Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Head of Compliance (GCP): Home Counties Our client, a global powerhouse biotech company are looking for a GCP professional who will be responsible for ensuring that all GCP governed clinical activities in the company are delivered to the maximum standards of quality and competence.
Head of Compliance (GCP)
Location: Home Counties
Salary: Negotiable, DOE, plus Bonus, car allowance and benefits package
Our client, a global powerhouse biotech company are looking for a GCP professional who will be responsible for ensuring that all GCP governed clinical activities in the company are delivered to the maximum standards of quality and competence. In addition, a talented individual who can lead quality and compliance excellence within the local organisation by entrenching quality principles throughout the organisation, across all clinical studies conducted.
Responsibilities (to include, but not limited to)
* Responsible for providing leadership and direction to the group, exploiting the efficiency and influence of the team through effective supervision of performance, relations and communications. In addition management of individual development and mentoring.
* Accountable for management of UK quality activities, including local CAPA documentation, compliance checks and follow-up and local GCP/GVP metrics in order to efficiently manage risk.
* Leadership for GCP inspections and audits, responsible for making sure the company are GCP-inspection ready and acts as the Single Point of Contact for inspections/audits.
* Proactively identify opportunities for ongoing quality improvement and ensure effective knowledge and best practice sharing within and outside the company.
* Leadership in writing, endorsing, implementing and approving improvements to suitable GCP procedural processes, documents and/or tools to certify quality standards and effectiveness.
* Responsible for delivering strategic direction ensuring that regional and global business goals/plans and country business priorities are met.
* Leading the implementation of suitable local, regional, global initiatives, as obligatory.
* Accountable for improvement and delivery of local, regional and global training on procedural documents and business processes, as necessary. Additionally, through efficient collaboration and metrics, that employees are fittingly trained on all suitable local/regional/global processes.
* Minimum five to ten years of experience in GCP with familiarity of clinical research/development in numerous therapeutic areas or in Clinical Quality Assurance.
* University degree or equivalent; favourably in a science/medical-related field.
* Superb knowledge of ICH/GCP, SOPs and local regulatory requirements with clinical research or development including operational aspects of clinical studies.
* Credible project management skills to work with numerous different systems and stakeholders. Moreover, proven strategic ability to successfully focus on key priorities.
* Availability to travel domestically and internationally if needed.
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted, you have not been successful on this occasion.
Key Words: GCP, GXP, QA, Quality Assurance, QMS, Clinical Trials, Inspections, Audit, Inspection Readiness, GVP Metrics, Batch Release, Batch Certification, MHRA, Compliance, QMS, SOPs Manufacturing, Quality Management Systems, London, North London, South London, West London, Oxford, Oxfordshire, Berkshire, Slough, Central London, Greater London, Cambridge, Essex, Kent, Surrey, Middlesex, Hertfordshire, Berkshire, Sussex, Hampshire, Buckinghamshire
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