Head of Compliance

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Head of Quality/Compliance (GCP) Location: Hertfordshire Salary: Dependent on experience, plus extensive benefits package Duration: Permanent Please note, you must be eligible to work in the UK. An exciting opportunity to join World leading Pharmaceutical organisation who are recruiting a Head of Quality/Compliance (GCP) to have responsibility of managing the quality compliance operations team for all of the organisations UK Clinical Trials (Phase I - IV). Reporting directly to the Head of Clinical Operations UK, you will sit on the Governance and Compliance Committee and have oversight of all quality processes. You will be an SME/Authority in Good Clinical Practice and ideally GPvP, will have strong line management and leadership experience and be comfortable being front of house/host of regulatory body inspections including the MHRA. The successful individual will understand the quality landscape and will be comfortable in a strategic role with a proven strategic focus previously. Responsibilities (to include, but not limited to): * Accountable for providing strategic direction ensuring that Global and regional compliance business plans and country business priorities are met within the affiliate. * Identify, assess and resolve quality issues. * Accountable for providing leadership and direction to the quality compliance group, maximizing the productivity and contribution of the quality compliance group through effective management of performance, communication and relations, as well as through individual development and coaching. * Responsible for the management of UK quality activities, including compliance checks, local CAPA documentation and follow up and local GCP/GPvP metrics in order to effectively manage risk in the affiliate. * Leadership of the department during GCP audits and inspections, accountable for ensuring the department is GCP-Inspection ready and acts as the single point of contact for audits/inspections. * Proactively identifies opportunities for continuous quality improvement and ensures effective knowledge and best practice sharing within and outside the department. * Responsible for ensuring effective partnerships in quality related matters with internal functions, local, regional, and global quality groups and external vendors, ensuring where applicable, effective implementation of company GCP quality standards and processes. Experience required: * Expert knowledge of ICH/GCP, global and local regulatory requirements; as well as clinical research or development including operational aspects of clinical studies. * Experience of Change Management - Effectively manages change; explaining the context, answering questions and responds to issues/concerns. * Strategic agility - Provides clarity and focus on key priorities. * Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality. * Decision making - Pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions. * At least 5-10 years' experience in GCP, with experience of clinical research/development in multiple therapeutic areas or in Clinical Quality Assurance. * The ability to clearly convey objectives, deadlines and expectations. * Line management/leadership experience in a similar position within the pharmaceutical/life sciences sector. Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion. GXP, GCP, GPvP, Audit, Auditor, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties, Quality Director, Director of Quality, Head of Quality, Head of Compliance, Clinical Research, Clinical Trials, Good Clinical Practice

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