Exelixis, Inc.
Associate Director, GMP QA (Finance)
The role is responsible for the QA oversight of day-to-day GMP Operations at the Contract Manufacturing Organizations and Contract Labs that generate Exelixis products. The Associate Director leads the management of Exelixis' partnerships and collaborations, conducts audits of vendors and suppliers located globally. The responsibilities also include representing the Quality Assurance Department to resolve issues that may have significant impact. The position includes determining methods and procedures on new assignments and may coordinate/supervise the activities of other personnel.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Directs, establishes and maintains QA programs, policies, and procedures to ensure GMP compliance of clinical trial material.
• Acts as the primary QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues.
• Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
• Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
• Contributes to the company's SOP system by authoring procedures related to GMP QA.
• Ensures that the company maintains its right to operate at its Contract Manufacturing Organizations and Contract Laboratories.
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Assists in monitoring current and proposed quality, scientific and pertinent legal issues and advises management on events of significance for Exelixis' business interests.
• Provides support as needed for the review of manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Ability to travel up to 25% is expected for this position.
SUPERVISORY RESPONSIBILITIES:
• Directly supervises employee(s).
• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and minimum ten (10) years of related QA experience; or,
• MS/MA degree in related discipline and minimum eight (8) years of related QA experience; or,
• PhD in related discipline and minimum six (6) years of related QA experience, or;
• Equivalent combination of education and experience.
Experience:
• Experience in the biotech or pharmaceutical industry is preferred.
Knowledge/Skills/Abilities:
• Working knowledge of the commercial and clinical manufacturing and quality processes, including US and EU regulations affecting the pharmaceutical industry.
• Working knowledge of ICH guidelines.
• Has extensive knowledge of other related disciplines.
• Has a significant amount of experience in a virtual manufacturing environment or relevant industry/profession .
• Small molecule technical knowledge required. Oral solid dosage form strongly desired.
• Large molecule technical knowledge is a plus.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy.
• Leads the implementation of process and system improvements/initiatives with minimal guidance from group leader.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Applies strong analytical and business communication skills.
• Excellent verbal and written communication skills.
JOB COMPLEXITY:
• Works on problems of diverse scope where analysis or data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques and obtains compliant solutions.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or leadership from other functional groups.
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.