Director Quality Assurance Anacor Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED Position Type: Full time
Position Reports to: VP of Regulatory Affairs and Quality Assurance
Function: Regulatory Affairs and Quality Assurance
Direct QA staff in all aspects of API and drug manufacturing quality control for clinical and future commercial drug products. This includes but is not limited to:
? Review and approval of analytical method validation, technology transfer and method transfer protocols as needed in support of release testing of drug substances and drug products at CMO;
? Review and approval of Master Batch Records (MBR) to comply with good manufacturing practice regulations, regulatory filings and quality agreements;
? Review of executed batch records, Certificates of Analysis and other documents to release drug substance and final drug product for the intended use;
? Review and approval of method, process and specification changes, deviations and OOS/OOT; Oversight of quality control aspects of stability programs for Anacor?s drug product pipeline.
? Provide analysis and trend stability data for management review and prepare reports in support of IND/NDA submissions.
Lead PAI inspections and implement quality systems for commercial launches
Direct the QA staff to provide quality oversight of CMOs for the manufacture and release of commercial API and drug products
Develop, refine and maintain Quality Agreements with CMO?s
Develop, refine and maintain internal quality system procedures to assure GXP compliance; report trends at Management Reviews and lead corrective/preventive actions to assure continuous improvement
Conduct compliance audits of contract service providers; assess the performance of contract service provider?s quality system as part of CMO selection and maintenance
Present and defend quality systems and control documentation during regulatory agency inspections of Anacor and Anacor?s contract service providers
Collaborate with CMC core team to develop and implement manufacturing and regulatory drug substance and drug product specifications
Stay current with industry practices and regulatory updates to provide timely communication of such updates and related trainings to reinforce GXP compliance
Mentor Quality staff to provide professional development and growth opportunities
Provide quality control support to the regulatory group for regulatory submissions
Maintain flexibility to perform other / additional tasks as assigned
Minimum of 15 years of experience in the pharmaceutical industry with 10 years of direct quality assurance/quality control oversight of API and drug development and manufacture of clinical materials and commercial products.
Experience with commercial launch strongly preferred.
Understanding and ability to apply knowledge of GXP, QSR, ISO 13485, and ICH requirements
Experience in the development and maintenance of quality system procedures, Quality Agreements and other key documents to support company?s quality compliance system
Strong planning and time management skills and ability to prioritize work for the department
Strong leadership and interpersonal communication skills to influence a desired outcome
Ability to discuss scientific/technical data with team members
Ability to work in a fast-paced, multi-task team environment
Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline. Advanced degree is preferred.
||Palo Alto, CA |
THIS JOB HAS EXPIRED