Quality & Regulatory Compliance Manager

Recruiter
Recruitment Holdings Ltd
Location
Bristol (City Centre)
Salary
£45k - £65k pa + depending on expience
Posted
07 Oct 2017
Closes
08 Nov 2017
Sector
Accountancy
Contract Type
Permanent
Hours
Full Time
Quality & Regulatory Compliance Manager Role Description This is a role for an experienced Quality & Regulatory Compliance Manager with in-depth experience of the Drug Substance and Medical Device sectors. Previous experience working within an early stage company would also be an advantage. The role will be hands on working with the Operations team, to develop a fit for purpose Quality Management System (QMS) and to assist with the selection, transfer and validation of our drug substance manufacturing processes and analytical methods to 3rd party cGMP Contract Manufacturing Organizations (CMO) in the EU and US. The job holder, in conjunction with our external Regulatory Consultants will assume a significant role in assisting the senior management team with the company's overall Regulatory strategy. The job holder will be expected to: - Optimise and maintain the company QMS system, including Change Management Procedures, Risk Assessment Processes, management of Technical Agreements, etc. - Support the development and maintenance of Module 3 documentation in support of drug substances / device ingredients. - Establish, manage and maintain site regulatory authorisations, where needed (for example, MIA and / or ISO 13485). - Represent the company during Quality and Regulatory / Competent Authority audits either on site or at 3rd party CMO's (including EU Notified Body unannounced audits). - Work closely with the Quality and Regulatory teams of our commercial partners. The job holder will be expected to provide the senior management team with regular progress reports. Candidate profile The candidate will be a self-starter who enjoys leading from the front and relishes the prospect of making a real and immediately visible impact on the success of this emerging bio-pharma company. The candidate must be able to demonstrate a successful track record in Quality Assurance and Regulatory Compliance, preferably with a drug substance supplier. The candidate must demonstrate a track record of having set up and/or managed QMS and Change Management Systems within a drug substance or device ingredient environment. The candidate must be fully conversant with ICH Module 3 (especially ASMFs / DMFs) and / or IMDRF technical file requirements, particularly related to drug substances. The Candidate must have experience with interacting with 3rd party suppliers / contractors / manufacturers and be conversant with cGMP / ISO 13485 obligations relating to the control of drug substances / medical device ingredients. Experience with supporting regulatory agency audits / inspections would be desirable. An appreciation of working within a small company environment would also be advantageous. The ideal candidate will be highly numerate and articulate, able to communicate confidently in both verbal and written form in a concise, factually correct and compelling manner. The candidate must be resilient, self-reliant, able to progress work independently and on their own initiative whilst also thriving in a team environment and as a team player. Job Title: Quality & Regulatory Compliance Manager Reference No: 236305 Location: Bristol Job Type: Permanent Salary: Negotiable Please apply to Laura Bruce, Consultant; ***************; ************ RHL is a specialist Recruitment Consultancy within Life Science talent acquisition. Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency.
This job was originally posted as www.jobsite.co.uk/job/959281649