Job Title

Quality Manager

Requisition

JR000015738 Quality Manager (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Dublin, IRL

Job Description Summary

This role is the Site Quality Head and Management Representative for the medical device Quality Management System (QMS) at Mallinckrodt Pharmaceuticals Ireland (MPIL) located at College Park Dublin. The position focuses on deploying best in class quality leadership to ensure that activities, processes, and product at MPIL will meet current GMP standards and comply with applicable procedures, standards, regulations and the state of the art. As management representative, this role has authority over the effectiveness and the maintenance of the MPIL medical device QMS. The scope of the position includes R&D projects, supplier management and Dublin quality systems (change control, CAPA, deviations, audits) activities. At Mallinckrodt global level, the incumbent is responsible for medical device Sterilization, Microbiology and oversees biocompatibility deliverables. The role has direct reports and manages personnel to ensure the availability of adequate resources to complete relevant quality tasks.

Job Description

Essential Functions

As management representative, ensure the promotion of awareness of applicable regulatory and quality system requirements and champions the application of best practices as well as an excellent quality culture.
Ensure that the quality system is implemented, and its integrity maintained.
Establish, monitor Quality Key Performance Indicators (KPI) and communicate results to the organization and senior management.
Leads regulatory agency and notified body interaction for the site related to compliance.
Directs and leads readiness for third party audits including notified bodies.
Provide technical leadership in product development projects, design reviews, verification, validation, serviceability, and manufacturability involving R&D and Sustaining Engineering.

Lead, from a Quality perspective, the qualification and management of all suppliers, including contract manufacturers and developers associated with the MPIL medical device QMS
Direct and oversee the internal and supplier audit programs to ensure auditors are assigned, audit schedules are adhered to and the overall process is effective.

Direct and oversee the internal and supplier audit programs to ensure auditors are assigned, audit schedules are adhered to and the overall process is effective.

Direct and lead creation and implementation of programs, policies and procedures to evaluate precision, accuracy and capability of processes, products, productions equipment and testing, measurement, and analytical equipment and facilities.
Lead the review of batch records and release of product. Ensure that any associated investigations are completed, and the impacted lots dispositioned in a timely manner.

Lead the review of batch records and release of product. Ensure that any associated investigations are completed, and the impacted lots dispositioned in a timely manner.

Ensures applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to FDA, ISO quality systems and other applicable regulations.
From a quality perspective, lead site efforts to transition to the EU MDR
Supervise and support investigations related to CAPA, deviations, non-conformances, complaints and facilitate timely closure. Interface with the cross-functional team for Health Hazard Evaluations (HHE) and recalls.
Overall responsibility for the company medical device microbiology and sterilization program to ensure continued compliance with company procedures as well as existing and regulatory industry standards.
Support regulatory submissions by providing input to develop the documents and leading the response to feedback on deliverables for which the incumbent has direct ownership
Oversee the company biocompatibility program.
Ensure the availability of quality resources to support site processes.
Direct report management including goal setting, supervision and appraisal.

Leads the evaluation and approval of product and process changes through the Change Control Board.
Supports and plays a key role during global efforts to standardize the company QMS.

Minimum Requirements

Education / Experience / Skills:

Supports and plays a key role during global efforts to standardize the company QMS.

10 years’ experience in a cGMP-regulated environment
Proven general leadership and quality management experience.
Lead auditor certification and experience in auditing

Competencies:

Ability to lead and front regulatory agency and third-party audits.
Minimum 5 years’ experience in a leadership role
Ability to lead a cross-functional team
In depth knowledge of ISO 13485:2016, ISO 14971:2019, EU MDR, MDSAP, 21 CFR 820, ISO 11135: 2014, ISO 10993-1:2018, cGMP etc
Strong self-motivation, the ability to work independently or as part of a team,
Experience with supplier quality management (including auditing, qualification, development) and risk management

Effective communications (written and oral); good organizational skills and attention to detail; proficient in business solutions software (such as MS Office); good interpersonal skills.
Awareness of all relevant SOPs as they are related to the position.
Willingness to travel

Organizational Relationship/Scope:

Ownership and accountability for all Quality aspects related to the role in support of patient need and regulatory compliance

Working Conditions:

Full time employee located at College Park, Mallinckrodt Pharmaceuticals Ireland working in the office environment.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.