Quality Operations Manager
|Contact Name:||Larry O’Leary|
Our client, a blue-chip multinational healthcare manufacturer based in Cork, 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 new innovative products coming through development hence it is preferable candidates will have strong experience in New Product Introductions and associated validations.
This long fixed term contract role represents an attractive opportunity for career progression within site and global teams.
Responsibilities for Quality Operations Manager:
Develop strategies for the quality function and execute agreed functional / global strategies and goals.
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.
Responsible for developing a world class-manufacturing team that is proficient in problem solving issues using Six-Sigma tools.
Effective people manager resulting in a motivated high performance team.
Developing staff on new quality initiatives and rollout of quality initiatives across the department/site.
Champions and supports the introduction of key New Product for the business.
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 and across the Corporation where possible.
Champions continuous improvement with particular focus on product quality through six sigma initiatives.
Facilitates and supports the internal auditing process and Regulatory Inspections at the site.
Develops and executes departmental budgets. Control spending and insure compliance to financial requirements.
Requirements for Quality Operations Manager:
Bachelor's Degree in Science, Engineering or similar technical discipline. Masters or PhD is desirable.
8 years plus Quality Management experience in a relevant area Pharma/Medical Device/Biotech, 3 plus years in a leadership 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.
Proven ability to manage complex quality issues and deliver against quality strategies.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Demonstrated experience delivering results in a matrixed environment.
Please phone 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 / www.meddevicejobs.ie
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Key words; Director of Quality, Quality Management, QA Manager, Quality Assurance Manager, New Product Introduction, Pharmaceutical, Medical Devices, Limerick, Cork, Tipperary, Waterford, Munster.