Our client, a blue-chip multinational healthcare manufacturer based in Galway, now seeks a suitably experienced Quality Assurance Manager to provide effective leadership across the business, 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 managing the transition of new products from development including new lines, scale-up to commercial manufacture and then Quality oversight of a large Operations area generating significant revenue.
This company has a number of incredibly new innovative products coming through development hence it is preferable candidates will have strong experience in Tech Transfers / NPIs.
This permanent role represents an attractive opportunity for career progression within site and global teams.
Responsibilities for Quality Assurance 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 QMS on site.
Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department.
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 Assurance Manager:
Bachelors Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable.
Qualification / experience in Project Management.
10+ years plus Quality Assurance experience in a relevant FDA regulated industry, ideally 2 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.
Proven ability to manage complex quality issues and deliver against quality strategies.
Some travel required (5%).
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, Pharmaceutical, Biopharma, Medical Devices, Mayo, Galway, Clare, Roscommon, Sligo, Connaught.
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