QA Ops & Batch Release Lead

Job Information

Job title: QA Ops & Batch Release Lead

• Location: Shenzhen, China

• % Remote working and % of travel expected: N/A

• Job type: Full time

• Site/Unit: Beijing Site/ M&S China

About the job

Our Team:

The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.

About Our Team:

As a globally leading innovative biopharmaceutical company, Sanofi's Shenzhen site focuses on the end-to-end manufacturing of influenza vaccines and local packaging of imported vaccines, serving the Chinese market. The site is located at Sanofi Life Sciences Park, No. 25 Jinxiu East Road, Pingshan District, Shenzhen.

Our Quality Operations (QA Ops) and PCU team upholds Sanofi's "Take the Lead" values and serves as a core pillar of quality and operational excellence at the site:

• Aim Higher – We focus on the most critical quality objectives, set high standards, and drive our work with a sense of urgency, learning from setbacks to achieve higher performance.

• Act for Patients – We never compromise on integrity, remove obstacles, and collaborate with others to go further and faster for patients.

• Be Bold – We take calculated risks, seize opportunities, and push beyond the boundaries of what is possible to accelerate our scientific progress.

• Lead Together – We build trust, collaborate openly around shared goals, celebrate collective wins, and foster a sense of belonging.

The team is committed to excellence in quality management. Through core functions including release management, Product Quality Review (PQR), and manufacturing quality operations, we ensure the continuous and robust operation of the quality system — living out the mission of "Chasing the miracles of science to improve people's lives."

Main responsibilities:

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations

• Conducting regular audits of production processes to identify and address potential quality issues

• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor

• Managing and resolving quality-related issues in a timely and effective manner

• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed

• Leading root cause analysis investigations for quality incidents and implementing preventive measures

• Participating in internal and external audits and regulatory inspections providing support and documentation

• Developing and implementing risk management strategies to mitigate potential quality issues

• Fostering a culture of quality and continuous improvement across the organization

• Overseeing the batch release process to ensure compliance with regulatory requirements and company standards

• Overseeing review and approval of batch records and associated documentation

• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

• Conducting risk assessments and implementing mitigation strategies for batch release processes

• Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities

• Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)

• Participating in internal and external audits and inspections

• Collaborating with regulatory affairs to ensure compliance with local and international regulations

• Monitoring and analyzing batch release performance metrics

• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness

• Attend quality alert/product alert meetings and ensure that investigations and actions taken during these meetings determine the handling of the batch.

• Represent the factory in the globally leading CoP, participate in the CoE if required, and ensure local communication.

• The contact person within the operations team who needs to conduct on-site complaint investigations (to coordinate investigation reports).

Key Roles (Decide/D, Advise/A, Inform/I)

• Request corrections when GMP rules are not respected (D)

• Prioritize quality and compliance objectives (A)

• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)

• Request quality improvement initiatives and strategies (D)

• Identify discrepancies and corrective/preventive actions that need to be taken (D)

• Escalate to upper management any failure in GMP execution on shopfloor (I)

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)

• Advise on how to present a topic and answer specific questions (A)

• Advise on risk management strategies and plans (A)

• Advise on initiatives to promote a quality-focused culture (A)

• Approve documentation for batch disposition and update corresponding digital tool to allow release (D)

• Implement risk mitigation strategies to address potential quality issues in the batch release process (D)

• Resolve issues and deviations and take disposition decision on lots (D)

• Analyze performance metrics and escalate in case of issues (I)

• Informing senior management about batch release performance metrics and trends to support data-driven decision-making (I)

• Approve actions taken during Quality Alert meeting (D)

• Advise on complaint investigation (A)

Other responsibilities

• Perform other duties assigned by leader

About you:

Expected Experience

• Minimum of 2 years experience in quality assurance within the pharmaceutical industry

• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Expected Technical skills

• Ability to analyze complex data and identify trends, issues, and solutions

• High level of accuracy and attention to detail in all quality assurance activities

• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

• Proficiency in identifying problems and implementing effective corrective action

• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Language

• Local language and English

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !