Quality Compliance Senior Manager

Quality Compliance Senior Manager, GMP/GDP Inspections Global Process Owner (GPO)

Primary Responsibilities:
- Own the end-to-end GMP/GDP inspection process, including inspection preparation, conduct, response development, commitment tracking, and closure.
- Ensure standardized governance, roles, and controls for consistent inspection execution across sites and regions.
- Lead continuous improvement of inspection processes using lessons learned, inspection trends, and health authority feedback.
- Provide global process leadership during GMP/GDP inspections, supporting sites and enterprise stakeholders through inspection activities and regulatory interactions.
- Serve as business owner for the DQMS Operations Inspection module, including:
- Functional requirements and lifecycle management
- Data integrity, usability, and process alignment
- Ongoing enhancements to support inspection execution, outcome tracking, and reporting
- Partner with QMS, Digital, IT, ILM, and site stakeholders to ensure the module supports global and site-based inspection activities.
- Liaise with GCP, GLP, and GPvP Inspection Process Owners to align inspection lifecycle elements.
- Harmonize inspection practices, metrics, and governance models across GxP domains.
- Establish, maintain, and govern a global inspection metrics control plan (readiness indicators, outcomes/trends, commitment timeliness/effectiveness) and ensure data capture, maintenance, and integrity.
- Oversee inspection-related standards, policies, procedures, and guidance within the QMS.
- Lead gap assessments for new regulatory requirements and ensure alignment to regulatory commitments and inspection findings.
- Partner with Learning & Development on inspection-related training and capability-building.
- Benchmark industry best practices and emerging trends/technologies, including appropriate use of GenAI tools.
- Collaborate across Regulatory Compliance, IDQ, ESQ, PAQ, R&D, and other functions to maintain and improve the end-to-end GMP/GDP inspection lifecycle.
- Reports into the Head of the Inspection Lifecycle Management organization.

Basic Qualifications:
- Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience in Pharma/Biotech OR
- Master’s degree and 4 years of Quality, Operations, and/or Regulatory Compliance experience in Pharma/Biotech OR
- Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience in Pharma/Biotech OR
- Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience in Pharma/Biotech OR
- High school diploma/GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience in Pharma/Biotech

Preferred Qualifications:
- Experience leading or governing GMP/GDP inspections and regulatory interactions
- Deep knowledge of global health authority inspection expectations and inspection lifecycle management
- Experience owning/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 operational excellence and continuous improvement across enterprise Quality processes
- Based in U.S. or Western Europe time zones
- Ad hoc travel for workshops if necessary for process/system improvements

Application Instructions:
- Apply now.
- No application deadline; applications will continue until a sufficient number is received or a candidate is selected.

Benefits (Total Rewards Plan; if eligible):
- Comprehensive employee benefits package (Retirement and Savings Plan, medical/dental/vision, life/disability insurance, flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive plan for field sales representatives)
- Stock-based long-term incentives
- Time-off plans
- Flexible work models where possible