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.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. 

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

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, quality agreement, the registered dossier, and Company global quality documents when applicable.

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 establishing trust with the CMOs / third party /supplier business partners and providing quality oversight and support for quality operations activities. The QUALITY LEAD, EM CHC ASEA & AU shall escalate activities, issues, progress to Head of Quality, EM CHC AMEA & China.

The QUALITY LEAD, EM CHC ASEA & AU shall assist in the establishment and continuous development of a robust Quality System of an appropriate standard and shall lead the key areas of Quality Assurance as applicable for the EM CHC AMEA – ASEA & AU entity in collaboration with the Quality Excellence Manager, EM CHC AMEA & China.

The QUALITY LEAD, EM CHC ASEA & AU will plan, organise and coordinate their workload and that of their Quality team members within the EM CHC ASEA & AU hub, so as to ensure that all routine scheduled work is carried out in a cost-effective and timely manner to GxP and regulatory guidelines and to Company procedures. The QUALITY LEAD, EM CHC ASEA & AU will have responsibility to ensure that their EM CHC ASEA & AU hub meets Quality Key Performance Indicators, in line with Organisational and Regulatory Standards and will take part in Quality and Regulatory Audits if required.

The QUALITY LEAD, EM CHC ASEA & AU shall 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. The QUALITY LEAD, EM CHC ASEA & AU shall facilitate the empowerment of the EM CHC ASEA & AU hub Quality team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence of the Quality Documentation, Quality Systems Management and Quality Technical Support.

The QUALITY LEAD, EM CHC ASEA & AU will collaborate across the full EM CHC AMEA & China entity to assist and support leadership and Quality workload as required to drive 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 and request / allocate / perform the GxP audits per plan.
• 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.
• 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.
• Management and support of product recall and return associated with EM CHC ASEA & AU.
• EM CHC ASEA & AU Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
• 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.
• Product Quality Review (PQR) evaluation of the PQR’s issued by CMOs for products managed by EM CHC ASEA & AU.
• Manage Quality aspects associated with termination activities with third-party manufacturers.
• Monitors and reports Quality KPIs. (Complaints, PQR, audit adherence to plan).
• Management of Quality Monitoring and Quality Review.
• Coordinate and participate in quality monitoring and quality review of third-party manufacturers.
• Coordinate and Perform risk ranking of third-party manufacturers.

2.  Quality Operations of EM CHC ASEA & AU Entity

• 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 and in collaboration with the Quality teams in full EM CHC AMEA & China entity, in line with Organisational, Global Quality, Regulatory Standards and Industry Best Practice.
• Manage the Quality documentation system, documentation retention, archival and destruction within the EM CHC ASEA & AU entity.
• Ensures the QMS processes and Quality documents understanding and appropriate execution by organization related personnel within EM CHC ASEA & AU entity.
• Ensures their appropriate evolution with regulations and business needs.
• 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.
• Manage and facilitate the empowerment of the EM CHC ASEA & AU hub Quality managers / team members for operational quality decision making, without compromising the Quality System &/or Standards through implementation and adherence to and alignment with the Quality Documentation, Quality Systems Management and Quality Technical Support.
• Manage and support the Quality Risk management in case of major / critical quality issue originating from third party manufacturers and raised by EM CHC ASEA & AU.
• Coordinate and participate in quality risk meetings and prepare rapid quality notifications if required.
• Quality business process owner for the EM CHC ASEA & AU entity to manage and collaborate on new requirements, new Quality System projects (as example new computerised systems), gaps to existing and procedural updates.
• Collect, consolidate, and prepare the quality KPI’s (Key Performance Indicators) for EM CHC ASEA & AU entity Monthly Quality Reports for reporting to regional Quality and EM CHC AMEA.

3. Quality Training

• Manage the electronic Learning Management system to support EM CHC ASEA & AU hub in conjunction with EM CHC AMEA Quality Excellence Manager
• Defines the GxP related personnel training curricula, and monitors execution of the GxP annual training plan, consolidation of training needs, development of training materials for the EM CHC ASEA & AU entity.
• Tracks compliance of the quality personnel (if applicable) and other applicable personnel members within the EM CHC ASEA & AU hub to their curricula. Ensures that training records are archived as per GxP regulation.
• Contributes to the EM CHC AMEA Awareness on GxP regulation and Quality requirements with respect to EM CHC ASEA & AU.

4. Quality Technical Support

• Contribute to the cross-functional working relationships of the team by participating in interactions between the EM CHC ASEA & AU Quality team and key stakeholders including, Innovation, External contractors and third-parties, Health & Safety, R&D, Regulatory CMC etc.
• Assist in investigations, reviews, management, and co-ordination of Quality Systems within the EM CHC ASEA & AU entity and provide quality oversight and support to third party manufacturers.
• Provide Technical advice and expertise with respect to product, CMO and quality system compliance.
• Manage and monitor completion to target of Annual Product Quality Review program across the EM CHC ASEA & AU entity.
• Manage and monitor the Change Control process for the EM CHC ASEA & AU hub, with associated filing in line with regulatory standards and organisational requirements if required.
• Manage the review of technical reports e.g. stability reports, process /process validation, transport qualification reports etc.  
• Manage the collection, review and update of the Quality and Safety of Material and Product (QSMP) questionnaire and information from the third parties managed by the EM CHC ASEA & AU entity.
• Provide Quality support for transversal projects e.g. new product launch, site transfer or repatriation etc. as required
• Any Ad Hoc activities as specified by the Reporting Manager