Exel
Senior GCP/PV/GLP QA Manager
Alameda, CA · Senior
Sponsorship not specified$15k-$20kDetected 31 days ago
GCPExcelFDA RegulatoryCommunicationCollaborationMicrosoft OfficeRegulatory Affairs
About the role
- Ensures rapid escalation and issue resolution.
- Assists in the management of Exelixis partnerships and collaborations and forges strong relationships.
- SUPERVISORY RESPONSIBILITIES: - No supervisory responsibilities.
Responsibilities
- As QA Core, support QA Partner:
- 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.
- 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.
Requirements
- Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with GCP and understanding of the international regulatory landscape.
- BS/BA degree in related discipline and a minimum of 9 years of related experience
- Travel as required (15-20%)
Nice to have
- At least 6+ years of progressive related experience
- Experience in the biotech or pharmaceutical industry is preferred.
Skills
- 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.
- Develops technical solutions to complex problems.
- 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.
- BS/BA degree in related discipline and a minimum of 9 years of related experience; or,
Compensation
- The base pay range for this position is $163,000 - $231,000 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.