Quality Lead, EM CHC ASEA & AU

Quality Lead, EM CHC ASEA & AU

Position: Quality Lead, EM CHC ASEA & AU

Reporting to: Head of Quality, External Manufacturing CHC AMEA & China

Location: Singapore

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

Join us on our mission. Health. In your hands.

The QUALITY LEAD, EM CHC ASEA & AU shall manage the quality and compliance oversight of Contract Manufacturing Organisations (CMOs), third-party manufacturers and suppliers within the EM CHC ASEA & AU entity according to the GxP requirements, international, and Company global quality requirements.

The QUALITY LEAD, EM CHC ASEA & AU shall serve as the functional quality representative and ensure that CMOs / third party /suppliers are approved and that contracted Good Manufacturing Practices (GMP) activities are in compliance with international and local regulatory requirements.

The QUALITY LEAD, EM CHC ASEA & AU shall ensure regular monitoring, assessment of records and results related to the contracted GMP activities. The QUALITY LEAD, EM CHC ASEA & AU shall contribute to business operation by establishing partnerships and providing quality oversight and support for quality operations activities.

The QUALITY LEAD, EM CHC ASEA & AU shall assist in the establishment and continuous development of a robust Quality System and shall lead the key areas of Quality Assurance.

The QUALITY LEAD, EM CHC ASEA & AU will plan, organise and coordinate their workload and that of their Quality team members to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines.

The QUALITY LEAD, EM CHC ASEA & AU shall participate in and manage the Quality observations and Self-inspection program with a key focus on continuous improvement and efficient compliance.

Key Priorities:

1. Quality Management of third-party manufacturers and suppliers:
   • Manage the Quality Due diligence, evaluation, selection, and approval of third-party Contract manufacturers (CMO).
   • Provide Quality oversight and quality support to Company entities managing third-party manufacturers in this region.
   • Manage the third-party audit plan for the EM CHC ASEA & AU hub.
   • Manage the review, discussion, and follow-up of CAPAs related to audits performed.
   • EM CHC ASEA & AU Complaints management and monitoring of complaints trend.
   • Management and support of product recall and return associated with EM CHC ASEA & AU.
   • EM CHC ASEA & AU Change control management.
   • EM CHC ASEA & AU Deviation management and out-of-specification investigation.
   • Product Quality Review (PQR) evaluation of the PQR’s issued by CMOs.
   • Manage Quality aspects associated with termination activities with third-party manufacturers.
2. Quality Operations of EM CHC ASEA & AU Entity:
   • Manage and participate in continuous improvement of quality systems.
   • Manage the Quality documentation system within the EM CHC ASEA & AU entity.
   • Participate in and manage the Quality observations and Self-inspection program.
3. Quality Training:
   • Manage the electronic Learning Management system.
   • Defines the GxP related personnel training curricula.
4. Quality Technical Support:
   • Contribute to the cross-functional working relationships of the team.
   • Provide Technical advice and expertise with respect to product, CMO and quality system compliance.

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.