Audit, Inspection Management and Regulatory Surveillance Strategic Process Lead

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🔥 0 minutes ago

🏰 Missouri – Remote

🏰 Missouri – Remote

💵 $124.4k - $207.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Lead, develop and support execution of the PharmSci Audit strategic plan • Partner with RQA on the internal audit plan • Analyze data and metrics supporting audit and inspection management, regulatory compliance, and strategic planning • Standardize audit, inspection management and regulatory surveillance practices across the global PharmSci network • Help implement Global Inspection Management Systems and Tools • Develop strategies and deploy metrics for performance improvement • Analyze metrics and feedback to improve effectiveness and align with process and stakeholder needs • Develop procedures and implementation plans for managing audits, inspections and regulatory information • Partner with business lines on audit and inspection readiness • Support PharmSci audit, inspection and regulatory information systems • Serve as a Quality System Subject Matter Expert and support corporate and regulatory audits • Review SOPs, determine gaps, and provide input on audits, inspections and regulatory information • Provide subject matter expertise to global and site customers • Lead and participate in projects supporting organizational strategy and priorities • Manage stakeholder communications for audit, inspection management and regulatory surveillance activities and changes • Lead Communities of Practice for audit, inspection management and regulatory surveillance • Provide regular reporting and results to quality councils, management teams and stakeholders • Improve process operational efficiency, effectiveness, and integration across end-to-end drug development processes • Develop a strong inspection-readiness culture across Pharmaceutical Sciences and related stakeholders • 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 • Demonstrated diverse leadership experiences and capabilities, including ability to influence and collaborate with peers, develop and coach others, oversee and guide colleagues, and create significant business impact • Audit certification, management and performance experience • Strong Board of Health, Regulatory and Audit experience • Strong GMP/GDP audit, inspection and quality oversight skills • Strong project management, organization, and planning skills • Excellent written and verbal communication and collaboration skills • Minimal audit-related travel • Candidates must be authorized to be employed in the U.S. by any employer • U.S. work visa sponsorship is not available now or in the future • Permanent work authorization in the United States is required

🏖️ Benefits

• Pfizer’s Global Performance Plan with a bonus target of 17.5% of base salary • Share-based long-term incentive program eligibility • 401(k) plan with Pfizer Matching Contributions • Additional Pfizer Retirement Savings Contribution • Paid vacation, holiday and personal days • Paid caregiver/parental and medical leave • Medical, prescription drug, dental and vision coverage • Relocation assistance may be available based on business needs and/or eligibility