Senior GCP/PV/GLP QA Manager

SUMMARY/JOB PURPOSE:

The Senior GCP/PV/GLP QA Manager is accountable for assisting development, implementation and maintenance of end-to-end QA systems and activities for GCP/GLP/PV operations, including planning and conducting 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 cGCP and understanding of the international regulatory landscape.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•  As QA Core, support QA Partner:
• Responsible for assisting the development of internal processes and systems related to GCP/PV/GLP 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/PV/GLP audits to contractors, conducting audits, and regulatory inspections;
• Responsible for developing, tracking and managing periodic management reports including key GCP/PV/GLPcompliance 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/PV/GLP consultants, as applicable;
• Implements policies and/or procedures within GCP/PV/GLP 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:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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/The Ideal for Successful Entry into Job:

• Typically requires a minimum six to eight (6-8) years of related CQA, GCP, PV 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:

• Demonstrated knowledge of the drug development processes
• Demonstrated GCP/PV/GLP audit conduct and management experience is required.
• Working knowledge of supporting GCP/PV/GLP preparation and submission activitiesfor 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.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure).
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research, PV and GLP processes and corporate goals.
• Exercises independent judgment in methods, techniques and evaluation of criter