GCP/GVP QA DirectorDormont Manufacturing Company • Alameda, California, United States
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GCP/GVP QA Director
Dormont Manufacturing Company
- Alameda, California, United States
- Alameda, California, United States
Über
ESSENTIAL DUTIES/RESPONSIBILITIES
As QA Partner, assist in the development of internal processes and systems related to GCP/GVP activities.
Provide direct support to development and clinical study teams; participate 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.
Develop, track, and manage periodic management reports including key GCP/GVP compliance and QA metrics.
Independently determine approach to complex compliance issues, rapidly escalating report findings, providing recommendations for resolution, and verifying that appropriate CAPA were implemented and documented.
Support, train internal staff and oversee GCP/GVP consultants as applicable.
Implement policies and/or procedures within GCP/GVP QA.
Partner with Regulatory Affairs, Clinical Operations, Translational Medicine, etc., regarding compliance issues, providing compliance guidance to all audited parties.
Maintain knowledge of current regulation requirements; inform 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 13 years of related experience; or
MS/MA degree in related discipline and a minimum of 11 years of related experience; or
PhD in related discipline and a minimum of 8 years of related experience; or
Equivalent combination of education and experience.
Experience
Minimum of 13 years of relevant experience in pharmaceutical/biotech.
Minimum of 8 years GCP/GVP/Drug Safety Quality Assurance experience.
Experience in the development of business strategies, metrics, and continuous improvements.
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.Deep knowledge and understanding of drug development process, Global Regulatory Requirements and regulations related to GxP/ GVP.
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 fosters 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.
Position is onsite.
Travel as required (15‑20%).
Compensation Base pay range: $185,000 - $263,000 annually. The base pay may be adjusted based on geographic region, job‑related knowledge, skills, experience, and internal equity. In addition, Exelixis offers a comprehensive benefits package, including a 401(k) plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, stock purchase opportunity, 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 per calendar year.
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.
EQUAL OPPORTUNITY EMPLOYER 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.
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Sprachkenntnisse
- English
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