Associate Director, GXP Vendor Quality Assurance Management

Job Description

The Associate Director of Vendor Management is responsible for the Quality oversight of the end to end vendor management program. The successful candidate would develop an elegant, integrated process of approved vendor lists, apply quality risk management (QRM) and work with partners, key stakeholders and other Quality Business Process Owners. The successful candidate would be the single point of contact and represent Exelixis Quality at meetings related to vendor management.

This position requires broad experience with GxP processes related to vendors, partners and suppliers. The successful candidate requires the ability to build elegant systems, working with people across the Product Development and Product Supply Chain organizations to pragmatically apply the applicable Health Authority rules and regulations as well as international standards and guidelines. This candidate should be comfortable managing ambiguity and applying quality risk management processes.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Create an end-to-end vendor management lifecycle framework that defines all aspects of a lifecycle program and provide QA oversight using Quality Risk Management (QRM).
• Provide QA oversight with partners across Product Development and Product Supply Chain.
• Author and update quality documents as necessary.
• Using QQRM, identify and address issues and risks associated with vendor management, escalating issues as appropriate.
• Support internal and external stakeholders for 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 as it applies to the vendor management oversight. Review new regulations and guidance on a frequent basis to assure compliance.
• Provide expertise and leadership, providing options and opportunities to build Quality into the system and drive value to the overall business.

SUPERVISORY RESPONSIBILITIES:

None.

EDUCATION/EXPERIENCE/SKILLS: Education:

• BS/ B.Sc preferably in the life sciences or STEM disciplines and ten years of related experience, or;
• MS/M.Sc. preferably in the life sciences or STEM disciplines and eight years of related experience, or;
• PhD preferably in the life sciences or STEM disciplines and five to eight years of related experience.

Experience:

• 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
• Demonstrated knowledge of GxP Health Authority Regulations and Quality Systems. Knowledge of biologics and chemical processes is desirable.
• Proven organizational and management skills to build systems and coordinate multi-discipline project groups.
• As the subject matter expert, demonstrated ability to present the program to a variety of audiences, including HA inspectors, Partners and Senior Management.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.

Knowledge/Skills/Abilities:

• Deep knowledge and understanding of clinical and commercial processes and associated regulations related to GxP.
• Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.
• Strong collaboration skills and demonstrated ability to lead change and identify opportunities resulting in positive business outcomes.
• Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships.
• Consistently demonstrates managerial courage to make timely decisions and escalate issues and risks supported by QRM principles.
• Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Ability to contribute to development of company objectives and principles and to 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, failing fast 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.

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Additional Information

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.