Associate Compliance QA Director - Vendors

SUMMARY/JOB PURPOSE:

The Associate Compliance QA Director - Vendors is responsible for QA oversight of the end-to-end vendor management program. Develops and maintains the approved vendor list, applies quality risk management (QRM) and phase-based approach.

Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, and represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally and QA, to provide and ensure delivery on company core goals and pipeline deliverables.

Incumbent is comfortable in managing ambiguity and applying QRM.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Create, maintain and continously improve an end-to-end vendor management lifecycle framework that defines all aspects of a lifecycle program, and provides QA oversight using Quality Risk Management (QRM).
• Provide cross-functioanl 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.
• 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' 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, and 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 skillset 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 management of multiple competing priorities, and the ability to evaluate data to detect weak signals, blind spots and escalate cumulative risks.

WORKING CONDITIONS:

• This is an onsite position.
• Travel as required.

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