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Quality Assurance and Compliance Manager

Posted on Jan 29, 2019 by Anonymous

Not Specified Ireland
Health Care
Immediate Start
€65k - €80k Annual

With major sites across Europe, ESS Recruits client has built a global CRO company uniquely designed to meet the needs of life sciences clients in the Agrochemical, Pharmaceutical, Chemical and Veterinary product sectors. They work with them as a Contract Research Organisation (CRO) partner, helping them to bring their range of products to market in a rapidly evolving and demanding environment.
Their industry leading Irish business (Ballina County Mayo) is expanding quickly bringing new virology and analytical labs and capability to the site. At this time they need to make the key hire of a Quality Assurance and Compliance Manager.

Reporting to the Senior Director, Global GMP QA, this Quality Assurance and Compliance Manager will be responsible for managing the GMP Quality Assurance program to assure compliance with regulatory requirements and minimize any business interruption. With 9 direct reports, this role shall also assist Regulatory Affairs and Compliance management in implementing the company Compliance Program, identify and recommend improvements in the Compliance Program and work with the site management team to assure regulatory compliance and consistency. Key responsibilities will include:

Manage direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled.
Schedule resources to manage compliance systems and assure timely completion of: (1) audits of regulatory records and reports; (2) inspections of facilities and equipment; (3) investigations, (4) audits of methods, practices, and controls; (5) review/approval of SOPs; (6) approval of Change Controls.
Review and endorse Quality Assurance reports of audits and inspections to assure proper and consistent interpretation of regulatory requirements and corporate policies.
Administer programs for measuring compliance and quality through pertinent metrics on key performance indicators and provide periodic reports to management.
Represent the corporation during regulatory and client inspections/audits.
Coordinate the preparation of regulatory and client audit responses and corrective action commitments.
Track corrective actions and apprise management of their status.
Review SOPs.
Assist with Vendor Assessment, client audits and subcontractor audits.
Assist in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
Assist in the development and recommendation of departmental budget and authorize expenditures. Educated to degree calibre, you are an experienced Quality Assurance, Quality Control or Quality Compliance Manager from a GMP/GLP life sciences, pharma, biotechnology or medical devices business. The successful candidate will need to have previous quality auditing experience especially dealing with regulatory bodies such as HPRA and FDA. Proven people management and strategic Quality functional capabilities are a must.

This role will suit an aspiring Quality Assurance or Quality Compliance Supervisor or someone leading a small team, looking for a bigger job and challenge.

This is a superb opportunity to join a highly successful and massively expanding global CRO/life sciences business. Apart from achieving a fantastic work life balance in a beautiful part of Ireland, long term job security and career/training development can be taken as a given. Our client is able to offer a very competitive basic salary 65-80,000 euros and a comprehensive benefits package including management bonus, healthcare, pension and full relocation.

To apply for this role, please contact our recruitment partner Katie Hydes at ESS Recruit in Edinburgh

Reference: 629550433