Compliance Lead

Hobson Prior are recruiting for a Compliance Lead to join a biotech organisation on a permanent basis in London. You will be supporting the business growth for Quality and Compliance across a range of GxP Systems.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Recruit, manage and optimise the performance of a Compliance team.
• Be the site wide SME for compliance as a QA function and how it relates to a GMP environment.
• Cooperatively define the QA strategy for Customer projects with clients & be a QA project team representative, be customer facing.
• Support on approaches to QA with other SMEs.
• Collaborate with colleagues in the QA, Validation, Regulatory, Operations and Development departments.
• Report to the Group Head of QA on monthly performance.
• Determine Quality Policies and objectives for compliance.
• Develop and implement clinical phase appropriate GxP systems.
• Identify opportunities for improvement and implement those continuous improvement initiatives.
• Implement appropriate regulatory guidance throughout the Group Quality Management approach.
• Participate in the quarterly Quality Management Review meetings.
• Apply Quality Risk Management to all compliance tasks.

Key Skills:

• A self-starter, with a desire to meet targets and drive success.
• Innovative, pragmatic, customer-oriented and team-focused in personality.
• Confidence to challenge and simplify existing systems & processes.
• Robust IT, multitasking and communication skills.

Requirements:

• BA/BSc or equivalent educational background.
• A minimum of 5 years' experience working in the clinical QA field, and strong understanding of the appropriateness of a phased approach to GMP.
• Requirement to have worked for a CDMO at all stages of product development.
• Experience in implementing QMS in accordance to GLP, GCLP or GCP.
• Experience in internal and external auditing of vendors.
• Experience in hosting client and regulatory audits and supporting other business functions with applying appropriate CAPAs.
• A holistic approach to QA management, with the ability to support, mentor and teach across other business functions.
• Robust knowledge and proven ability with quality risk management, root cause analysis and FMEA processes.
• Understanding of the regulatory requirements of GMP.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.