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 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, data integrity, and change controls while partnering with Manufacturing, Engineering, and Regulatory teams. Lead investigations of deviations and complaints, oversee supplier quality and risk management programs, and coach the QA Compliance and Systems team through talent development and training governance. Establish a culture of accountability and continuous improvement to support the site's long-term growth and transformation journey.
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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