QA Manager

1 week ago

Ballina, Mayo County, Ireland Hollister Full time

We Make Life More Rewarding and Dignified 

Location: Ballina 
Department:  

Title: Quality Assurance Manager

Hierarchical Level: Manager

Division/Department: Quality Assurance

Reports to: Senior Manager Quality Assurance, Ostomy/Continence Care

Number of Direct Reports: 4

Travel: 10% time Domestic & International

Summary:

The position will provide QA leadership and vision as part of a cross functional Plant Leadership Team, striving for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfil our Mission and Vision and make life more rewarding and dignified for the people who use our products. They will support both the Ballina manufacturing facility and the global Quality organization to achieve business objectives.

Responsibilities:

The Quality Assurance (QA) Manager will directly oversee the activity of the QA department and staff. As part of this responsibility, they will generate and maintain a plan for the professional development and coaching of all direct reports including annual goal setting. Develop and maintain an overall strategy for their QA function ensuring communication to key stakeholders for alignment. Responsibility for developing, implementing, and maintaining the QMS for the organizations products and processes ensuring audit readiness and compliance is maintained in line with required standards, regulations and company procedures. Quality oversight for raw materials, packaging components, in-process and finished goods product release. Quality Oversight for change control, complaints, internal audit, risk management, notified body/health authority external audits. Quality oversight for validation activities linked to process, equipment and computer systems. Quality oversight for the introduction of changes to existing products and of new innovative products. Support and lead on the sites operational excellence program ensuring the quality function work towards efficient and effective processes. Provide QA technical direction and guidance to achieve company objectives. Responsibility for preparation and management of the QA operating budget in conjunction with the Operations and Finance functions. Collaborate with manufacturing to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes including leading on cost of quality initiatives. Decision making authority with respect to product quality in consultation with key stakeholders. Participate in Plant Leadership Meetings as required. As part of Hollister's Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required. Represent the site as Management Representative/Authorized Representative/Person Responsible for Regulatory Compliance as outlined in Medical Device regulations if required. Other duties as required.

Work Experience Requirements

Number of Overall Years Necessary: 8-12 5+ years' experience in a Medical Device/Pharma Industry in a Quality Leadership role that includes personnel and Quality System leadership.

Education Requirements

Third Level degree in Quality/Science/Engineering or a related discipline is required. Advanced degree is desirable.

Specialized Skills/Technical Knowledge:

Thorough Knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR etc.). Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies. Good working knowledge of continuous improvement and root cause problem solving in a manufacturing setting. Demonstrated ability to project manage and execute tasks in a timely and efficient manner. Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies. Good interpersonal skills with the ability to work as part of a cross functional team. Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner. Have a continuous improvement mindset and demonstrated change management skills.

Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID: 33427

  • Manufacturing Shift Manager

    1 week ago

    Ballina, Mayo County, Ireland TEAM HORIZON Full time

    Team Horizon is seeking a Manufacturing Shift Manager for our client based in Mayo. In this role you will lead and facilitate the safe operations of the 24/7 Biologics manufacturing team in a bio-pharmaceutical processing facility in line with all safety, regulatory and operational requirements. This is a shift based role, you will be required to work...

  • BioPharma Senior Manufacturing Analyst

    1 week ago

    Ballina, Mayo County, Ireland TEAM HORIZON Full time

    Team Horizon is seeking a BioPharma Senior Manufacturing Analyst for our client based in Mayo. In the role, you will have the opportunity to organize and plan all aspects of operations and manufacturing technicians to execute a schedule defined by Supply Chain and/or other customers. You will ensure that all activities in the area comply with EHS and quality...

  • Biopharma Manufacturing Lead

    3 weeks ago

    Ballina, Mayo County, Ireland Collins McNicholas Full time

    An exciting opportunity for a Biopharma Manufacturing Lead to join a Biologics Leader in the West of Ireland . The Biopharma Manufacturing Lead will be responsible for organising and planning all operations , ensuring Manufacturing Technicians follow schedules set by Supply Chain and other stakeholders. Ensure all activities comply with EHS and...

  • Engineering Project Specialist

    2 weeks ago

    Ballina, Mayo County, Ireland TEAM HORIZON Full time

    Engineering Project Specialist Team Horizon is seeking a Engineering Project Specialist for a leading pharmaceutical company in Mayo. The successful candidate will be responsible for safely coordinating and leading projects associated Facility, Utility and Equipment Projects. Key areas of responsibility include but (not limited to) on time and budget...

  • Associate Project Process Engineer

    2 weeks ago

    Ballina, Mayo County, Ireland Hollister Full time

    We Make Life More Rewarding and Dignified  Location: Ballina  Department: Operations  Title:  Associate Engineer - Controls Hierarchical Level: Professional Division/Department:  Continence Care, Ballina Reports to:  Neil Corcoran (Senior Engineering Manager) Number of Direct Reports: None  Travel: 15% (may increase due...

  • Quality Auditor

    1 week ago

    Ballina, Mayo County, Ireland Charles River Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Manufacturing Controls Engineer

    1 week ago

    Ballina, Mayo County, Ireland Hollister Incorporated Full time

    Dedicated to stoma care   Location: Ballina Department:  Title:     Project Process Engineer, ControlsHierarchical Level:          ProfessionalDivision/Department:   Ostomy, BallinaReports to:        Manufacturing Engineering SupervisorNumber of Direct Reports:         NoneTravel:  0 to Very Low Expectation (may increase due...

  • Quality Auditor

    1 week ago

    Ballina, Mayo County, Ireland Charles River Full time

    For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will...

  • Senior Project Process Engineer

    1 week ago

    Ballina, Mayo County, Ireland Hollister Full time

    We Make Life More Rewarding and Dignified  Location: Ballina  Department:   Title: Senior Process Engineer Hierarchical Level: Professional Division/Department: Ostomy, Ballina Number of Direct Reports: None Travel: No Expectation (may increase due to project work) Summary: The Senior Process Engineer will be based in Ballina,...

  • Associate Project Process Engineer

    3 days ago

    Ballina, Ireland Hollister Full time

    We Make Life More Rewarding and Dignified  Location: Ballina  Department: Operations  Title:  Associate Engineer - Controls Hierarchical Level: Professional Division/Department:  Continence Care, Ballina Reports to:  Neil Corcoran (Senior Engineering Manager) Number of Direct Reports: None  Travel: 15% (may increase due...