Manager, GMP Audits

This is a fully remote position, open to applicants in China.

📋 Description

• Independently organize and oversee intricate audits for material suppliers, service providers, and Pfizer country offices.

• Take part in audits for commercial and clinical manufacturing sites and contract manufacturers that are of low complexity.

• Conduct initial and routine audits with minimal supervision.

• Utilize AI tools responsibly to aid in audit preparation and execution.

• Engage in complex process audits or evaluate low-complexity outsourced audits.

• Assist in implementing and executing quality programs concerning functional areas, vendor entities, and assessments.

• Address issues using SOPs, GMP/GDP regulations and standards, as well as local regulations.

• Collaborate with RQA colleagues to develop cross-GxP audit plans.

• Manage multiple stakeholders, consolidate feedback, and take action with managerial support.

• Work alongside RQA colleagues and auditees across Pfizer and vendor functional lines.

⛳️ Requirements

• Bachelor's degree (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent qualifications.

• In-depth knowledge and understanding of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, and TGA.

• Familiarity with international standards such as ISO and WHO.

• Human oversight, professional judgment, and source verification when utilizing AI tools.

• Openness to adopting new auditing technologies and contributing to the continuous enhancement of digital audit workflows and methodologies.

• Thorough working knowledge of business concepts and quality operations.

• Critical thinking skills to identify and evaluate areas of highest risk and formulate strategic audit approaches.

• Understanding of quality and auditing frameworks and their practical application.

• Strong organizational and project management capabilities.

• Proficient technical writing skills.

• Ability to recognize trends within data and apply insights to make informed recommendations.

• Capacity to synthesize information and draw conclusions effectively.

• At least one specialization in conventional technology, such as API or solid oral dosages.

• 5–7 years of experience, preferably in operational or auditing roles.

• Working knowledge of data analytics and its interpretation.

• Expertise in vendor audits along with one technology area, such as MDCP, sterile biologics, small molecules, or GDP.

• Ability to operate independently in a matrix model as well as within a team environment.

• Willingness to travel up to 40% of the time, including both domestic and international travel.

🏝️ Benefits

• Equal opportunity employer.

• Remote work location assignment.