Senior Director, CMC Product Quality at Exelixis, Inc. in Alameda, California

Job Description:

Position Description:
The Senior Director, CMC Product Quality Leader (PQL) is responsible for the product quality lifecycle, global activities for clinical and commercial products, creating and managing a strategy aligning with business drivers. The role is the a single point of contact for Quality on Non-Clinical Development/CMC teams. The PQL authors and reviews applicable Quality sections of regulatory submissions ensuring completeness. The role is also responsible for generating and maintaining a product quality risk log to ensure that weak signals are captured, and full awareness of these risks are escalated appropriately.

This position requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods and of the international regulatory landscape. This candidate would influence across several disciplines in order to deliver a clear strategy to maintain and improve product quality. This individual must also possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop and drive end-to-end product quality from non-clinical development through the life of the program, including commercial launch, in alignment with commercial business drivers and process development capabilities.
• Provide and represent QA's perspective and expertise on the non-clinical development teams, the CMC team, other product teams..
• Ensure a continuous supply of product is available to studies and patients.
• Identify key product quality issues and risks.Raise full awareness of the risks, including weak signals and potential blind spots and escalate as appropriate.
• Interpret and apply applicable Health Authority regulations and guidance.
• Provide technical expertise and leadership, providing recommendations beyond Quality's sphere of influence.
• Support product regulatory filings by driving clarity and consistency with specifications and CQAs.
• Support product transition from clinical to commercial, new product introductions and tech transfers across the network.
• Ensure alignment of product changes and collaborate with key colleagues to develop bundling strategies that maintain supply while improving product robustness.
• Define and monitor product quality health metrics, including authoring the executive summary of the Annual Product Quality Review.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• Bachelor's degree in life sciences or engineering and fourteen years of related experience; or,
• Master's degree in life sciences or engineering and twelve years of related experience; or,
• PhD in life sciences or engineering and ten years of related experience, or;
• Equivalent combination of education and experience
• QP certification or equivalent is beneficial.

Experience:
• Minimum of 16 years of experience in biotech, pharmaceutical or related industry or the equivalent combination of experience and education/training.
• Minimum of six years of previous people management, either direct or indirect team leadership.
• International/global experience preferred.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.

Knowledge/Skills/Abilities:
• Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in DS/DP/FG manufacturing processes. Knowledge of biologics and chemical moieties, devices, and combination products desirable.
• Understanding of FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
• Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP.
• Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals with measurable impact and outcomes.
• Proven organizational and management skills to coordinate multi-discipline project groups.
• Ability to speak, present data, and defend approaches in front of audiences.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• 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 that have resulted 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 without complete data to ensure quality product to patients.
• Consistently demonstrates sound quality judgement and balances between business, supply and quality aspects.
• 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.

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 program 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.

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.

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