Senior Manager, GCP QA
ProClinical is advertising a vacancy for an Senior Manager, GCP QA 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 Office Coordinator will join this company in their office in Maidenhead. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
- The Senior Manager, QA will lead GCP Inspection and Inspection readiness activities. The Senior Manager will be responsible for ensuring GCP inspection processes, and procedures comply with global regulations. This role also places emphasis on the quality culture through oversight & monitoring key quality indicators.
- Summary of Key Responsibilities:
- Acting as the subject matter expert for GCP regulatory inspection and inspection readiness processes and procedures. (Act as key contact for GCP inspection-related consultancy and activities.)
- Supporting GCP regulatory inspections for Alnylam, vendors and investigator sites.
- Developing, implementing, and maintaining GCP inspection and inspection readiness processes, tools and templates.
- Promoting compliance within the company using quality metrics and/or key quality indicators.
- Supporting the development, implementation, and maintenance of QA systems and SOPs for GCP systems.
- Coordinating, developing, maintaining and/or providing GCP training and other pertinent topics to personnel.
- Coordinating and overseeing inspection readiness activities including, but not limited to, implementation of GCP inspection readiness plans for active programs.
- Driving collection of information requested from regulatory inspectorates for GCP inspections.
- Identifying, assessing, and implementing improvements based on new or revised global regulations and prepare for upcoming inspections accordingly.
- Communicating inspection outcome as appropriate post-inspection with consideration of the confidential nature of inspections.
- Providing training for GCP inspections as needed for Alnylam, vendors and investigator sites.
- Performing tracking and trending of inspectional findings and communicate as needed.
- Implementing quality improvements based upon feedback from inspectional activities (i.e. Lessons Learned).
- Leading the inspection report response process, including identifying response owners for individual observations, reviewers for the overall response, and ensuring that the responses are submitted accurately and on-time.
- Participating in budget forecasting, planning, and tracking for QA.
- Maintaining relevant knowledge of both local and international inspection activities, inspectorate approaches, and appropriate GxP requirements and developments as they impact the company's SOPs and compliance with GxP and communicating these to the QA team and QA management, as applicable.
- Other assignments as directed by the Quality Assurance management team.
Skills and Requirements:
- Educated to degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. Master's degree in a science, technology or industry related discipline, preferred.
- At least 10 years' experience in Quality that support pharmaceutical development and a minimum of 4 years' experience in a staff leadership role, demonstrating strong leadership skills of staff and peers.
- Extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing.
- Expertise in GCP regulations and guidance for FDA and International agencies including ICH GCP guidelines.
- Experience in directly interacting with Regulatory inspectorates and hosting inspections preferred.
- Ability to identify quality issues/discrepancies, and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
- Experience overseeing financial information for a team/department.
- 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.
£0.00 - £45000.00 per annum
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