Director, Quality Systems & Compliance

About the role

The Director, Quality Systems and Compliance provides strategic leadership for the site’s Pharmaceutical Quality System (PQS), Audits and Inspections, Documentation Management, GxP Learning, and Quality Compliance programs. The role ensures sustainable inspection readiness, maintains compliance with global regulatory requirements, and drives continuous improvement across quality systems. The Director serves as a key site leader during customer audits and regulatory inspections and partners across functions to strengthen quality culture, data integrity, and operational excellence. The Director fosters a strong Quality Culture across teams and contributes to cohesive implementation of quality systems at the Holly Springs site, aligning with organizational goals and regulatory expectations.

Responsibilities

• Develop strategic plans for Quality Systems and support team; set measurable goals; oversee supervision, development, and performance of team to foster long-term growth and a high-performing team environment.
• Ensure and oversee adherence, maintenance, and continuous improvement of PQS to confirm alignment with current GMP, GDP, and regulatory requirements through effective implementation of global policies while meeting local operational needs.
• Own the site Inspection Readiness Program; build and ensure sustainable readiness through risk-based oversight of PQS subsystems, management reviews, metrics, and escalation processes.
• Drive inspection readiness, ensure adherence to global health regulations; lead end-to-end regulatory inspections and customer audits; guide response strategies and author/review formal responses to inspectional observations.
• Ensure GxP compliance through robust quality systems, regulatory intelligence assessment, risk management, continuous improvement, and driving a proactive quality culture.
• Develop and oversee robust corrective and preventive actions (CAPAs), remediation plans, and audit finding responses to prevent recurrence for both local and global site-related commitments; verify effectiveness through metrics and periodic reviews.
• Ensure timely availability of site quality performance data, including metrics for quarterly management reviews, to identify emerging regulatory trends and monitor performance against agreed targets for driving improvements and achieving quality objectives.
• Identify and lead Quality Systems process improvement initiatives to enhance efficiency while maintaining compliance, ensuring alignment with industry best practices and regulatory expectations.
• Partner with clients and internal stakeholders across functions to support Quality initiatives and innovation projects; collaborate cross-functionally to ensure seamless integration of Quality Systems into broader operational goals.
• Represent the site in global forums to align local practices with global strategies and share best practices.
• Drive team efforts in curating critical knowledge to develop best practices in Quality and Operational disciplines.
• Mentor and motivate employees; evaluate team performance regularly; implement measures to improve productivity and engagement; identify high-potential employees for further development opportunities.
• Administer company policies such as time off, shift work, and inclement weather that directly impact employees.
• Complete required administrative tasks (e.g., timecard approvals, time off approvals, expense reports).
• Participate in the recruitment process and retention strategies to attract and retain talent; address performance gaps, employee questions and concerns; partner with HR as needed for resolution.

Requirements

• Bachelor’s degree in Engineering or Life Science with 10+ years of related experience; OR Master’s degree in Engineering or Life Science with 8+ years of related experience.
• 6+ years of people management, leadership, and team management experience.
• 2+ years of experience leading and developing leaders (managers/supervisors).
• Experience working in a changing, project-driven organization.
• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.
• Experience with ICH Q7, 21 CFR part 820 and part 11, EU GMP vol 4, and ALCOA+ guidelines.
• Experience collaborating and interacting with a global team.
• Experience with regulatory inspections from multiple global health authorities.
• Experience managing complex global regulatory interactions.
• Experience leading pre-approval inspections (PAIs).
• Experience establishing quality metrics and performance.

Preferred Qualifications

• 10+ years of experience in a GMP quality assurance (QA) or Regulatory Affairs role in a commercial biopharmaceutical facility.
• Experience from other GMP functions (manufacturing, MSAT, engineering).
• Strong track record of driving operational excellence.
• Experience with TrackWise and Veeva.

Knowledge, Skills, and Abilities

• Collaborative attitude with the willingness to work with global peers and cross-functional teams to drive company/department-level change and efforts for strengthening compliance, Quality mindset, and operational excellence initiatives.
• Strong analytical, problem-solving, organizational, and risk-based decision-making skills, with attention to detail and a solution-oriented mindset; ability to manage multiple priorities in a fast-paced, highly interactive environment.
• Demonstrated ability to efficiently execute audits and inspections, communicate with external parties and health authorities, and build trust with inspectors.
• Strong understanding of 21 CFR (Parts 210/211, 600/610, 11), EU GMP (EudraLex Vol 4, Annexes incl. Annex 1), ICH (Q7–Q10/Q12), GDP, GLP, GCP (ICH E6/E8), and medical devices/IVDs (21 CFR 820 (QMSR), EU MDR/IVDR, ISO 13485, ISO 14971, ISO 9001).
• Advanced knowledge of Data Integrity and ALCOA+ principles.
• Ability to influence at all levels, including senior leadership, and provide feedback in adherence with company values.
• Exceptional written and verbal communication skills, with the ability to remain calm and credible under pressure, adapt to differing audiences, advise on difficult matters, and present complex information effectively.
• Strong team leadership; demonstrated ability to hire, motivate, and develop top technical talent to build and lead a high-performing team, projects, and programs while directing allocation of resources.
• Willingness to travel domestically and internationally, up to 20%; flexible to support a 24/7 manufacturing facility.

Physical Requirements

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 120 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.