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California, United States
Onsite
SUMMARY/JOB PURPOSE (Basic purpose of the job):
The Senior GCP/GVP QA Manager is accountable for assisting with the development, implementation and maintenance of end-to-end QA systems and activities for GCP/GLP operations, including planning and supporting vendor audits, and associated documentation activities. As QA Core, supports QA Partner. Ensures rapid escalation and issue resolution.
Assists in the management of Exelixis partnerships and collaborations and forges strong relationships. Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with GCP and understanding of the international regulatory landscape.
ESSENTIAL DUTIES/RESPONSIBILITIES:
As QA Core, support QA Partner:
Responsible for assisting the development of internal processes and systems related to GCP/GVP QA activities.
Provides direct support to development and clinical study teams; participates in QA planning and implementation to support study operations, development and approval of Clinical audit schedule including contracting GCP/GVP audits to contractors, conducting audits, and regulatory inspections.
Responsible for developing, tracking and managing periodic management reports including key GCP/GVP compliance and QA metrics, as applicable.
Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented.
Supports, trains internal staff and oversees GCP/GVP consultants, as applicable.
Implements policies and/or procedures within GCP/GVP QA.
Partners with Regulatory Affairs, Clinical Operations, Translational Medicine, etc. regarding compliance issues, provides compliance guidance to all audited parties.
Maintains knowledge of current regulation requirements; informs Clinical Development stakeholders of potential impact on the organization.
SUPERVISORY RESPONSIBILITIES:
No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
BS/BA degree in related discipline and a minimum of 9 years of related experience; or,
MS/MA degree in related discipline and a minimum of 7 years of related experience; or,
PhD in related discipline and a minimum of 2 years of related experience; or,
Equivalent combination of education and experience.
Experience:
Typically requires a minimum six to eight (6-8) years of related CQA, GCP, GVP experience, and/or combination of experience and education/training.
At least 6+ years of progressive related experience
Experience in the biotech or pharmaceutical industry is preferred.
Knowledge, Skills and Abilities:
Demonstrated knowledge of the drug development processes
Demonstrated GCP/GVP audit conduct and management experience
Working knowledge of supporting GCP/GVP preparation and submission activities for global regulatory filings.
Excellent verbal, written, and presentation communication skills, able to translate complex concepts across all levels of the organization.
Ability to influence others as part of a collaborative team and negotiate feasible solutions; strong interpersonal and social skills.
Uses broad expertise or unique knowledge and skills to contribute to meeting company core 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 companywide policies and/or divisional programs.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Detailed oriented and committed to precision in execution of tasks and processes
Has knowledge of other related disciplines.
Excellent MS Office, Word, Excel and PowerPoint skills.
Work Environment/Physical Demands:
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
This position is onsite
Travel as required (15-20%)
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If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
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.