Clinical GCP​/GVP Manager

Job Title:
Clinical Quality Manager (Senior Manager GCP/GVP)

Job Duration: 6 Months Contract – W2

Job Location:
Alameda HQ - 1851 Harbor Bay Parkway, Alameda California 94502 (Onsite)

Note:

The Senior Manager GCP/GVP

• Must Have:
  Must have a good understanding of Good Clinical Practice and has work on clinical study teams as a Quality Representative. In-depth knowledge of ICH GCP E6 R3 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
• Nice To Have: GMP drug development experience, GCP (clinical) QA support of a sponsor, CRO, or sites
• Regular Shift 8AM - 5PM PST

Job Description:

Summary/

Job Purpose:

• The Senior Manager GCP/GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.
• Develops and implements GCP and GVP functional strategy to support cross-functional deliverables to ensure that quality is embedded within all steps of client clinical research and operations. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Operations, study and project teams, Medical Affairs, Regulatory, and Global Patient Safety, and other functions, as applicable. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.
• Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for client business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between client business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables.

Education/Experience/Knowledge &

Skills:

Education: BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6 years of related experience

Experience:

• Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Must have attention to detail and good investigation, problem solving, and organizational skills.
• This position requires knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.