Batch Release Lead

Sanofi Group; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Sanofi Singapore seeks a Batch Release Lead to provide QA oversight for final drug substance disposition, batch release, deviations, change controls and Product Quality Review activities. You will collaborate with Manufacturing, Quality, Regulatory and site stakeholders to ensure GMP-compliant disposition decisions and continuous improvement.

The role requires strong experience in GMP, QA processes, and deviation investigations, with the ability to manage investigations and coordinate with

Qualifications

• At least 5 years of Quality Assurance experience in the pharmaceutical industry.
• Strong understanding of GMP and QA principles.
• Experience supporting investigations, change controls and other QA systems.
• Ability to investigate, assess and resolve quality issues or deviations.

Responsibilities

• Batch Disposition & Release: Perform final drug substance disposition for release to customers and ensure all requirements are complete before disposition.
• Deviation & Investigation Management: Act as QA reviewer for site deviations and support root cause analyses.
• Quality Systems & Compliance: Review and approve change controls; perform Product Quality Reviews and ensure regulatory alignment.
• Continuous Improvement: Identify opportunities to strengthen deviation investigations and QA processes.
• Audits & Inspections: Support internal and external audits and regulatory inspections; assist with inspection readiness.

Skills

Quality Assurance

GMP Knowledge

Deviation Investigations

Change Control

Job description

About the Role

The Batch Release Lead is responsible for providing Quality Assurance oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review activities. The role works closely with Manufacturing, Quality, Regulatory and other site stakeholders to ensure products are appropriately assessed and dispositioned in accordance with Good Manufacturing Practices (GMP), site quality requirements and applicable regulatory standards. The incumbent will also support quality investigations, audits and continuous improvement initiatives to strengthen site quality systems and operational effectiveness.

Key Responsibilities

• Batch Disposition & Release
  • Perform final drug substance disposition for release to secondary customers.
  • Review batch-related quality information and ensure all requirements are satisfactorily completed prior to disposition.
  • Investigate and resolve issues or deviations impacting batch release.
  • Ensure all batch release and disposition activities are performed in compliance with GMP and applicable quality requirements.
  • Participate in Quality Alert/Product Alert meetings, ensuring investigations and associated actions provide sufficient information to support lot disposition decisions.
• Deviation & Investigation Management
  • Act as the QA reviewer for site deviations, ensuring investigations are comprehensive, scientifically sound and completed in a timely manner.
  • Lead and/or support root cause analysis investigations for quality incidents and ensure appropriate corrective and preventive measures are identified.
  • Review investigation outcomes and assess potential impact to product quality and batch disposition.
  • Serve as the operational Quality point of contact for complaint investigations requiring site support, including coordination of investigation reports.
• Quality Systems & Compliance
  • Review, assess and approve site change controls, ensuring potential quality and regulatory impacts are appropriately evaluated.
  • Perform Product Quality Reviews (PQR) in accordance with site and regulatory requirements.
  • Collaborate with the Regulatory Support Officer to ensure compliance with applicable local and international regulatory requirements.
  • Ensure activities are performed in accordance with GMP, site procedures and established Quality Assurance principles.
• Continuous Improvement
  • Identify and implement continuous improvement initiatives to strengthen deviation investigation processes, progress monitoring and overall effectiveness.
  • Review performance metrics and trends to identify opportunities for improvement.
  • Support improvements to Quality systems and operational processes while maintaining regulatory compliance.
• Audits & Inspections
  • Participate in internal and external audits and regulatory inspections.
  • Support inspection readiness activities and provide Quality documentation and subject matter support as required.
  • Support follow-up and closure of observations and associated actions where applicable.

Skills & Experience

Experience At least 5 years of Quality Assurance experience within the pharmaceutical industry, with a strong focus on deviation management and batch release/disposition processes. Strong knowledge and practical understanding of Good Manufacturing Practices (GMP) and Quality Assurance principles. Experience supporting quality investigations, change controls and other pharmaceutical Quality systems.

Skills Strong capability to investigate, assess and resolve quality issues or deviations efficiently. Good analytical and problem-solving skills, including experience with root cause analysis. Ability to analyse performance metrics and trends and identify areas for improvement. Strong organisational and project management skills, with the ability to manage multiple priorities and activities simultaneously. Effective cross-functional communication and stakeholder management skills. Ability to operate effectively in an ambiguous, dynamic and fast-changing environment. Strong attention to detail with a commitment to quality, compliance and timely execution. 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 sanofi.com! We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.