Associate GCP/GLP QA Director

Summary This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. It provides insight and partners with GCP QA staff and Clinical Operations Quality Management to address day‑to‑day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. The role operates across all clinical project teams and provides training with inspection readiness activities as required. Key Responsibilities Design and coordinate a comprehensive view and align standards on quality systems across Clinical QA. Assess current state, identify gaps, develop an action plan, implement improvements, and monitor quality systems and internal processes related to GCP QA activities. Develop, track, and manage periodic management reports focused on track and trend data for key clinical and QA metrics. Review and approve deviations and corrective and preventive actions (CAPAs). Partner with regulatory affairs, clinical operations, and translational medicine to address compliance issues and provide guidance. Maintain knowledge of current Health Authority regulations and standards and inform stakeholders of potential impact. Represent CQA in internal presentations on quality issues, initiatives, and projects. Identify issues and risks, propose options and solutions, and elevate risks in a timely manner. Participate in identifying and implementing process and system improvements. Qualifications & Experience Bachelor's degree in science (biology, chemistry, pharmacy, medical, mathematics, engineering) with a minimum of 11 years relevant experience; or Master’s degree with a minimum of 9 years relevant experience; or PhD with a minimum of 5 years relevant experience; or an equivalent combination of education and experience. Minimum of 10 years relevant experience in the pharmaceutical and biotech industries. Experience in Good Clinical Practices. Demonstrated experience in quality systems, including critical analysis and continuous improvement processes. Strong understanding of quality risk management. Experience using standard MS Office. Knowledge & Skills Understanding of the drug development process, particularly related to QA oversight of clinical trials. Experience assisting in the development of business strategies, metrics, and continuous improvements. Working knowledge of Health Authority rules and regulations. Proven ability to manage quality systems, assuring completeness and acceptability as defined for GCP. Ability to apply quality risk management in a variety of situations across quality systems. Ability to influence others as part of a collaborative team and negotiate effective solutions. Strong interpersonal and social skills. Meticulous in execution of tasks and processes. Excellent verbal and written communication skills. Exercises judgment within defined procedures and practices to determine appropriate action. Provides insight and analysis of situations or data requiring review of a variety of factors. Working Conditions Primarily working in laboratories or in the office. Infrequent travel may be required. Compensation and Benefits Base salary range: $177,500 – $251,500 annually. Benefits include a 401(k) plan with generous company contributions; group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; discretionary annual bonus; stock purchase options; long‑term incentives; 15 accrued vacation days in the first year; 17 paid holidays, including a company‑wide winter shutdown in December; and up to 10 sick days per calendar year. Equal Opportunity Statement We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class. #J-18808-Ljbffr Exelixis Inc