APTS Manager

Clinical Research

East Anglia

£Competitive

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Reference: GCP_WE

Affiliate Process, Training and Systems Manager - Hertfordshire



Star is looking for an APTS Manager to provide direction, leadership and expertise in all GCP compliance activities to the Affiliate Process, Training and Systems group for a major pharmaceutical company.



Main Accountabilities and Responsibilities



  • Accountable for providing leadership and direction to the Affiliate Process, Training and Systems group

  • Accountable for management of CCO UK quality activities, including compliance checks, local CAPA documentation and follow-up and local GCP/GVP metrics in order to effectively manage risk in the affiliate

  • Leadership of CCO for GCP audits and inspections, accountable for ensuring the CCO affiliate is GCP-inspection ready and acts as the Single Point of Contact for audits/inspections

  • Accountable for providing strategic direction ensuring that global and regional APTS business plans/goals and country business priorities are met within the affiliate

  • Accountable for ensuring the CCO affiliate is effectively implementing ICH GCP, Company global and local procedural documents, regulatory and local law requirements to ensure delivery of quality data and maintain patient safety

  • Identify, assess and resolve quality issues within CCO

  • Lead the implementation of relevant global, regional and local initiatives, as require

  • Leadership in recommending, writing, approving and implementing process improvements

  • Accountable for development and delivery of global, regional, and local training on procedural documents and business processes

  • Ensure ICH GCP-related training interventions are recorded and training records are available



Qualifications



  • University degree or equivalent; preferably in a medical/science-related field

  • At least five to ten years' experience in GCP, with experience of clinical research/development in multiple therapeutic areas or in Clinical Quality Assurance



Skills, Experience and Competencies



  • Expert knowledge of ICH/GCP, Company SOPs and local regulatory requirements, as well as clinical research or development, including operational aspects of clinical studies

  • Strategic agility - provides clarity and focus on a few key priorities

  • Decision-making - pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions

  • Managing change - effectively manages change; explaining the context, answering questions, and patiently listening to concerns

  • Teamwork and collaboration - finds and attracts highly talented and productive people

  • Achieving results - clearly conveys objectives, deadlines and expectations

  • Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality

  • Communication: excellent ability to present clear messages accurately in both written and spoken English from complex information/data to all levels in the organisation



Apply for this opportunity now via this website, or call Will on 01628 581 240!




Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.


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