Assoc Quality Assurance Gcp Director

• Reviews and approves Corrective and Preventive Actions (CAPAs)
• Maintains the CQA programs, policies, and procedures to ensure GCP compliance.
• Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance to all audited parties
• Participates in the development and approval for the CQA audit schedule including the contracting of GCP audits to contractors and conducting complex audits;
• Participates in identifying and implementing process and system improvements
• Manages and/or participates in audits and regulatory inspections;
• Assists in developing internal processes and systems related to GCP QA activities
• Maintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization
• Implements policies, procedures and controlled documents related to CQA
• Provides support during external audits and regulatory authority inspections
• Provides direct support to clinical study teams and participates in QA planning and implementation to support study operations;
• Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
• Responsible for developing, tracking and managing periodic management reports including key Clinical and QA metrics that track and trend the quality health of the GCP activities.
• Represents CQA in internal presentations on quality issues, initiatives and projects

• None

• Masters 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
• Equivalent combination of education and experience.
• 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
• 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

• Minimum 6 years GCP Quality Assurance experience preferred
• Experience in assisting the development of business strategies, metrics, and continuous improvements
• Minimum 10 years of relevant experience in pharmaceutical/biotech

• Implements technical solutions within quality requirements to complex problems.
• Guides the successful completion of major programs, projects and/or functions
• Working knowledge of supporting preparation and submission activities, specifically in relation to GCP Quality, for global regulatory filings
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills
• Demonstrated audit conduct and management experience in GCP disciplines
• Evaluates and generates data to support Key Performance Indicators.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Excellent verbal and written communication skills
• Proficient in MS Office and Visio (preferred)
• Demonstrated knowledge of the drug development process
• Working knowledge of key Health Authority rules and regulations as well as international standards.
• Detailed oriented and committed to precision in execution of tasks and processes

• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.
• Works on complex issues with the support of the supervisor where analysis of situations or data requires an in-depth knowledge of the manufacturing processes and corporate goals.
• Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure)
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Work with various CROs and team members in a collaborative nature to ensure Exelixis project/program goals are met.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $146,000 - $207,500 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.