Clinical Quality Manager (GCP) - Permanent
- Experience Level
CLINICAL QUALITY (GCP) MANAGER
- The Manager, Clinical Quality is responsible for the designing, establishing, maintaining and executing a robust GCP compliance program, including conducting and overseeing GCP audits, to ensure consistent adherence to relevant regulations, guidelines, strategy and procedures.
- This position will establish and maintain strong relationships with internal and external stakeholders to ensure that quality standards are adhered to at all time and collaborate with global GCP QA members to ensure the initiation/completion of global initiatives.
- In addition, this position will serve as the GCP subject matter expert on various clinical development projects by providing high standard of quality guidance, advice and support on GCP regulatory compliance matters, and participate in and support health agency inspections as required.
- Bachelor’s degree in a scientific field required or relevant experience.
- Good understanding of GCP, knowledge of PMDA/EMA/FDA, ICH and applicable regulations
- Proficient in Microsoft Office Applications (Excel, Power Point and Word)
- Ability to travel at least 10% of the time (International travel is required).
- Extensive knowledge and practical hands-on experience in GCP and applicable legislation
- Comprehensive understanding of pharmaceutical regulatory requirements and impact on the various functions within the business
- Familiarity with database and GLP audit practices
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Ability to develop and manage efficient and effective compliance systems
- Excellent planning and organizational skills
- Ability to project manage, set clear strategic goals, align priorities and lead multiple tasks/activities within a virtual/remote team to successful business conclusion
- Strong decision-making skills and ability to use independent judgment to quickly set priorities, solve problems and resolve conflict
- Excellent oral and written communication skills and ability to adjust communication to different target groups
- Good working knowledge and comprehension of written English and/or Japanese
- Exceptional attention to detail
- Inter-cultural awareness, proven ability to work in an international environment and cross functional team
- Good analytical and judgment capabilities to understand/analyze/synthesis and communicate
- Proven ability to influence senior leaders within the organization on matters of importance
- Customer-focused, good interpersonal skills, assertiveness, team spirit and coaching skills.
- A team player
Permanent / full-time
London with flexibility to work from home
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Sam Chapple on +44 (0) 203 868 8607 or e-mail on email@example.com
- If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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