Pfizer

Compensation

Full Description

Description: Develop and lead complex projects, while ensuring quality and inspection readiness.Evaluate and review clinical and commercial drug batches to ensure product and process documents align with established specifications and compliance standards.Identify deviations in manufacturing and packaging processes, approving investigations and change control activities to maintain compliance with configuration management policies.Collaborate with Pfizer Global Supply colleagues to develop procedures that increase efficiency and maintain high-quality standards.Represent Manufacturing Quality Assurance (MQA) as a subject matter expert at cross-functional forums and projects, supporting global manufacturing sites and regulatory operations.Provide clear, direct, and timely communication to stakeholders, driving customer relationships, delivering quality improvement recommendations, and implementing continuous improvement initiatives. Requirements: BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experienceExperience supporting or leading Quality audits and developing/managing remediation plansRelevant pharmaceutical experience including previous Pharmacovigilance/clinical Quality Assurance experience conducting a broad range of auditsBroad knowledge of relevant regulatory current Good Manufacturing Practices (part of GxP) audit frameworks that apply to pharmaceutical operations, its trends and expectations, and familiarity with other Good Practice concepts and global regulationsStrong verbal and written communication, including presentation skillsStrong project management skills Benefits: 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.