Pfizer

Manager, GMP/GDP Audits – Regulatory Quality Assurance

Rabat

CDI / Temps pleinTélétravail5–10 ansLicence / Bac+3AnglaisAudit / Contrôle de gestionPharmaceutique

L’essentiel du poste

Résumé par Postule AI

Manager, GMP/GDP Audits at Pfizer leads independent quality audits of manufacturing and distribution operations globally. This remote role requires extensive expertise in good distribution practices, global GMP/GDP regulations (FDA, EMA, ICH, etc.), and quality standards. The position involves planning and executing audits across Pfizer operations, vendors, and contract manufacturers, with responsibility for identifying compliance risks and ensuring adherence to regulatory requirements. Candidates should have 5–7 years of operational or auditing experience, strong technical writing and project management skills, and proficiency with emerging audit technologies and AI tools.

Vos missions

  • Plan, lead, and participate in GMP/GDP audits of Pfizer manufacturing, distribution, and vendor operations with minimal oversight
  • Leverage AI tools responsibly to support audit preparation, execution, reporting, and follow-up with professional judgment
  • Execute quality programs and assessments related to functional areas and vendor entities
  • Resolve compliance issues using knowledge of SOPs, GMP/GDP regulations, and local standards
  • Collaborate with RQA colleagues on cross-GxP audit plans and manage stakeholder feedback

Profil recherché

  • You have 5–7 years of pharmaceutical auditing or quality operations experience
  • You possess deep expertise in GMP/GDP regulations and global distribution practices
  • You are comfortable with field-based work and frequent international travel
  • You are proactive in adopting new technologies and improving audit methodologies
  • You can work autonomously in a matrix environment while collaborating across teams

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Role Summary

Regulatory Quality Assurance (RQA) is an independent quality audit function within Pfizer accountable for identifying risks and non-compliance in GxP regulated operations. The GMP/GDP Audit function performs audits of Pfizer manufacturing and distribution operations, license entities, country offices, material suppliers, service providers, and contract manufacturers involved in GMP/GDP manufacturing, packaging, testing, and distribution of APIs, clinical trial materials, and commercial biopharmaceutical products worldwide.

Main Responsibilities

  • Independently plan, lead, and participate in GMP/GDP audits of Pfizer operations, vendors, and contract manufacturers, performing initial and routine audits with minimal oversight
  • Leverage AI tools responsibly to support audit preparation, execution, and reporting while applying professional judgment and source verification
  • Engage with complex audits including process audits and review low-complexity outsourced audits
  • Execute quality programs related to functional areas, vendor entities, and compliance assessments
  • Resolve compliance issues using knowledge of SOPs, GMP/GDP regulations, and local standards
  • Collaborate with RQA colleagues on cross-GxP audit plans and manage multiple stakeholders to synthesize feedback

Key Requirements

  • Education: Bachelor's degree (or equivalent) in pharmaceutical or natural sciences
  • Expertise: Extensive knowledge of good distribution practices, global distribution models, MAH and WDA regulatory requirements
  • Regulatory Knowledge: Advanced understanding of global regulations (FDA, ICH, PIC's, EMA, HC, ANVISA, TGA) and international standards (ISO, WHO)
  • Technical Skills: GMP/GDP working knowledge, data analytics, technical writing, project management, and critical thinking
  • Technology Specialization: At least one conventional technology area (e.g., API, solid oral dosages)
  • AI Proficiency: Willingness to adopt new audit technologies and contribute to digital audit workflow improvements

Preferred Qualifications

  • 5–7 years of operational or auditing experience
  • Working knowledge of data analytics and interpretation
  • Expertise in vendor audits plus one or more technology areas (MDCP, sterile biologics, small molecules, GDP)
  • Ability to function autonomously in matrix and team environments

Physical and Travel Requirements

  • Field-based position involving walking, observing, and lifting to assess quality and compliance risks
  • Up to 40% travel, including domestic and international assignments

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