Senior Quality Compliance Manager
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Job Description
Senior Manager overseeing GMP/GDP inspections for a global biotech company. Leading quality compliance efforts and regulatory interactions to ensure operational excellence.
Responsibilities:
- Owns the end‑to‑end GMP/GDP inspection process, including inspection preparation, conduct, response development, commitment tracking, and closure.
- Ensures standardized governance, roles, and controls are in place to support consistent execution of inspections across sites and regions.
- Leads continuous improvement of inspection processes through lessons learned, inspection trends, and feedback from health authority interactions.
- Provides global process leadership during GMP/GDP inspections, supporting sites and enterprise stakeholders through inspection activities and regulatory interactions.
- Serves as business owner for the DQMS Operations Inspection module, with accountability for: Functional requirements and lifecycle management; Data integrity, usability, and process alignment; Ongoing enhancements to support inspection execution, outcome tracking, and reporting.
- Partners with QMS, Digital, IT, ILM and Site stakeholders to ensure the module effectively supports global and site‑based inspection activities.
- Acts as primary liaison with GCP, GLP, and GPvP Inspection Process Owners to establish consistency and alignment across inspection lifecycle elements where appropriate.
- Establishes, maintains, and governs a global inspection metrics control plan, including: Inspection readiness indicators; Inspection outcomes and trends; Commitment timeliness and effectiveness.
- Owns data capture, maintenance, and integrity for inspection metrics supporting global and site‑based management reviews.
- Oversees inspection‑related standards, policies, procedures, and guidance documents within the QMS.
- Leads gap assessments to new regulatory requirements and ensures alignment to regulatory commitments and inspection findings.
- Partners with Learning & Development to define inspection‑related training content and capability‑building strategies.
- Performs industry benchmarking and research to identify best practices, emerging trends, and enabling technologies, ensuring alignment with Quality governance expectations, including appropriate use of GenAI tools.
Requirements:
- Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
- OR Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
- OR Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
- OR Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
- OR High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector
- Prior experience leading or governing GMP/GDP inspections and regulatory interactions
- Deep knowledge of global health authority inspection expectations and inspection lifecycle management
- Experience owning or governing digital quality systems supporting inspections and regulatory commitments
- Ability to operate strategically and tactically in a complex, global environment
- Strong stakeholder engagement and executive communication skills
- Demonstrated capability in driving operational excellence and continuous improvement across enterprise Quality processes
Benefits:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
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