Head Quality - External Manufacturing, APAC

About the job

Our Team:

• Collaborate with GQEM Quality Operations for rolling-out best practices and governance for CMO Quality Management within the EM Quality network, ensuring quality oversight and supporting Quality Team of respective perimeter. 
• Promote best practices and governance for CMO Quality Management within the External Manufacturing Quality network. Ensure quality oversight and support EM entities, especially Quality Teams. 
• Lead and coordinate quality and compliance of transversal projects for the EM entities.

Main responsibilities :

• Entities Quality management system

1. Develop and Maintain oversight on the Quality management Systems for EM entities. 

2. Rolling-out best practices and governance for CMO Quality Management within the EM Quality network 

3. Supports EM Quality Heads in defining their priorities in accordance to the annual Global quality roadmap. 

4. Ensure that EM entities are kept informed about any new regulations, new Sanofi requirements. 5. Support EM entities for the GMP audit / inspection readiness. 

Entity Quality Review 

1. Organize the Site Entity quality review meeting in agreement with Quality Team At least once a year. 

2. Prepare the minutes, indicating decisions taken and references of CAPA.

3. Align and Define CAPA with Quality unit for Continuous improvement of quality entities

Management of Risk 

Ensure the Global Quality directives are implemented and established by EM entities for the escalation of Quality events and management of Risk. 

Quality agreement

Ensure and facilitate EM entities for Establishing appropriate Quality agreement between Sanofi and CMO’s and Sanofi affiliates. 

Risk ranking of CMO’s

1. Oversight the risk ranking for CMO’s as per the Sanofi Directive and risk assessment for the Quality issues

• Projects

1. Participate and Contribute for Quality to the Global Project conducted at regional level 

2. Support to Business development projects. Participate and support EM entities for Selection and Approval of CMO Or Due diligences (for acquisition of new products)

• Key Performance Indicators

1. Support the EM entities for global quality KPIs reporting in Square system 

2. Comment the global KPIs To assess the CMO and the quality of the CMO managing Entity performance. 

3. Define and track local additional indicators, if needed In compliance with local EM procedure. 

4. Align and Define CAPA with Quality unit to plan, if applicable In case of significant deviation from target. 

5. Follow the CAPA plan implementation. 

Monthly Report 

1. Issue a monthly report. 

2. Send the monthly report to the GQEM Quality Operations

About you

• Education: M.Sc / M.Pharm / MS / Ph.D / B.Pharm
• Experience: Around 15 years total experience in the Pharmaceutical Industry out of which at least 10 + should be in Quality/ Regulatory Function and rest in one more department like Manufacturing or formulation department.

• Skills
  • Sound Knowledge on Current GMP requirements of local and various international regulatory agencies, Drugs and Cosmetics Act and Rules, Pharmacopoeias and ICH guidelines.
  • Thorough knowledge of Pharmaceutical Technologies, with Scientific Approach and presentation skills.
  • Exposure to regulated , semi regulated markets and experience of handling regulatory audits
  • Skills for Effective communication, networking, interpersonal relations, assertiveness and leadership.
• Languages: English

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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!