Position: Sr. QA Manager
Location:Remote, US (EST hours)
Length:Permanent
Job Description:
Reporting to the VP of Quality Assurance, the Manager will provide GCP/GMP leadership, including quality oversight and management of all GxP activities internally and externally with vendors. This will include, but not be limited to, inspection readiness and management, quality systems management, internal training program, internal audit program, and external document review and approval, including batch disposition. The ideal candidate will have extensive quality assurance experience within the biotech and pharmaceutical sectors, will be a fast learner and self-motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail and can easily pivot throughout a workday.
Essential Duties and Responsibilities:
- Plans, prepares and conducts GLP/GCP/GVP audits of clinical investigators, nonclinical and clinical vendors and systems.
- Assists in the development of internal and external GLP/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities
- Ensures that audit results are formally and consistently recorded, conducted, reported and that appropriate corrective/preventive actions have been requested and documented
- Participates in the risk assessment of all new and current GxP vendors/CRO partners and conduct or coordinate vendor qualification audits/assessments as needed
- Ensures compliance of quality management system with applicable regulations, quality guidelines and standards
- Assists in the development and maintenance of GxP audit management processes and documentation including policies, SOPs and guidelines.
- Collaborates with Clinical Trial Team members to assess ongoing audit needs and provide GxP guidance to functional teams, and execute directed audits, where required.
- Participates in inspection readiness and preparedness activities (i.e., sponsor monitor, sites, etc.) and provide guidance and support for all GxP inspection activities
- Supports internal and external regulatory inspections and Inspection Readiness activities
- Coordinates and manages Audit Consultants as appropriate
Qualifications:
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 8+ years experience in a related industry
- 5+ years experience in a Quality Assurance role, GLP/GCP/GVP, including both external and internal audits
- Experience working with and providing GCP advice to clinical trial teams
- Previous experience in supporting Regulatory Authority Inspections preferred
- Previous experience in development and oversight of Quality Management Systems
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels
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.
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Digital Prospectors
Apr 09, 2026