Senior GCP/PV/GLP QA Manager

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 work