Director of Quality Assurance

Team: Quality Assurance

Location: Alameda, CA

Commitment: Full-time

Workplace Type: onsite

Responsibilities:

• Leading the implementation and monitoring of manufacturing and analytical processes in compliance with GMP, ensuring a state of operational control.
• Overseeing deviation and CAPA management systems, ensuring comprehensive investigations, effective corrective actions, and timely resolution.
• Managing the efficient review of GMP documentation and timely lot disposition to support compliant product release for both commercial and clinical products.
• Providing leadership for QA decision-making and serving as the primary escalation point for significant quality issues across the organization.
• Establishing and monitoring Quality key performance indicators, driving continuous improvement and maintaining readiness for regulatory inspections.
• Building strong partnerships with key stakeholders, including Site Leadership, Facility, Manufacturing, and Quality teams, to achieve strategic quality objectives.
• Championing a positive safety culture and promoting adherence to Safety, Health, and Environment (SHE) requirements aligned with corporate and local regulations.
• Providing support and oversight for meetings focused on reviewing and assessing open gaps, while collaborating with cross-functional teams to mitigate potential risks.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Remain current on Regulatory Intelligence, new guidance documents and competitive information to provide comprehensive information to program teams.
• Responsible for the implementation and reporting on the performance of the Quality Management System to the executive management team.
• Establishes or administers an organizational quality management system and monitors progress against strategic quality-related goals.
• Performs other duties as assigned.

Qualifications:

• Minimum of a bachelor’s degree, preferably in a scientific discipline.
• A minimum of 15 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management within the pharmaceutical or biotechnology industry is a must, including 10 years of experience in management/leadership roles.
• 10+ years in a QA management role.
• Minimum of 10 years of GMP experience.
• 12-15 years of QA related experience required.
• General knowledge of aseptic manufacturing processes.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience organizing and managing work responsibilities while working independently with minimal oversight.
• Time and project management skills with the ability to multi-task and meet deadlines.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills. 
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Deep knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs.
• Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA authorities.
• Experience with drug substances and drug products is desired.
• Knowledge of regulatory requirements across development stages and post-approval is essential.
• Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.
• Strong strategic and analytical abilities, diplomacy, and negotiation skills.
• The ability to collaboratively influences multiple functions and motivates others to accomplish company objectives.
• Ability to work flexibly within tight timelines and with strong project management skills.
• Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.