Exelixis, Inc.
GMP QA Manager (Finance)
SUMMARY:
Responsible for the oversight of GMP Contract Manufacturing Organizations specifically in the area of Clinical Packaging and Labeling vendors. Assists in conducting review of all associated documentation.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide support as needed for the review of manufacturing, testing and labeling/packaging batch records, and CMC documents submitted to regulatory agencies.
• Coordinate investigations with vendors and interdepartmental teams to resolve potential product quality issues.
• Oversee the generation, review and/or disposition of internal and external documents used in GMP activities.
• Support the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GMPs.
• Understand regulatory agency policies and guidance as it pertains to QA issues.
• Assist in monitoring current and proposed quality and scientific issues and advise supervisor on events for Exelixis.
• Assists with the development of work instructions and standard operating procedures.
SUPERVISORY RESPONSIBILITIES:
• None.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and eight years of related experience; or,
• MS/MA degree in related discipline and six years of related experience; or,
• PhD in related discipline and three years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
Experience:
• Typically requires a minimum 5 years of related QA experience, and/or combination of experience and education/training.
• At least 8+ years of progressive related experience.
• Experience in the biotech or pharmaceutical industry is preferred.
Knowledge/Skills/Abilities:
• Working knowledge of the commercial and clinical manufacturing and quality process, and the Federal laws and regulations affecting the pharmaceutical industry.
• Has extensive experience in relevant industry/profession including primary product quality decision making.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Develops technical solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Interprets, executes and recommends modifications to company wide policies and/or divisional programs.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Excellent verbal and written communication skills.
• Must be proficient in Word, Excel and PowerPoint.
JOB COMPLEXITY:
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Able to multi-task (review multiple batch records and track other documents that require follow-up for multiple vendors).
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the manufacturing processes and corporate goals.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Work with various CMOs and team members to ensure Exelixis project/program goals are met.
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.
Exelixis is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, age, or national origin.
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.