Senior Manager, GMP GDP Auditor

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $124.4k - $207.4k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Independently plan and lead complex audits of material suppliers, service providers, contract manufacturers and Pfizer country offices • Perform initial, routine and for-cause audits and due diligence assessments with minimal oversight • Support creation, testing, refinement and adoption of AI-enabled audit tools • Use AI tools responsibly for targeted audit preparation and execution • Execute audit strategy, lead process audits and perform special assessments • Review audit reports from outsourced or routine audits • Assess audit plans and quality metrics to identify potential risk areas • Support regulatory inspections as needed • Identify and drive audit process improvements • Deliver GMP awareness sessions internally and externally with manager oversight • Collaborate with QA colleagues across Pfizer locations and functions to standardize auditing approaches • Engage in discussions regarding changing regulatory-environment needs • Work with RQA colleagues on cross-GxP audit plans • Coach colleagues and lead training for routine and non-routine site and process audits • Advise business representatives on complex-audit outcomes and process-improvement activities • Provide leadership, influence and recommendations to meet changing GMP business needs • Conduct field-based activities including walking, observing physically and electronically, and lifting to assess quality and compliance risks

🎯 Requirements

• Bachelor's degree with at least 6 years of experience; OR master's degree with at least 5 years of experience; OR PhD with 1+ years of experience • Advanced knowledge and understanding of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA and TGA • Knowledge of international standards, including ISO and WHO • Human oversight, professional judgment and source verification when using AI tools • Willingness to adopt new audit technologies and contribute to digital audit workflow improvements • Comprehensive working knowledge of business concepts and quality operations within Pfizer • Critical-thinking expertise and ability to define and implement strategic audit approaches • Strong use of quality and auditing frameworks • Organizational and project management skills • Ability to suggest and implement new audit techniques and approaches • Ability to identify data trends and apply insights to recommendations and decisions • Ability to bring recommendations to stakeholders for discussion and input • Ability to lead and progress operational improvements • Domain expertise in two or more technical areas, such as API or solid oral dosages • Ability to work with ambiguity and adapt plans • Ability to interpret qualitative and quantitative data for decision-making and business impact assessment • Specialist expertise in complex technologies, such as sterile biologics, small molecules or MDCP • Ability to travel up to 60% domestically and internationally • Must be authorized to be employed in the U.S. by any employer • Permanent work authorization in the United States required • U.S. work visa sponsorship is not available now or in the future

🏖️ Benefits

• Global Performance Plan 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