QA OPS Manager B79 Viral PCU Lead

Job Title: QA OPS Manager B79 Viral PCU Lead

• Location:
  
  Swiftwater, PA

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as QA OPS Manager – B79 Viral PCU Lead within our Quality Assurance team, will be to lead and drive quality over the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

This role provides leadership and direction for quality oversight of the vaccine drug product manufacturing. This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high-quality life-saving vaccines. The QA OPS Manager
-B79 Viral PCU Lead will lead a team of quality professionals overseeing the B79 Viral Manufacturing, B78 Seed Facility and QC Facility.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

• Ensuring that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and product permissions are maintained
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Overseeing the daily operations of the quality assurance team assigned, ensuring all activities align with company goals and regulatory requirements
• Ensuring the timely closure of quality events such as deviations, CAPAs, PQR, and change controls to maintain compliance and operational efficiency
• Overseeing all the investigations product-related (eg deviation, OOx) in their scope to ensure they are properly conducted, allowing appropriate risk assessment and product impact assessment
• Conducting regular audits of production processes to identify and address potential quality issues
• Collaborating with production to ensure quality standards are maintained throughout the product lifecycle
• Managing and resolving quality-related issues in a timely and effective manner
• Training and managing quality assurance operational team
• 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 record review process for area within their scope, ensure compliance with regulatory requirements and company standards
• Reviewing and approving batch records and associated documentation
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

• Establish and prioritize quality and compliance objectives for the site (D)
• Ensure the implementation and maintenance of robust quality…