Manager, GMP Audits

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

📋 Description

• Independently strategize and oversee intricate audits of material suppliers, service providers, Pfizer country offices, and other regulated operations.

• Engage in audits of low-complexity commercial and clinical manufacturing sites along with contract manufacturers.

• Conduct initial and routine audits with minimal supervision.

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

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

• Assist in the implementation and management of quality programs for functional areas, vendor entities, and assessments.

• Address issues by applying SOPs, GMP/GDP regulations, and local compliance standards.

• Work alongside RQA colleagues on cross-GxP audit initiatives.

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

• Detect risks and instances of non-compliance within Pfizer’s GxP-regulated operations.

• Collaborate with RQA colleagues and auditees from Pfizer functional lines and vendors.

⛳️ Requirements

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

• 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 are essential when utilizing AI tools.

• Willingness to embrace new audit technologies and contribute to the ongoing enhancement of digital audit workflows and methodologies.

• Extensive working knowledge of business concepts and quality operations.

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

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

• Excellent organizational and project management abilities.

• Proficient technical writing skills.

• Capability to identify trends within data and leverage insights to make informed recommendations.

• Skill in synthesizing information and deriving conclusions.

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

• 5–7 years of relevant experience, preferably in operations or auditing.

• Familiarity with data analytics and its interpretation.

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

• Ability to work autonomously within a matrix model while also thriving in a team-oriented environment.

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

🏝️ Benefits

• Equal opportunity employer.

• Remote work location assignment.