Pfizer

Quality Compliance Lead

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Andover • Connecticut • Massachusetts • United States

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Salary

💰 $124,400 - $201,400 per year

Job Level

Senior

About the role

  • Serve as the primary compliance lead for BTx PSOQ, offering strategic guidance on global regulations, industry standards, and internal quality policies.
  • Lead the development and implementation of proactive compliance strategies to cultivate a culture of quality and continuous improvement.
  • Act as PSOQ compliance lead for regulatory inspections and audits.
  • Collaborate with Pfizer corporate auditors on conducting internal audits.
  • Lead cross-functional compliance projects across multiple sites with the global PS team to ensure regulatory readiness and reduce risks.
  • Collaborate with auditors and stakeholders to influence broader processes and standards.
  • Deliver compliance support through risk assessments and advise stakeholders on risk prioritization and remediation strategies.
  • Develop and implement risk management strategies for complex, multi-site operations and major capital projects.
  • Work with cross-functional teams to implement quality activities and ensure compliance.
  • Review SOPs and documents for regulatory or internal requirements.
  • Create and maintain quality tools and conduct compliance training.
  • Manage quality assessments, risk management, CAPA plans, and/or other compliance documentation.
  • Track quality metrics to support audit and inspection readiness to ensure compliance.
  • Oversee compliance aspects for major capital projects, ensuring regulatory and internal standards are met throughout all phases of project lifecycles.
  • Lead compliance projects that impact multiple sites and contribute to the global PSOQ compliance strategy.
  • Partner with key stakeholders for quality reviews, audits, investigations, and process improvement initiatives.
  • Drive innovative solutions to enhance efficiency and compliance across GMP operations.

Requirements

  • BA/BS with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience in GMP compliance and/or operations quality oversight.
  • Demonstrated expertise in regulatory requirements, risk management, and audit leadership.
  • Ability to influence across functions and lead complex projects without direct authority.
  • Excellent communication and negotiation skills, with experience interfacing with regulatory agencies.
  • Extensive experience in enterprise-wide compliance leadership and audit management.
  • Exceptional presentation & facilitation skills with an ability to succinctly & creatively present messages.
  • Willingness to contribute fresh & innovative ideas.
  • Fluent in English.
Benefits
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Applicant Tracking System Keywords

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

Hard Skills & Tools
GMP compliancerisk managementaudit leadershipcompliance documentationquality assessmentsCAPA plansquality metricsregulatory inspectionsinternal auditsSOP review
Soft Skills
communication skillsnegotiation skillsinfluencing skillsproject leadershippresentation skillsfacilitation skillscollaborationcreativitystrategic guidancecontinuous improvement