• Manage Quality Compliance Oversight and site quality system activities.
• Support Quality Council / Management Review forums and communicate site quality status.
• Develop and monitor site compliance metrics.
• Manage Quality Technical Agreements (QTA) with internal and external partners.
• Lead and execute internal GMP audits.
• Coordinate external audits and regulatory inspections, including responses and CAPA tracking.
• Manage the site's Inspection Readiness Program.
• Support CAPA, investigations, corrective action plans, and compliance issue resolution.
• Conduct regulatory reviews, gap assessments, and Knowledge Management activities.
• Manage supplier/vendor qualification and compliance activities.
• Perform periodic document reviews and compliance gap assessments.
• Own and update SOPs/procedures for assigned responsibilities.
• Lead cross-functional compliance projects and present findings to senior management.
• Collaborate with Site Operations and Quality Management to resolve compliance issues.

• Bachelor's degree, preferably in Science or Engineering, or equivalent combination of education and experience.
• Minimum 7 years of relevant progressive experience in pharmaceutical or related industry, or equivalent combination.
• Strong experience with GMP Quality Systems and regulatory compliance.
• Experience with internal/external audits and inspection readiness.
• Experience with CAPA, investigations, and compliance issue resolution.
• Quality documentation review/approval and Quality Technical Agreements experience.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Ability to work independently and make decisions in complex situations.
• Pharmaceutical manufacturing/cGMP environment experience is preferred.

• 3+ years performing GMP Quality System audits/measurements.
• Regulatory inspection support experience.
• Experience writing/negotiating Quality Technical Agreements.
• ASQ CQE/CQA or equivalent certification.
• Experience with FDA, EMA, DEA, EPA and other applicable regulatory requirements.

• SAP / Oracle
• LIMS
• TrackWise
• Veeva
• Qdocs
• Learning Management Systems (LMS)
• Microsoft Office
• Pharmaceutical Quality Management Systems

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.