Senior QA GCP Manager
3 weeks ago
Exelixis is seeking a highly skilled GCP Quality Assurance Manager to join our team. The successful candidate will be responsible for assisting in the development, implementation, and maintenance of QA systems and activities supporting GCP and PV operations. This role will also involve planning and conducting audits of vendors and associated documentation activities.
Key Responsibilities:
* Assist in the development of internal processes and systems related to GCP and PV QA activities;
* Provide direct support to clinical study teams and participate in QA planning and implementation to support study operations;
* Participate in the development and approval of the CQA audit schedule, including the contracting of PV and GCP audits to contractors and conducting complex audits;
* Develop, track, and manage periodic management reports, including key Clinical and PV Compliance and QA metrics;
* Participate in and support various development teams;
* Manage and/or participate in complex audits and regulatory inspections;
* Independently determine the approach to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented;
* Support, train staff, and oversee GCP/PV consultants;
* Implement policies and/or procedures within CQA;
Requirements:
* BS/BA degree in a related discipline and a minimum of nine years of related experience, or MS/MA degree in a related discipline and a minimum of seven years of related experience, or PhD in a related discipline and a minimum of two years of related experience, or an equivalent combination of education and experience;
* At least six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training;
* Experience in the biotech or pharmaceutical industry is preferred;
Preferred Skills:
* Demonstrated knowledge of the drug development process;
* Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines;
* Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV Quality, for global regulatory filings;
* Excellent verbal and written communication skills;
* Ability to influence others as part of a collaborative team and negotiate effective solutions;
* Strong interpersonal and social skills;
What We Offer:
* Competitive base salary range of $140,000 - $199,000 annually;
* Comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts;
* Eligibility for a discretionary annual bonus program and/or sales-based incentive plan;
* Opportunity to purchase company stock and receive long-term incentives;
* 15 accrued vacation days in the first year, 17 paid holidays, including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year;
Equal Opportunity Employer:
Exelixis is an Equal Opportunity Employer and does 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.
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