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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMP inspectionGDP inspectionregulatory compliancedata integrityinspection lifecycle managementquality management systems (QMS)digital quality systemsinspection metricscontinuous improvementoperational excellence

Soft Skills

stakeholder engagementexecutive communicationstrategic thinkingtactical executionleadershipcollaborationproblem-solvingadaptabilityanalytical skillstraining development