Job Description
Our client, a multinational company, currently seeks an experience Quality Manager to ensure product safety of product manufactured on site complies with company SOPs, cGMP guidelines and FDA regulations.
The successful candidate will lead the Quality Management team and managing associated budgets. This hire will be the point of contact with regulatory authorities.
Responsibilities of Quality Manager:
Ensure quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product.
Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities.
Minimize the number of returned products, through effective analysis by implementing corrective actions and timely investigation and response to field events.
Reduce costs by employing Quality/Reliability.
Recruits, coaches and develops organizational talent.
Demonstrates effective change leadership.
Builds strategic partnerships to further departmental and organizational objectives.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, EEO regulations, etc.).
Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
Requirements for Quality Manager:
Honours Bachelor?s Degree in Science, Engineering or similar.
2+ years? experience in a Quality / Quality Assurance Management role in FDA manufacturing industry.
8+ years Quality Assurance / Quality Management experience in manufacturing industry, ideally GMP.
Proven project management experience in continuous improvements / Quality initiatives / Process improvements.
Experience/training in problem solving and process improvement methodologies.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.