Associate Director Quality Assurance Anacor Pharmaceuticals, Inc.
The ideal AD, Quality Assurance candidate is a technical savvy quality professional with prior management experience. This position is responsible for a number of key quality systems and close oversight of CMOs. The job requires up to 10% travel, excellent interpersonal and organizational skills.
Manage review and approval of analytical method validation protocols and support the quality aspects of method transfer for use in release testing and stability of drug substances and drug products at CMO.
Manage review and approval of Master Batch Record (MBR) to comply with good manufacturing practice regulations, regulatory filings and quality agreements.
Manage review of executed batch records, Certificates of Analysis and other documents, i.e. deviations and OOS/OOT to release drug substance and final drug product for the intended use.
Manage review and approve changes to methods, processes and specifications for all Anacor programs.
Review and approve stability reports for Anacor?s drug product pipeline. Analyze and trend stability data for management review and prepare reports in support of IND/NDA submissions.
Perform external audits of CMO and contract test laboratories for GMP products and CROs for GLP, non clinical and PK/PD studies.
Collaborate with CMC core team to develop and implement manufacturing and regulatory drug substance and drug product specifications.
Collaborate with cross-functional project teams to provide guidance on quality assurance matters.
Provide ad-hoc support to the regulatory group on regulatory submissions, as required.
BS, MS or above degree in a science or life science discipline required
Minimum of 10 years of experience in the pharmaceutical industry in the areas of drug development and manufacture of clinical materials and commercial products with 10 years of direct experience in the quality assurance/quality control area.
In-depth practical knowledge of GMP and ICH requirements and applications.
Excellent written and oral communication and organizational skills.
Ability to discuss scientific/technical data with team members.
Ability to work in a fast-pace, multi-task team driven environment.
Prior experience with supplier audits is required.
Prior supervisory experience is a plus.
Proficient in navigating through various web based electronic systems
Proficient in use of Microsoft Office applications
||Palo Alto, CA |