Director of Global Quality Operations
Our client a large diagnostic company are recruiting for a senior
leadership role, Director of Quality Operations. This role will
involve directing and coordinating the Quality Assurance activities
and functions for a number of the plants in Asia/Europe. The position
requires the incumbent to work with Plant QA Heads to design and
implement multiple quality assurance and control systems that are
compliant with Regulatory requirements. 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
organizational 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 Manufacturing plants.
? Direct the Plant Quality Assurance Organizations in Asia/Europe.
? 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 organization 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 organization and encourage diversity within the
organization.
? 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 both quality requirements as well as all
applicable external Regulations.
Requirements
? Bachelor&#**Apply on the website**;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.
? **Apply on the website** years plus experience in QA leadership
role
For further information on this Quality Director role in Galway please
contact Helga Reeves on (phone number removed)
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval Location: Not Specified
Director of Global Quality Operations
Our client a large diagnostic company are recruiting for a senior
leadership role, Director of Quality Operations. This role will
involve directing and coordinating the Quality Assurance activities
and functions for a number of the plants in Asia/Europe. The position
requires the incumbent to work with Plant QA Heads to design and
implement multiple quality assurance and control systems that are
compliant with Regulatory requirements. 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
organizational 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 Manufacturing plants.
? Direct the Plant Quality Assurance Organizations in Asia/Europe.
? 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 organization 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 organization and encourage diversity within the
organization.
? 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 both quality requirements as well as all
applicable external Regulations.
Requirements
? Bachelor&#**Apply on the website**;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.
? **Apply on the website** years plus experience in QA leadership
role
For further information on this Quality Director role in Galway please
contact Helga Reeves on (phone number removed)
Check out all our open jobs on our HERO Recruitment website -
https(url removed)
Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval
We need : English (Good)
Type: Permanent
Payment:
Category: Others
