QA Interim

Responsibilities:

• Excellent employment opportunity for a QA Interim Manager in the Fremont, CA area.
• Plan and manage the work of the Quality Assurance group overseeing Quality Control
• Provide technical expertise on Quality Assurance standards
• Identify deviations from SOPs in Quality Control operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolution.
• Supports QA Disposition by review and approval of QC disposition elements (test record reviews, CofA approval, CofC, EM assessments etc.)
• Review and approval of QC Standard Operating Procedures and Change Controls to ensure compliance with cGMP requirements.
• Review and approval of method transfers, method qualifications and QC protocols.
• Oversight and approval of OOX investigations.
• Support Data Integrity initiatives at the site.
• Proposes and executes process and procedural changes to improve QA process performance, robustness, and efficiency.
• This may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition).
• Understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating.
• Key functions are Manufacturing, E&T, Process Science, and Quality.
• Exposure to and dialogue with various colleagues and customers within company, particularly in the quality and manufacturing functions.

• Requires a Bachelors degree with plus 5 years Quality experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility with a minimum of 3 years experience managing/directing people.
• Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• Overall understanding of Quality Assurance specifications and process
• In-depth understanding of QC/Pharma Business
• Strong team leadership skills
• Ability to communicate in an open, customer-focused manner.
• Proficiency with MS Office products (specifically Word, Outlook, Powerpoint and Excel).