Manager, GMP Audits

🔥 12 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Independently plan and lead complex audits of material suppliers, service providers, Pfizer country offices, and other regulated operations • Participate in audits of low-complexity commercial and clinical manufacturing sites and contract manufacturers • Perform initial and routine audits with minimal oversight • Use AI tools responsibly to support targeted audit preparation and execution • Engage in complex process audits or review low-complexity outsourced audits • Support and execute quality programs for functional areas, vendor entities, and assessments • Resolve issues using SOPs, GMP/GDP regulations and standards, and local regulations • Collaborate with RQA colleagues on cross-GxP audit plans • Manage multiple stakeholders, synthesize feedback, and take action with manager support • Identify risks and non-compliance across Pfizer’s GxP-regulated operations • Collaborate with RQA colleagues and auditees from Pfizer functional lines and vendors

🎯 Requirements

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent • Advanced knowledge and understanding of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, and TGA • Knowledge of international standards, including ISO and WHO • Human oversight, professional judgment, and source verification when using AI tools • Willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies • Comprehensive working knowledge of business concepts and quality operations • Critical-thinking ability to identify and assess areas of greatest risk and develop strategic audit approaches • Understanding of quality and auditing frameworks and their application • Proficient organizational and project management skills • Technical writing skills • Ability to identify trends within data and apply insights to make recommendations • Ability to synthesize information and draw conclusions • At least one conventional technology specialization, such as API or solid oral dosages • 5–7 years of experience, operational or auditing preferred • Working knowledge of data analytics and interpretation • Expertise in vendor audits plus one technology area, such as MDCP, sterile biologics, small molecules, or GDP • Ability to function autonomously in a matrix model and in a team environment • Ability to travel up to 40% of the time, including domestic and international travel

🏖️ Benefits

• Equal opportunity employer • Remote work location assignment

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