Quality Operations Manager

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Quality Operations Manager Location: Home Counties Salary: Negotiable/dependent on experience Duration: Permanent An exciting opportunity to join a Global Biologics company who are recruiting a Quality Assurance Operations Manager. You will be responsible for managing, leading and developing two QA Operations teams (20+ direct reports) to ensure team objectives and responsibilities are met. This includes auditing, documentation generation, QC analytical services and product development. Responsibilities (to include, but not limited to): * Support QA Leadership with department strategy development, objectives, goal setting and project prioritization activities. * Lead manage and develop the QA Operations team. * Manage and escalate major and critical compliance issues through the site PQS process. * Actively develop, mentor, train and instill a site GMP culture. * Plan workload for department and support site objectives. * Support batch release process in order to aid on time release of batches. Experience required: * Life Science degree (ideally in Biology, Chemistry or Pharmacy) at Bachelor's level preferably supported by PhD, MSc or MBA. * Strong leadership and line management experience. * Excellent knowledge of GMP regulations and guidelines. Experience desired: * Auditing experience - EU cGMDP/ICH Q7A/ISO9001/PS9001/ISO13485. * Experience in the design and management of a quality system. * Strong batch review/release experience. * Experienced in hosting regulatory authority inspections. * Thorough knowledge and extensive experience of EU cGMDP, Regulatory Affairs, QMS, handling Change Controls, CAPAs, Deviations, Complaints, Complaint Investigations and (both manual and software-based) documentation systems. 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 within a week, you have not been successful on this occasion. Quality Manager, Operations Manager, GXP, GMP, GDP, Audit, Auditor, R&D, Biologics, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties, Line Management

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