|Contact Name:||Larry O’Leary|
required to lead and coach a Quality Operations team, while managing multiple stakeholders and associated project teams, ensuring compliance of all new products transitioning into commercial manufacture through product development systems/processes.
The successful candidate will lead quality improvement initiatives using a variety of different methodologies, directing team resources to the program/projects from technical, manufacturing and administrative areas.
The ideal candidate will be an experienced Quality Manager or Senior Quality Specialist, with proven work experience in delivering quality strategy through the product development process - regulatory compliance, risk management, QbD and quality systems - ensuring products meets all applicable regulatory requirements.
This is a permanent role with an FDA regulated healthcare manufacturer based in Galway
Responsibilities of Quality Manager:
Line Management and development of staff reporting to them in line with departmental and project goals.
Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
Liaise with cross functional groups & associated personnel in ensuring compliance of product development activities to internal and external requirements.
Managing risks associated new products through their lifecycle and improvement of such.
Ensure Product Development compliance with quality policies.
Continually seeks to drive improvements in product and process quality.
Ensure that R&D documentation meets the company's Product Development Process and Control requirements.
Oversee defined reviews, project plans, risk management, validation protocols and reports, for new development projects as well as process changes to existing products.
Requirements for Quality Manager:
Honours Bachelor's Degree in Science, Engineering or equivalent technical discipline.
8+ years' experience in Quality Operations, Quality Assurance, Quality Lead role involving NPDs and NPIs.
2+ years' people management experience, ideally within a Quality function.
Proven project management experience, either upgrading systems or delivering new systems.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Proven systems experience in FDA regulations in Quality functions of Pharmaceutical, Biopharmaceutical or Medical Devices Industry.
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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Key words; Quality Management, Quality Systems, NPI, Product Development, QMS, New Product Introduction, Product Launch, Commercial Launch, Design Control, Quality by Design, Medical Devices, Pharmaceutical, New Product Introduction, Galway, Clare, Connaught.