Director of Global Quality Operations
This is a newly created role and will be responsible for directing and coordinating the QA activities for the EU & Asian sites. This position requires the individual to work with Plant QA Heads to design and implement multiple quality assurance and control systems that are compliant with the business' quality standards as well as all applicable Regulatory requirements (eg. FDA/IVDR/WHO).
The role has responsibility to implement and sustain continuous improvement programs such as Quality Systems Integration and support the IVDR program. Working closely with Divisional and Corporate stakeholders, the Director of QA Ops will ensure that the Plants deliver consistently to produce high quality product, fill customer orders, and drive customer satisfaction/service. The Director will set strategies to optimize organisational efficiency, raise quality standards, manage cost and compliance through new technology, evaluate current practices and transfer knowledge/Best Practice across sites. The Director will advise the Vice President of Quality on critical events such as product quality, safety, and regulatory issues.
This position involves direct interface and activity/strategy coordination with leadership teams in Global manufacturing, Materials Management, Engineering, R&D, Commercial Operations, Regulatory Affairs and Legal.
Responsibilities and Duties
Responsible for implementing and maintaining the effectiveness of the quality system across the relevant Manufacturing plants.
- Develop and execute strategies to optimize QA operations, including Quality testing (analytical, raw material supplier quality, finished product quality release testing), Quality systems (policy, procedures, work practices), Compliance and Quality Engineering functions, and make key decisions on product quality and regulatory conformance issues.
- Provide Quality Assurance oversight to all functions within the Supply Chain organisation including warehouses and distribution operation.
- Implement robust controls to ensure product integrity of released product, in-transit product, returned goods.
- Coordinate product quality issue resolution collaborating with all functions.
- Ensure timely communication with VP of QA and Senior Leaders on critical quality issues that may result in potential business interruption.
- Ensure staffing and leadership continuity through effective recruitment, talent management and retention, and focused development planning.
- Create a diverse organisation and encourage diversity within the organisation.
- Monitor complaint trends, identify, communicate and address adverse trends that may impact customers and future business. Ensure timely corrective and preventative actions are taken to prevent recurrence.
- Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
- Directly responsible for interface with outside Regulatory authorities (FDA, Notified Bodies, MoH, WHO) on quality matters and ensure effective communications as a means to successful closure of any quality issues raised by regulatory authorities.
- Develop and implement quality objectives that are aligned to and support the overall business Strategy.
- Ensure that Manufacturing Plants and associated Warehouse sites operate in compliance with business quality requirements as well as all applicable external Regulations.
- Bachelor's Degree - Engineering/Science/Life Sciences - Post graduate degree desirable.
- Job requires extensive knowledge of Medical Devices and/or IVD manufacturing as well as plant operations/product development, distribution and warehousing.
- Experience managing multiple sites in QA capacity is desirable.
- Proven track record of results managing FDA and other key Regulatory audits.
- Proven track record in driving Continuous Improvement programs.
- The Director must have a wide range of business and technical knowledge and the
- ability to work and interact with several cultures across various time zones.
- Demonstrated effective leadership and managerial skills with sound technical judgment.
- Experience managing in an environment with changing priorities and making appropriate risk based decisions in the face of uncertainty.
- Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders.
- Ability to present complex technical information to Senior Management.
- 10 years plus experience in QA leadership role
If you would like to learn more, click on the 'apply now' button or call Kellie O' Donovan / Aoife Duggan on 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.