Exel
Associate GCP/GLP QA Director
Alameda, CA · Director
Sponsorship not specified$178k-$252kDetected 31 days ago
GCPClinical TrialsFDA RegulatoryCommunicationCollaborationPublic SpeakingMicrosoft OfficeRegulatory Affairs
About the role
- The base pay range for this position is $177,500 - $251,500 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.
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Responsibilities
- Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
- Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
Requirements
- This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.
- Minimum of 10 years relevant experience in pharmaceutical and biotech industries.
- Experience in Good Clinical Practices highly desired
- Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
- Strong understanding of Quality Risk Management
- Experience using standard MS Office
- Infrequent travel may be required.
Skills
- Understanding of the drug development process, particularly related to QA oversight of clinical trials
- Experience in assisting in the development of business strategies, metrics, and continuous improvements
- Working knowledge of Health Authority rules and regulations
- Ability to apply Quality Risk Management in a variety of situations across Quality Systems
- Strong interpersonal and social skills
- Detail-oriented in execution of tasks and processes
- Excellent verbal and written communication skills
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Provides insight and analysis of situations or data requires a review of a variety of factors.
- Education/Experience:
- Equivalent combination of education and experience.
- Experience/The Ideal for Successful Entry into Job:
Compensation
- The base pay range for this position is $177,500 - $251,500 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
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
- Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
- Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.