Quality Operations Manager
|Contact Name:||Larry O’Leary|
Our client, a blue-chip multinational healthcare manufacturer based in Galway, now seeks a suitably experienced Quality Operations Manager to provide effective leadership across the site, contributing to strategic programmes and developing a high performing quality team in an FDA regulated environment.
The scope of this role is wide and varied, with the successful candidate having compliance oversight of a large Operations area generating significant revenue. The company has a number of incredibly new innovative products coming through development hence it is preferable candidates will have strong experience in New Product Introductions and associated validations.
This permanent role represents an attractive opportunity for career progression within site and global teams. The ideal candidate will be an experienced Quality Manager with ambition and ability to progress to develop and progress within the organisation, either with local site or within global teams.
Responsibilities for Quality Operations Manager:
Authority to make decisions related to product quality, including the disposition of non-conforming product.
Participates in Customer Complaints investigation for areas under their control.
Reviews and provides direction on test and validation protocols to establish technical specifications and performance standards for new products and processes.
Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality Management System on site and across the Corporation where possible.
Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
Champions continuous improvement with particular focus on product quality through six sigma initiatives.
Effective people manager resulting in a motivated high performance team.
Facilitates and supports the internal auditing process and Regulatory Inspections at the site.
Requirements for Quality Operations Manager:
Bachelors Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable.
Qualification / experience in Project Management.
10 years plus Quality Management experience in a relevant area Pharma/Medical Device/Biotech, 3 years of which in a Quality Manager / Acting Quality Manager role.
Working knowledge of FDA regulations and all applicable European and ROW markets.
Proven ability to influence across function and at senior levels - building strong networks internally & externally.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Demonstrated experience delivering results in a matrixed environment.
Proven ability to manage complex quality issues and deliver against quality strategies.
Please phone Larry on +353 1-2302400 / email@example.com
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
Key words; Director of Quality, Quality Management, QA Manager, Quality Assurance Manager, New Product Introduction, Quality Systems, Compliance, NPD, NPI, Start-up, Product Launch, Pharmaceutical, Medical Devices, Mayo, Galway, Clare, Roscommon, Sligo, Connaught.
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