Senior Manager, Audit and Supplier Management
New
4
4DMTBiotechnology
Remote, United StatesContractManager
Salary75 - 86 USD per hour
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Job Details
- Experience
- 8+ years working within a regulated environment; 3+ years in a role providing GxP QA oversight
- Required Skills
- GCP
Requirements
- B.S./B.A. in a science or related life science field; advanced degree preferred.
- 8+ years of experience working within a regulated environment (Regulatory, Quality, Pharmacovigilance, or Clinical Development/Operations).
- Minimum 3+ years of experience with GxP QA oversight.
- Proven experience with GxP Quality Management Systems and QA audit support.
- In-depth understanding of GMP and GCP requirements for investigational products.
- Practical experience with clinical quality assurance throughout the clinical development life cycle.
- Proficiency in quality investigation and root cause analysis techniques.
- Excellent oral and written communication and interpersonal skills.
- Ability to work in a fast-paced environment with minimal direction.
- Ability to travel up to 5%.
Responsibilities
- Coordinate and manage clinical site, internal, and vendor audits including scheduling, planning, and documentation.
- Perform detailed review of audit deliverables to ensure accuracy and GxP compliance.
- Establish and update risk-based Annual Audit Schedules for clinical sites, systems, and vendors.
- Collaborate with stakeholders to facilitate Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs).
- Maintain an accurate Approved GxP Supplier List and manage supplier risk assessments and qualifications.
- Develop and report audit and supplier quality metrics for management reviews.
- Drive continuous improvement of the Quality Management System.
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