Quality Operations Senior Manager
|Contact Name:||Larry O’Leary|
Our client, an OEM Medtech manufacturer based in Galway, now seeks a Quality Operations Senior Manager who will manage quality operations activities and associated team in a world class manufacturing environment.
The successful candidate will lead a large Quality team and their performance management, with oversight for all quality issues within operations area, including; NPIs, process & product transfers from supplier sites, manufacturing scale up are in line with KPIs, managing internal and external audit process and ensuring compliance with QMS, SOPs and regulatory bodies.
This hire will exercise significant stakeholder management, internally in partner with engineering and production; and externally with supplier sites, auditors and customer approvals/satisfaction. The salary and package on offer for this role is at Associate Director level.
Requirements for Quality Operations Senior Manager role:
Bachelor's Degree in Engineering, Science, Quality or similar technical discipline.
10+ years' Quality experience, of which 5+ years in a similar Quality Management / Quality Assurance Manager / Leading Quality function role in regulated industry.
Line management / supervisory / people management experience is required, with proven history developing people.
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.
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
Follow us on: Facebook, Linked-in, twitter