compliance
Perform receiving inspections of newly purchased, repaired, overhauled parts or continued service components and hardware to ensure proper documentation from approved vendors, absence of shipping damage, proper packing, protection, and airworthiness certification.
Ordering and receiving bulk aviation fuel.
Skills & Qualifications:
Must hold a valid FAA Mechanics Certificate with both airframe and powerplant ratings.
Trained in Audit, Risk Assessment, Root Cause and Human Factors.
Must have strong knowledge of Microsoft Windows Office Suite/Outlook Word, Excel and be able to utilize the Internet.
This position will entail extensive computer work.
Must be able to read, interpret, and follow technical instructions, drawings, schematics, and diagrams.
Must be able to climb a ladder and lift up to 25 lbs.
We offer competitive salary and benefit package which includes health, dental and vision insurance plus PTO and 401k.
Jet Excellence, LLC is an equal opportunity employer that provides equal employment opportunities (EEO).
$78k-112k yearly est. 7d ago
Quality Systems Specialist
Advanced Recruiting Partners
Quality manager job in Raleigh, NC
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.
$65k-87k yearly est. 5d ago
Quality Assurance Operations Manager
Boston Analytical 4.2
Quality manager job in Morrisville, NC
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.
$73k-105k yearly est. 3d ago
Director, Clinical Quality Assurance
Eisai Us 4.8
Quality manager job in Raleigh, NC
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
$94k-136k yearly est. Auto-Apply 60d+ ago
Quality Control Manager
Cooper Tacia General Contracting Company
Quality manager job in Raleigh, NC
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.
$85k-120k yearly Easy Apply 13d ago
Quality Control Manager (USACE)
Tigua Inc.
Quality manager job in McLeansville, NC
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)
How much does a quality manager earn in Durham, NC?
The average quality manager in Durham, NC earns between $57,000 and $127,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.
Average quality manager salary in Durham, NC
$85,000
What are the biggest employers of Quality Managers in Durham, NC?
The biggest employers of Quality Managers in Durham, NC are: