Director / Quality / Pharma

Job Description:-

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.