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About this Job
Location: San Francisco, CA (Hybrid 2 days onsite)
Length: 6+ Month Contract
Job Description:
The primary responsibility of this role is to provide oversight of GCP activities which include, but are not limited to: ensuring patient safety, data integrity and compliance with SOPs, GCP and applicable regulations. Additional responsibilities include execution of the GCP Audit Plan as well as support of Inspection Management goals and objectives.
Essential Duties and Responsibilities:
- Plan, conduct, manage, and report results for GxP audits, including audits of internal processes, clinical investigational sites, clinical vendors, clinical study reports, and trial master files.
- Train, coach, and oversee Clinical QA personnel, subject matter experts, and/or contract service providers in preparing for, conducting, and reporting GxP audits, as assigned.
- Actively support inspection readiness activities and associated Health Authority inspections, including assigned War Room leadership responsibilities.
- Participate in cross-functional teams to identify GxP inspection risks and lead mitigation activities to support and defend business processes.
- Identify and communicate potential compliance risks to appropriate stakeholders.
- Develop and deliver inspection-readiness training for subject matter experts and War Room support team members.
- Build effective partnerships with key stakeholders to deliver forward-thinking programs and training that support a sustained state of inspection readiness.
- Review GCP-associated controlled documents, which may include SOPs, protocols and amendments, study-specific documents, study plans, and data management plans, in accordance with applicable regulatory requirements, including ICH E6, U.S. FDA, EMA, and local regulations.
- Provide guidance and support to internal departments and clinical study teams during all phases of clinical development in identifying and investigating potential GCP and compliance issues, including issues related to clinical investigator sites, internal processes, and vendors conducting GCP activities.
- Ensure appropriate and timely corrective and preventive actions are implemented at sites or vendors, as needed, to maintain compliance and inspection readiness.
- Ensure proper evaluation and completeness of deviation/CAPA entries; project manage related processes to support timely completion and closure, triage issues, and report metrics and trends to management.
- Perform other tasks as requested by Clinical QA and/or Executive Management to support Quality oversight activities.
Qualifications:
- Bachelor’s degree in a scientific or related technical discipline required.
- Minimum of 7 years of experience in the biotechnology or pharmaceutical industry required.
- Quality Assurance experience preferred.
- Strong working knowledge and interpretation of global GCPs, particularly U.S. FDA, EU, and ICH regulations and guidelines.
- Ability to execute quality goals over a 1- to 2-year period in alignment with company-wide objectives.
- Excellent written and verbal communication skills.
- Flexible and adaptable in response to shifting needs and priorities.
- Motivated, committed, and self-managed.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
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