Senior Director Clinical Quality (GCP)
A small pharmaceuticals company headquartered in Central London seeks a highly experienced GCP Quality professional to join their team as a Senior Director. You will provide strategic advice globally and promote compliance by entrusting and building long-standing relationships. If you are looking for an innovative organisation where you can play a lead role as part of senior team then please click apply to make an application.
- Lead the Clinical Quality (GCP and GPvP Compliance) function within Europe strategically
- Promote a compliance mind-set globally through building strong, trusted relationships
- Lead and influence continued GCP/GPvP inspection readiness for EMA GCP Audits and Inspections
- Lead and manage global GCP and GPvP compliance projects
- Partner with key internal and external stakeholders to ensure Europe sponsored clinical trials are designed and executed in accordance with GCP
- Design, maintain and improve the European GCP/GPvP Quality Management System
- Work in partnership with other functions within Europe (and globally) to find pragmatic solutions which both help the business operationally and maintain compliance
- Lead, inspire and motivate the GCP/GPvP Compliance function, ensuring the correct capabilities are in place and utilised effectively
- Support and deputise for the Head of Quality, Europe for all GCP & GPvP Compliance Leadership matters
- Raise the profile of the GCP & GPvP function; promote a culture of a “100% Compliance” mind-set within the organisation
- Work effectively to support and influence the global GCP & GPvP Quality organisation and associated projects
- Strategically build, enhance and innovate GPvP/GCP aspects of compliance
- Drive global QA alignment for GPvP/GCP and support the organisation’s move towards global solutions
- Partner and support the compliance journey for GPvP/GCP activities across Europe achieving a “Right first time” approach in relevant issues/initiatives
- Manage, host and support GPvP/GCP regulatory inspections
- Responsible for designing, setting up, maintaining and execution of robust compliance projects for GPvP/GCP ensuring compliance with regulatory standards, company policies, SOP’s and procedures
- A proactive subject matter expert in GPvP/GCP, providing high standard of quality guidance, advice and pragmatic, helpful support on GPvP/GCP compliance across Europe
- Provide appropriate training on developments in GPvP/GCP compliance and GPvP/GCP quality matters impacting Europe
- Lead the design and maintenance of a compliant and efficient quality assurance system and culture
- Responsible for co-coordinating with Global Compliance to ensure implementation and execution of global GPvP/GCP audit programmes
- Work in partnership with senior leaders to resolve critical GPvP/GCP issues and problems
- Act as a conduit for serious breach / scientific misconduct investigations.
- Supporting the EU head of QA & C as required
Permanent and full-time
Office based in Central with flexibility to work from home
SALARY / PACKAGE
Attractive basic salary plus excellent benefits
ABOUT PLANET PHARMA
Planet Pharma is an American parented, global Employment Business / Agency providing Global Staffing services. We are head-quartered from Chicago with 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.
If you would like to discuss this vacancy further or to discuss your career options in confidence please telephone Sam Chapple on ******************* or e-mail ****************************
If this role isn’t 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! 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.
This job was originally posted as www.emedcareers.com/job/960538095