Manager, QA GMDP

Celere, Inc.
San Francisco, CA
Jul 29, 2017
Jobs Outside Higher Education
Businesses & Consultants
Institution Type
Outside Academe

Job Description
  • Compile, organize and file quality records and documentation which include, but not limited to, executed batch record documentation, manufacturing records, labeling and packaging records, and associated documentation
  • Assist with GMDP vendor management activities with respect to product manufacture and release
  • QA contact or SME to facilitate (manage) Change Controls and Non-Conformance/CAPA reports within Medivation and CMOs
  • Develop and revise Standard Operating Procedures, Work Instructions and Forms
  • Provide support with authoring of Quality Agreements with CMOs
  • Ensure compliance of the CMO operations with applicable regulations and Quality Agreements
  • Ensure product compliance with IMPD, specifications or monographs, as applicable
  • Manage quality event at the CMO including troubleshooting activities associated with product manufacturing and release
  • Manage the Change Control process related to product manufacturing process
  • Establish and maintain Quality Indices related to manufacturing, data gathering and processing mechanisms to define and monitor process capabilities
  • Perform appropriate statistical evaluation of process data and drive process quality improvement efforts using appropriate statistical tools and techniques
  • Assist with intra-departmental quality improvement teams to prioritize projects and achieve process capability improvement goals
  • Support product transfers and/or launches at CMO as per Medivation strategy
  • Support the preparation and review of process validation protocols and reports and any related activities
  • Manage multiple priorities, follow release schedules and meet deadlines
  • Other duties as assigned
  • Must have a minimum of 6 years' small molecule/biopharmaceutical experience that fall under CDER regulation. Minimum of 4+ years of management experience. Experience with leading audits, certification preferable.

San Francisco, CA


Fri, 28 Jul 2017 00:28:42 PDT