Third Party Quality Auditor
About the job
- A Bachelor's degree in Science, Pharmacy, Biotechnology, or Microbiology is required.
- At least 7 years of experience in a quality and/or regulatory function at a reputed pharmaceutical or biopharmaceutical company, including experience performing third-party audits across categories such as active pharmaceutical ingredients, excipients, chemicals, raw materials, drug product manufacturers, and service providers.
- Thorough knowledge of current Good Manufacturing Practices and the Code of Federal Regulations for drugs and biologics, and knowledge of quality functions in the pharmaceutical industry.
- Experience conducting on-site audits and inspections and facing regulatory or health-authority inspections and audits.
- Thorough knowledge of corrective and preventive action systems is required.
- Thorough knowledge of and experience applying Good Manufacturing Practice requirements.
- Operational experience in pharmaceutical, biotechnology, medical device, or vaccine manufacturing.
- Skills in analytical work, quality assurance, auditing, and training.
- Readiness to travel.
- Native-level Chinese and fluency in spoken and written English.
- Organize, plan, and perform third-party quality audits upon request according to the annual audit program.
- Independently assess third-party quality systems for material compliance and regulatory and quality requirements.
- Identify gaps and improvement areas, communicate results as needed, and ensure corrective and preventive action is available for complete communication.
- Act as an interface between third parties and the sites using them to facilitate improvement follow-up and exchange of quality information.
- Participate in qualification of new auditors in the hub by conducting audits with them and providing expertise in third-party quality assessment.
- Support audits led by other auditors when specific expertise is needed, including for-cause audits with user-site representatives and audits involving highly sophisticated topics.
- Interact with Global Quality Third Parties Audit Management and Third Parties Quality Management colleagues to support enhancements as required.
- Propose solutions to improve the third-party quality audit process.
- Participate in quality documentation updates as required.
- Provide quality assurance and technical support to third-party manufacturers, contract manufacturing organizations, their operations, affiliates, and other stakeholders.
- Ensure compliance with corporate and divisional quality assurance policies, procedures, standards, specifications, and applicable country-specific regulations based on third-party manufacturer or contract manufacturer location and markets.
- Ensure compliance with corporate and divisional quality assurance requirements and identify or resolve quality gaps and issues related to product design, manufacturing quality programs, and product start-ups at third-party manufacturers and contract manufacturing organizations.
- Support root cause analysis investigations of quality events as required.
- Use knowledge of quality assurance systems and problem-solving tools to provide solutions to quality issues.
- Lead the Quality Compliance team to ensure current Good Manufacturing Practice compliance and inspection readiness.
- Manage supplier audit programs and follow up on regulatory audits.
- Oversee regulatory intelligence and contribute to on-site Quality Risk Management.
- Identify and propose process and procedure improvements.
- Manage supplier audits and ensure current Good Manufacturing Practice and standard operating procedure alignment.
- Track market developments and regulatory changes.
- Contribute to team effectiveness, identify risks, and formulate improvements.
- Manage work processes efficiently and comply with applicable laws.
- Follow up on corrective and preventive actions.
- Monitor Food and Drug Administration and European Medicines Agency requirements and share knowledge.
- Coach and direct the team, conduct evaluation interviews, and assess training needs.
- Assess supplier quality for material compliance and regulatory requirements, including corrective and preventive action for third-party sites.
- Serve as a local quality contact among suppliers, Global Quality Suppliers, and IA sites to facilitate exchange of quality information.
- Organize daily work according to group-defined workload, and prepare monthly reports and indicators to support priority decisions.
- Conduct on-site and remote audits of Good Practice-regulated and health-regulated third-party vendors to ensure compliance with regulations and company policies.
- Prioritize audit planning to meet audit, assessment, and monitoring plans.
- Collaborate with regional stakeholders to prepare for inspections.
- Experience managing third-party manufacturers and/or contract manufacturing organizations is preferred.
- Experience working on manufacturing sites is an added advantage.
- Good Practice auditor certifications from reputable certifying agencies are preferred.
- Experience with corrective and preventive action systems is desirable.
About the company
Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.
Company Size
10,001+
Company Stage
IPO
Headquarters
Paris, France
Founded
1973
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Simplify's Take
What believers are saying
- July 10, 2026 FDA approval of Sarclisa Escena created the first on-body cancer injector.
- June 13, 2026 FDA accelerated approval expanded Tzield into recently diagnosed stage 3 T1D.
- Q2 2026 sales grew 17.8% at CER, with Dupixent and Beyfortus leading.
What critics are saying
- Texas sued Sanofi on February 19, 2026 over provider bribery and Medicaid fraud.
- Sanofi sued Pfizer and Moderna on July 15, 2026, extending costly mRNA patent warfare.
- Dupixent concentration makes 2030s patent loss an existential revenue shock.
What makes Sanofi unique
- Dupixent reached €5.2 billion quarterly sales in Q2 2026 across nine indications.
- October 1, 2026, Sanofi and Regeneron added four long-acting antibodies to their Alliance.
- Sanofi's 61-project pipeline spans immunology, rare diseases, vaccines, neurology, and oncology.
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Benefits
Health Insurance
Professional Development Budget
Parental Leave
Company News
France's Sanofi and US-based Regeneron Pharmaceuticals will expand their 20-year partnership to jointly develop and market immunology medicines in a deal worth up to $8 billion. Regeneron will receive $1 billion upfront, with potential additional payments of up to $7 billion tied to development, regulatory, and commercial targets. The collaboration will add four next-generation immunology drug candidates invented by Regeneron, with one currently in early-stage trials for eczema. The companies will equally share development costs and future profits from new drugs, whilst their existing profit-sharing agreement for top-selling medicine Dupixent remains unchanged. The deal settles prior litigation between the companies and marks an early move by Sanofi's new chief executive Belen Garijo to strengthen the company's pipeline.
Sanofi completes acquisition of Vicebio Paris, December 4, 2025. Sanofi announces the completion of its acquisition of Vicebio Ltd (“Vicebio”). This acquisition brings an early-stage combination...
Sanofi completes acquisition of Blueprint Medicines Paris, July 18, 2025. Sanofi today announces the completion of its acquisition of Blueprint Medicines Corporation (Blueprint), adding to its...
Sanofi completes the acquisition of Dynavax Paris, February 10, 2026. Sanofi today announced that it has completed the acquisition of Dynavax Technologies Corporation (Dynavax). The acquisition...
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