Associate Compliance QA Director (Onsite)

SUMMARY/JOB PURPOSE:

The Associate Compliance QA Director is responsible for QA oversight of the end-to-end vendor management program. This person will develop and maintain the approved vendor list and a apply quality risk management (QRM) and phase-based approach. This individual will oversee GxP vendor audits and monitor on-time report completion and audit findings closure. The Associate Compliance QA Director is responsible for maintaining vendor management and audit-related records.

This person will represent QA as the QA Partner (Primary Point of Contact), be the speaking Voice for Quality and Exelixis business stakeholders, and represent QA in an outwardly and business-facing capacity in strategic and decision forums. The Associate Compliance QA Director will triage communication between Exelixis business functions, internally or externally, and QA to provide and ensure delivery on company core goals and pipeline deliverables. This individual will also be comfortable with managing ambiguity and applying QRM to vendor-related issues.

This is an onsite role (5 days a week) based at the Alameda, CA headquarters.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Create, maintain and continuously improve an end-to-end vendor management lifecycle framework that defines all aspects of a vendor lifecycle program, and provides QA oversight using Quality Risk Management (QRM).

• Provide cross-functional vendor management QA oversight where required.

• Author and update QA documents as necessary.

• Using QRM, identify, mitigate and resolve issues and risks associated with vendor management, escalating issues timely.

• Support internal and external stakeholders in monitoring vendor performance.

• Oversees auditing of GxP external vendors to include planning and preparation, monitoring the successful execution of audits, ensures on time report generation, and monitors timely closure of audit finding responses.

• Define and maintain the tracking and trending of quality metrics related to vendor management oversight.

• Apply applicable Health Authority regulations and guidance related to vendor management oversight. Review new regulations and guidance on a frequent basis to assure compliance, and ensure information is escalated across the organization.

• Provide expertise, providing options and opportunities to build Quality into the system and drive value to the overall business.

• Drive for results and propose feasible solutions that will ensure timely delivery on core company objectives.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/ BA preferably in the life sciences or STEM disciplines and a minimum of 11 years of related experience; or,

• MS/M.Sc. preferably in the life sciences or STEM disciplines and a minimum of 9 years of related experience; or,

• PhD preferably in the life sciences or STEM disciplines and a minimum of 5 years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Minimum of 10 years of experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.

• This position requires a broad range of knowledge and experience with GxP processes related to managing vendors, partners, and suppliers

• Requires broad experience with GxP processes related to vendor management, strong partnerships with internal and external partners to resolve issues for continuous improvement, and ability to build user-friendly systems right-sized for the organization to pragmatically apply applicable Health Authority rules and regulations and international standards and guidelines.

• Demonstrated knowledge of GxP Health Authority Regulations and Quality Systems. Knowledge of biologics and chemical processes is preferred.

• Proven organizational and management skills to build systems and coordinate multi-discipline project groups.

• Demonstrated ability to present to a variety of audiences, including HA inspectors, Partners, and Senior Management.

• Experience with presenting or defending departmental functions in audits or regulatory inspections.

Knowledge/Skills:

• Deep knowledge and understanding of clinical and commercial processes and associated regulations related to GxP.

• Excellent written, verbal, and presentation communication skills, able to translate complex concepts across all levels of the organization.

• Strong collaboration skills and demonstrated ability to lead through change and identify opportunities driving positive business outcomes.

• Excellent organizational agility gets results while strengthening internal and external relationships.

• Makes timely decisions and escalates issues and risks supported by QRM principles.

• Ability to influence decision-makers utilizing sound problem-solving skills to recommend options and implement feasible solutions.

• Highly skilled in the ability to work with ambiguity and complexity; can continuously modify options and solutions across all levels of the organization.

• Ability to deliver on company core objectives and principles and achieve goals with measurable impact and outcomes.

JOB COMPLEXITY:

• This role requires a skill set that includes the ability to lead change by engaging others, assessing unforeseen situations, and continuously learning to achieve a goal.

• This role is critical to the success of the clinical and commercial programs and requires continuous communication to maintain alignment across the organization.

• This role requires the management of multiple competing priorities and the ability to evaluate data to detect weak signals and blind spots and escalate cumulative risks.

WORKING CONDITIONS:

• This is an onsite role (5 days a week) based at the Alameda, CA headquarters.

• Travel as required.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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 $154,000 - $217,000 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.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.