GCP Quality Assurance Manager
Seeking a highly motivated and experienced individual for a GCP Quality Assurance Manager position. The position will work in close collaboration with the Clinical, Regulatory, Non-clinical, and Pharmacovigilance departments to ensure compliance with Good Clinical Practice(s), and other applicable regulations. In this position, you will be responsible for the assessing compliance of the company as well as that of company vendors/CROs/clinical sites.
- Conduct internal and external audits, including: clinical site, vendor/CRO, Trial Master File and internal process audits, as needed.
- Review documents and data intended for regulatory submission.
- Ensure internal and external (clinical sites/vendors/CROs) adherence to GCP, GLP and applicable regulations.
- Assist in the writing and/or reviewing of SOPs for the GCP compliance program, quality documentation such as quality agreements and review various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
- Track deviations and CAPAs through completion.
- Assist in the development and tracking of quality metrics.
- Assist in evaluating and investigating clinical study non-compliance, quality events, incidents, queries, and complaints.
- Communicate any critical compliance risks noted from these activities to QA management.
- BS/BA in field of science such as chemistry, microbiology, biology and biochemistry or BS in a related science field such as Regulatory Science.
- 7 - 10 years in a GCP environment
- Experience in site monitoring, inspection readiness or leading and conducting clinical site, vendor/CRO, and internal process audits.
- Practical knowledge of GCP guidance and regulations and FDA inspection process.
- Proficient in Microsoft Office suite (Word, Excel, Powerpoint).
- Proven ability to identify and effectively resolve quality issues and gaps; practical approach to problem solving.
- Experience with CRO management oversight or experience at a clinical trial site preferred.
- Ability to work independently and within a group setting and to interact effectively with internal customers, including Clinical, Medical and Pharmacovigilance functions.
- Strong communication skills (oral, written, and interpersonal) including the ability to give training in aspects of GCP compliance.
- Excellent attention to detail, time management, and investigative skills as well as the ability to manage multiple priorities.
- Demonstrated good judgement and decision-making experience
- Demonstrates flexibility in dealing with change and diversity