Friday, March 10, 2017

Global Head Compliance Management Sanofi Bridgewater

Job Description: • 2-minute read •
This role has responsibility to define, develop and maintain the Sanofi Pasteur cGMP compliance and quality performance strategy as well as monitoring progress and lead key activities to ensure the company meets the highest quality standards relevant to our business. He or she will also ensure that relevant information and best practices are shared globally and that a continuous improvement towards sustainable practice is established for achieving quality and compliant business. This role also includes active involvement external to Sanofi Pasteur to advocate the company’s view on cGMP compliance and quality performance as it relates to vaccines.
Key Accountabilities:


Provide leadership and direction to sites in order to ensure that cGMP compliance activities are understood, prioritized and managed. Ensure strategic compliance through global initiatives and projects, build sustainable compliance processes.
Ensure cGMP compliance through leadership for the implementation of the Sanofi Quality System (through clear dialog and clear business processes), setting and monitoring key quality and cGMP compliance metrics and act on these where needed, and through active engagement with other Quality leaders and functions in Sanofi Pasteur and Sanofi.

Ensure robust inspection management programs are in place at all sites and provide leadership and coordination for company-wide activities. Responsible for independent compliance assessment of IO and R&D clinical batch manufacturing with Global Quality Directives and Health Authority expectations according to the PMG process.

Manage any 3rd party used to support the cGMP compliance activities. Ensure Drug Shortage Prevention Plans are established per company guidelines and priorities.

Provide leadership with regards to risk management, escalation & management of critical events and risks globally as well as maintaining emerging risk surveillance.

Ensure continuous improvement of material management and efficiency of supply management and supply chain quality.

Own the Corporate Quality Council business process and the Quality Management Review process.

Build Quality Intelligence and Knowledge Management processes for Sanofi Pasteur and develop network with Sanofi.

Work closely with the Responsible Pharmacist organization in all matters related to cGMP compliance and quality performance.

External involvement to ensure current and future cGMP and quality requirements are influenced and understood.


Qualifications
Basic Qualifications:
Bachelor's degree in Biology, Pharmacy or Microbiology

At least fifteen years direct experience in pharma/biotech manufacturing and quality environments/organizations with a history of success in dealing with or working in major Regulatory Authorities, particularly the EMEA, WHO and the FDA. A good understanding of Regulatory Submissions is also a necessity.

Technical Competencies & Soft Skills:
Fluent in English
Strong ability to lead project with multi-disciplinary and international teams
Strong ability to build and drive a network
Ability to make decisions in a highly moving environment
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