Senior Director, Quality Operations

Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history

We are seeking a highly motivated individual to join as Sr. Director of Quality Operations South San Francisco location. The successful candidate will lead a team of quality professionals to ensure continuous product supply through event management (Deviations, Change Control, CAPA), global product disposition, and ongoing Quality oversight of all external (conducted by contract manufacturing organizations and laboratories) GMP activities, including but not limited to cell banking operations, drug substance and drug product manufacturing, labeling and kitting operations for clinical trials, release and stability testing and all related process and method validations.The position is an important leadership role but will also require “hands-on” work and the ability and readiness to be working.

Responsibilities:

• Lead a team of Quality professionals to establish an effective Quality Operations department in a fast-paced, late-stage biotech company.
• Oversee global product disposition of drug substances, products, and clinical kits, coordinating with Qualified Persons in Europe and other regions for timely release.
• Manage Quality Events (Deviations, CAPAs, Change Control, Complaints).
• Provide Quality production oversight across the supply chain, coordinating with CMOs and internal collaborators, and prioritize external audits with the Quality Systems and Compliance team.
• Oversee analytical method development, validation, specification setting, and stability programs.
• Participate in Quality System and SOP development for Quality operations.
• Engage in internal Quality activities such as audits, inspection readiness, and electronic system implementation.
• Perform additional tasks as directed by the VP of Quality.
• Collaborate with internal Quality teams (Clinical Quality, Quality Systems) and external Quality teams at CMOs or partner companies.
• Work closely with internal partners, including Operations teams and Regulatory Affairs.

Requirements:

• Bachelor's degree in biological sciences or related field with 12+ years in pharmaceuticals, including 6+ years in Quality. Advanced degree preferred.
• 6+ years' experience with biological products, especially recombinant proteins or monoclonal antibodies, and knowledge of upstream/downstream processes and aseptic filling.
• Experience leading and developing a team of quality professionals.
• In-depth knowledge of method development, validation, and testing for Biologicals.
• Strong understanding of US and international GMPs (e.g., ICH Q1 – Q12) for late-stage clinical and commercial environments.
• Proficient in Quality Risk Management, data integrity, and validation concepts.
• Knowledge of cell banking operations.
• Basic understanding of Clinical Quality principles.
• Experience with GMP inspections by FDA and other Health Authorities.
• Effective communication and decision-making skills in Quality.
• Strong interpersonal skills for cross-functional and cross-company teamwork.
• Ability to multi-task and prioritize systematically.