Quality Assurance Manager (Small Molecule API)

Location
South San Francisco, California
Posted
Mar 15, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The Portola Quality Assurance Department seeks a Quality Assurance Manager with experience supporting manufacturing operations of small molecule API. Reporting to the Associate Director, QA, the QA Manager will work closely with Manufacturing, Technical Operations, Analytical Development, Quality Control and Clinical Operations personnel providing Quality Assurance oversight of contract manufacturers (CMOs) and for ensuring compliance with all relevant FDA and EU regulations and guidelines. The Quality Assurance Manager has responsibility for day to day quality oversight activities of the CMO manufacturing, including but not limited to, review/disposition of DS, deviation resolution, CAPA, changes, and documentation supporting the suitability of the batch.

  Responsibilities: 

  • Review executed API and stability reports, including applicable analytical data packets
  • Prepare commercial and clinical product lot release and disposition documents
  • Work directly with contract manufacturing, testing laboratories to resolve quality issues and ensure Corrective and Preventive Actions are identified and effectively implemented
  • Provide QA guidance and support for supplier qualification, technology transfer, scale-up, validation and other GMP activities associated with Portola products manufactured by CMOs
  • Review/approve the qualification/validation/transfer/ continued process verification protocols and reports
  • Facilitate resolution of quality issues with internal and external parties in a timely manner
  • Coordinate communications with CMOs and internal team for quality issues
  • Approve and provide quality support of transfer (shipment) of API
  • Support laboratory investigations related to test failures, discrepancies, and deviations
  • Review and approve CMC sections of regulatory filings
  • Assist the Quality Compliance team to conduct CMO audits as an SME or supporting auditor
  • Provide onsite Quality Person-In-Plant (PIP) and onsite client review/release as required
  • Provide leadership of best practice and continuous improvement of the Quality Assurance functions
  • Assist in developing platform solutions anticipating future business needs

 Requirements: 

  • BS or BA degree in Chemistry, Biology or related science field
  • 5-8 years’ experience in Pharmaceutical or biotechnology industry with at least 5 years in QA
  • 2 years’ experience in outsourced manufacturing environment preferred
  • Demonstrated knowledge of cGMP, GLP, ICH and other regulatory requirements for the manufacture and testing of API
  • Biologic drug substance experience is a plus
  • Ability to effectively partner and negotiate with representatives from contract organizations
  • Proven proficiency using MS Word, Excel and PowerPoint
  • Excellent written and oral communication and organization skills
  • Ability to prioritize and manage several projects and activities simultaneously
  • Ability to lead, collaborate, and work independently and in a team environment
  • Ability to handle multiple assignments in a fast-paced environment with varying complexity, changing priorities and timelines
  • Technical leadership in change management, CAPA, and deviation authorship
  • Experience with effectively supporting FDA inspection, working with regulators, and supplier audits
  • Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, design verification and URS
  • In-depth knowledge and full understanding of pharmaceutical GMPs (US and EU)
  • Prior experience related to supporting technology transfer, scale up and validation
  • Must be highly organized
  • Ability to thrive in a small group setting with limited administrative support
  • Experience with Lean management techniques and visual management best practices
  • Highly motivated team player willing to contribute to a growing biopharmaceutical company
  • 10 to 15% travel (domestic and international)