Audit, Inspection Management and Regulatory Surveillance Strategic Process Lead

This is a fully remote position, open to applicants in Missouri.

📋 Description

• Lead, create, and support the execution of the PharmSci Audit strategic plan.

• Collaborate with RQA on the internal audit strategy.

• Examine data and metrics that aid in audit and inspection management, regulatory compliance, and strategic planning.

• Standardize practices for audit, inspection management, and regulatory oversight across the global PharmSci network.

• Assist in the implementation of Global Inspection Management Systems and Tools.

• Formulate strategies and implement metrics aimed at performance enhancement.

• Evaluate metrics and feedback to enhance effectiveness while aligning with processes and stakeholder expectations.

• Create procedures and implementation strategies for managing audits, inspections, and regulatory information.

• Collaborate with business units to ensure audit and inspection readiness.

• Support PharmSci audit, inspection, and regulatory information systems.

• Act as a Quality System Subject Matter Expert and assist in corporate and regulatory audits.

• Review SOPs, identify gaps, and contribute insights on audits, inspections, and regulatory information.

• Provide subject matter expertise to global and site-specific clients.

• Lead and engage in projects that support organizational strategies and objectives.

• Manage communication with stakeholders regarding audit, inspection management, and regulatory surveillance activities and modifications.

• Lead Communities of Practice focused on audit, inspection management, and regulatory surveillance.

• Deliver regular reports and results to quality councils, management teams, and stakeholders.

• Enhance operational efficiency, effectiveness, and integration throughout the drug development process.

• Foster a robust culture of inspection readiness among Pharmaceutical Sciences and related stakeholders.

• Continuously monitor and maintain industry-wide expertise in audit, inspection management, and regulatory surveillance.

⛳️ Requirements

• BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience.

• Proven track record of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, mentor and develop others, guide colleagues, and create substantial business impact.

• Audit certification, along with management and performance experience.

• Strong experience in Board of Health, Regulatory, and Audit matters.

• Proficiency in GMP/GDP audits, inspections, and quality oversight.

• Excellent project management, organizational, and planning abilities.

• Outstanding written and verbal communication and collaboration skills.

• Minimal travel related to audits.

• Candidates must be authorized to work in the U.S. by any employer.

• U.S. work visa sponsorship is not currently available and will not be in the future.

• Permanent work authorization in the United States is mandatory.

🏝️ Benefits

• Pfizer’s Global Performance Plan with a bonus target of 17.5% of base salary.

• Eligibility for a share-based long-term incentive program.

• 401(k) plan with Pfizer Matching Contributions.

• Additional Pfizer Retirement Savings Contribution.

• Paid vacation, holidays, and personal days.

• Paid caregiver/parental and medical leave.

• Comprehensive medical, prescription drug, dental, and vision coverage.

• Relocation assistance may be available based on business needs and/or eligibility.