SUMMARY/JOB PURPOSE:

The Associate Operations QA Director - Commercial Release is accountable for for the end-to-end QA oversight for lot release and disposition of commercial or clinical products, including Registered Starting Materials, GMP intermediates, etc. Manages all QA aspects of lot disposition. Identifies, mitigates and resolves issues and risks, and escalates to ensure product quality; in a product quality risk log, so that weak signals are captured, and full awareness is escalated appropriately. This position actively partners with internal and external stakeholders in the end-to-end lot release process.

Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, 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.

Provides leadership and guidance to QA, partners and key stakeholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for timely lot release and disposition of products manufactured at contract manufacturing organizations (CMOs), by performing review and QA approval of the product release package, and issuing the release certificate.
• Provide leadership and quality guidance on quality process improvements and business processes, to QA, cross-functional partners, Exelixis customers, partners and collaborators.
• Coordinate cross-functional activities to enable product realization, batch disposition and timely product supply per supply timelines.
• Partner with technical operations and supply chain to ensure forecast and lot disposition planning, including cross-functional planning, lot restriction/flagging and release tools.
• Communicate clear requirements for documentation related to change controls, deviations, product complaints, release/disposition and returns, as applicable, and drive tasks to completion.
• Work with stakeholders to identify, communicate, escalate and mitigate product and process risks.
• Define and oversee tracking and trending of quality metrics for lot disposition.
• Provide cross-functional lot disposition technical expertise and leadership beyond Quality’s sphere of influence.
• Support product transition from late stage clinical to commercial, new product introduction and network flexibility.
• Participate in audits and inspections as requested, and due diligence activities.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of eleven (11) years of related experience; or,
• MS/MA degree in related discipline and a minimum of nine (9) years of related experience; or,
• PhD in related discipline and a minimum of five (5) years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in the biotech or pharmaceutical industry, commercial and clinical manufacturing, and packaging/labeling is preferred.
• Equivalent combination of education and experience.
• Experience in assisting the development of business strategies, metrics, and continuous improvements.

Knowledge/Skills:

• Demonstrated knowledge of commercial and clinical manufacturing, quality processes, US/EU regulations for pharmaceutical industry. Interprets regulatory standards, provides insight into current processes, recommends modifications to corporate procedures. Working knowledge of ICH guidelines.
• Influencer, strong interpersonal, analytical and business communication skills, driver and negotiator. Builds productive internal/external working relationships.
• Expertise/knowledge and skills contribute to development of company objectives and principles, drives for results and achieves goals in creative and effective ways.
• Uses broad expertise or unique knowledge and skills to drive and deliver on company core objectives, and achieve goals with measurable impact and outcomes.
• Demonstrates a high level of independent quality judgment and acumen
• 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 organizational agility that demonstrates how to get results while strengthening internal and external relationships.
• Drives successful completion of major programs, projects and objectives.
• Detail oriented, precise execution of tasks and processes, multi-tasks.
• Exercises independent judgment within defined procedures/practices to determine appropriate action.
• Evaluates and generates data to support departmental metrics.
• Manages significant, unique and complex issues, including evaluation of intangibles, in-depth company knowledge.
• Implements technical solutions within quality requirements to complex problems
• Excellent verbal and written communication skills.
• Proficient in MS Office, including Excel, Power Point and Microsoft Project
• Knowledge of biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.

WORKING CONDITIONS:

• This is an onsite position.
• Travel as requested

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