Director - Quality - Pharma

Executive Hiring, a Leadership Search Orgn. is looking for a Director - Quality for a Large MNC Pharma organisation, based at Mumbai.

- Bachelor's Degree in Biology or Similar is Required. Advanced degree (MS, MBA) is preferred.

- A minimum of 15 years in Pharmaceutical/Medical Device/Biotech is required. Experience in drugs, biologic are essential to success.

- Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required. Experience in presenting issues to all levels of the organization is required.

The KRA's

- Heading all of the Quality and Compliance activities of External Manufacturing in the APAC Region and provide the proper interface to External Supply Integration and JSC Internal Manufacturing.

- Act as senior level interface to key Health Authorities in the region for all of JSC External Manufacturing.

- Interface with the Product Management and Customer Management teams to supply the markets.

- Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time

- Monitor trends, identify issues, recommend and implement appropriate actions.

- Provide cGMP compliance support to External Manufacturers by investigating and resolving quality issues.

- Coordinate and provide concurrences on deviations, change controls and CAPAs.

- Travel to External Manufacturer's sites to provide cGMP assistance and quality oversight.

- Develop, implement, and review of SOPs for interactions with External Manufacturers.

- Investigate customer product quality complaints.

- Apply cGMP regulations and other Health Authority and international requirements to all aspects of the position.

- Coordinate change control documentation and approval process.

- Provide Quality oversight and participate on technical transfer teams.

In case this of interest to you, please forward your detailed resume mentioning CTC

For any other further clarity, please feel free to reach out to Sanjoy @ + 91 9046968619.