ProClinical is advertising a vacancy for an PVQA Manager position with a leading biotechnology company that specialises in RNAi therapeutics. The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases. The PVQA Manager will join this company in their office in Maidenhead, though the position has plenty of room for flexible or home-based working. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
The Quality Assurance Manager, Pharmacovigilance (PVQA) will be responsible for supporting the Good Vigilance Practices (GVP) audit program activities, as well as contributing to the company's GVP Inspection activities, as it pertains to inspections at the company's facilities, vendors and investigator sites used for their studies.
- Participating in the development of risk-based GVP auditing schedules and inspection readiness activities.
- Supporting the GVP vendor audit, internal audit, and inspection activities.
- Collaborating with internal and external customers to support GVP audit and inspection readiness activities and address audit observations.
- Participating in or managing GVP internal and external audits, as well as GVP mock inspection or related activities.
- Supporting GVP QA during regulatory inspections.
- Overseeing the provision of GVP audit and inspection metrics for management review.
- Identifying and escalating critical GVP findings to Sr. Management.
- Supporting continuous improvement activities for the GVP Audit Program.
- Investigating and managing Quality Events/Investigations to determine root cause.
- Implementing new CAPAs, managing, and tracking to resolution.
- Participating in SOP writing/review.
Skills and Requirements:
- Minimum BS degree in life sciences, engineering or related field
- Minimum 8 years of experience of working in a quality role in GVP Quality Assurance (biopharmaceuticals experience preferred)
- Experience performing internal and external GVP audits (auditor qualification preferred).
- Experience in supporting GVP regulatory inspections
- Experience in supporting internal and external GVP audit program activities.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Highly Competitive Salary
ProClinical, in support of our client, are seeking an individual to fill the role of Manager of Pharmacovigilance (PV) Operations, based in Boston, MA.