Head Quality Systems and Compliance (Assoc Dir)
$138,600–$257,400 year
On-siteDurham, North Carolina, United States
Job Summary
Lead the site Quality Management System and ensure compliance with Good Manufacturing Practice requirements and regulatory standards. Drive continuous inspection readiness by leading preparation for corporate, customer, and Health Authority audits. Provide oversight of quality systems including deviations, corrective and preventive actions, change controls, data integrity, and key performance indicators. Partner with Manufacturing, Engineering, and Regulatory teams to support operations, technology transfers, and validation activities. Lead investigations of deviations, complaints, and compliance issues while overseeing supplier quality and risk management programs. Coach and develop the QA Compliance and Systems team through resource planning, performance management, and training governance. Advance digital enablement and continuous improvement initiatives to strengthen quality performance and support site transformation.
Required Qualifications
- Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline
- advanced degree
- Minimum 8-10 years of experience in pharmaceutical manufacturing
- Prior experience in oral solid dose manufacturing
- Demonstrated leadership experience managing teams, developing talent, driving performance, fostering training compliance, and building a culture of accountability and collaboration
- Significant experience leading FDA inspections, regulatory interactions, audit readiness activities, and inspection remediation efforts
- Strong experience leading Quality Systems programs, including deviations, corrective and preventive actions, change control, data integrity, validation, and compliance oversight
- Proven ability to lead risk management, continuous improvement, and compliance initiatives in highly regulated manufacturing environments
Desired Qualifications
- Previous involvement with facility start-ups, qualifications, validations, transfers
- Qualifications or certification in Lean Management, Operational Excellence, or comparable continuous improvement methodologies
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