Associate GCP/GLP QA Director

Summary/Job Purpose

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.

Essential Duties And Responsibilities

• Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.
• Affirms current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities.
• Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
• Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs).
• PARTNERS WITH OTHER GROUPS INCLUDING REGULATORY AFFAIRS, CLINICAL OPERATIONS, TRANSLATIONAL MEDICINE REGARDING COMPLIANCE ISSUES AND PROVIDES COMPLIANCE GUIDANCE.
• Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization.
• REPRESENTS CQA IN INTERNAL PRESENTATIONS ON QUALITY ISSUES, INITIATIVES, AND PROJECTS.
• IDENTIFIES ISSUES AND RISKS AND PROPOSES OPTIONS AND SOLUTIONS, ESCALATING RISKS IN A TIMELY MANNER.
• PARTICIPATES IN IDENTIFYING AND IMPLEMENTING PROCESS AND SYSTEM IMPROVEMENTS.

Supervisory Responsibilities

None

Education/Experience

• Educational Requirements: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or, Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or, PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or, Equivalent combination of education and experience.
• Experience Requirements: Minimum of 10 years relevant experience in pharmaceutical and biotech industries. Experience in Good Clinical Practices highly desired. Demonstrated experience in Quality Systems including critical analysis of impact 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.
• 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.
• Detail-oriented in execution of tasks and processes.
• Implements technical solutions within quality requirements to complex problems.
• 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 requires a review of a variety of factors.

Working Conditions

• Environment: primarily working in laboratories or in office.
• Infrequent travel may be required.

Compensation

The base pay range for this position is $177,500 - $251,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.