Senior Quality Manager, Medtech
|Contact Name:||Larry O’Leary|
Our client, a Medtech manufacturer based in Galway, now seeks a Senior Quality Manager who will manage quality operations activities for the business, and associated function and team in a FDA regulated cGMP manufacturing environment.
This is a leadership role for a high value, highly profitable business, with site and corporate visibility and exposure. Attractive salary and package for the right candidate, equivalent to Associate Director level in Pharma / Biopharma industry.
The successful candidate will partner with Operations and Engineering; effectively head-up and managing all quality aspects for the business, embed quality ethos and culture within in the business. Also, this hire will lead/manage inspection activities of the Quality System related to regulatory agencies and/or notified bodies, across numerous global markets.
This hire will lead the Quality Assurance team, leading their performance management and development. Oversight and responsibility for all quality issues within operations, including; NPIs, product and process transfers from supplier sites, new equipment solutions, manufacturing scale up in line with KPIs, internal and external audit management in line with QMS and regulatory compliance etc.
This hire will exercise significant stakeholder management; partnering internally with: operations, engineering, R&D, regulatory, supply chain; and externally with supplier sites, auditors and customer satisfaction / post marketing.
Requirements for Senior Quality Manager:
Bachelor's Degree in Engineering or Quality Assurance or similar technical discipline.
10+ years' experience in a similar Quality Assurance, Quality Assurance or Quality Engineering role in regulated industry.
5+ years line management / supervisory / people development experience is required.
Detailed knowledge of the regulatory environment, i.e., FDA, cGMP, ISO13485, etc.
Proven experienced with CAPA, deviations and leading investigations.
Experience in conducting audits and dealing with regulatory bodies.
Project management experience is desirable.
Budgetary Management experience is required.
Please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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