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.

Key Responsibilities:

1. Manage the Quality Due diligence, evaluation, selection, and approval of third-party Contract manufacturers (CMO).
2. Provide Quality oversight and quality support to Company entities managing third party manufacturers in this region.
3. Manage the third-party audit plan for the EM CHC ASEA & AU hub and request / allocate / perform the GxP audits per plan.
4. Manage the review, discussion, and follow-up of CAPAs related to audits performed and to the ongoing management of products manufactured by the third-party for the Company.
5. EM CHC ASEA & AU Complaints management with review of complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend and initiating CAPA where required.
6. Management and support of product recall and return associated with EM CHC ASEA & AU.
7. EM CHC ASEA & AU Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
8. EM CHC ASEA & AU Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
9. Product Quality Review (PQR) evaluation of the PQR’s issued by CMOs for products managed by EM CHC ASEA & AU.
10. Manage Quality aspects associated with termination activities with third-party manufacturers.
11. Monitors and reports Quality KPIs. (Complaints, PQR, audit adherence to plan).
12. Management of Quality Monitoring and Quality Review.
13. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.
14. Coordinate and Perform risk ranking of third-party manufacturers.

Quality Operations of EM CHC ASEA & AU Entity:

1. Manage and participate in continuous improvement / development of quality systems on an ongoing basis and assist in investigations, reviews, management, and co-ordination of Quality Systems and processes within the EM CHC ASEA & AU entity.
2. Manage the Quality documentation system, documentation retention, archival and destruction within the EM CHC ASEA & AU entity.
3. Ensure appropriate evolution of QMS processes and Quality documents with regulations and business needs.
4. Participate in and manage the Quality observations and Self-inspection program for the EM CHC ASEA & AU hub with a key focus on continuous improvement and efficient compliance.
5. Manage and support the Quality Risk management in case of major / critical quality issue originating from third party manufacturers.

Quality Training:

1. Manage the electronic Learning Management system to support EM CHC ASEA & AU hub.
2. Define the GxP related personnel training curricula, and monitor execution of the GxP annual training plan.
3. Track compliance of the quality personnel and other applicable personnel members within the EM CHC ASEA & AU hub to their curricula.

Quality Technical Support:

1. Contribute to cross-functional working relationships of the team by participating in interactions between the EM CHC ASEA & AU Quality team and key stakeholders.
2. Assist in investigations, reviews, management, and co-ordination of Quality Systems within the EM CHC ASEA & AU entity.
3. Provide Quality support for transversal projects as required.

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.