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Senior Quality Compliance Specialist

Mallinckrodt -
Dublin, County Dublin

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Job details

Full-time

Qualifications

Bachelor's degree

Full job description

Job Title

Senior Quality Compliance Specialist

Requisition

JR000015804 Senior Quality Compliance Specialist (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

The Senior Quality Compliance Specialist leads key elements of the Supplier Quality Management program to ensure suppliers, contract manufacturers, and service partners consistently meet regulatory, quality, and contractual requirements. This role oversees supplier qualification and performance monitoring, maintains and improves Supplier Quality processes and SOPs, and drives risk-based decision making through robust metrics, scorecards, and analytics. The specialist prepares and presents supplier-related insights to senior leadership, manages annual supplier performance reviews, and partners closely with cross functional teams to ensure effective Quality Agreement development and maintenance. This position plays a critical role in strengthening supplier governance, enhancing compliance, and supporting continuous improvement across the organization.

Job Description

ESSENTIAL FUNCTIONS:

Lead the implementation and ongoing management of the Supplier Quality Management program for all suppliers, including contract manufacturers, service providers, and consultants. Responsibilities include maintaining the Approved Supplier List (ASL), facilitating Supplier Selection Team meetings, conducting supplier evaluations, and creating, reviewing, and maintaining Quality Agreements.
Develop, maintain, and improve Supplier Quality SOPs to ensure alignment with regulatory expectations and internal standards.
Provide comprehensive oversight of supplier performance through the creation and management of quality scorecards, metrics, dashboards, and analytics to proactively identify risks and drive continuous improvement.
Prepare and deliver Management Review materials that clearly communicate supplier risk, performance trends, key issues, and improvement priorities to senior leadership.
Manage the Annual Supplier Performance process and oversee supplier governance mechanisms, including the Approved Supplier List (ASL), Vendor Selection Team (VST), and strategic supplier oversight initiatives.
Partner with cross‑functional stakeholders—including site and functional quality management teams—to ensure that the Quality Agreement (QAG) process meets all applicable quality, regulatory, and contractual requirements.

MINIMUM REQUIREMENTS:

Education / Experience / Skills:

Bachelor’s Degree
A minimum of 6 to 8 years’ experience in the FDA regulated industry.
Demonstrated knowledge, including practical application, of QSR/GMP (21 CFR Part 210, 211, 820) regulations and ISO (ISO 13485)/EU standards are required

Competencies:

Excellent organizational, managerial and people skills required.
Ability to evaluate data and quality issues.
Organize and present complex data in a simple and concise manner.
Ability to interpret regulatory requirements and implement appropriately

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to: Senior Manager, Quality and DRP

Direct Reports: NA

WORKING CONDITIONS:

Normal office conditions. Hybrid model (3-day in office).

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

#LI-HYBRID

#LI-GN1

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.

Apply Now

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