Job Description:

Senior Specialist, Quality Risk Management & Auditing

Location: BioNX Research & Development Division, Dunboyne

Join a growing, high‑impact site where Quality has a real voice.

We are seeking a **Senior Specialist (QRM & Auditing)**to play a key role within our Global Development Quality Assurance team at our BioNX R&D facility in Dunboyne. In this role, you will lead the site’s Quality Risk Management and Auditing programmes, help shape a culture of continuous improvement, and mentor more junior QA colleagues.

This is an excellent opportunity for an experienced quality professional who enjoys both strategic thinking and hands‑on execution, and who wants to influence how a modern biologics site manages risk, inspection readiness, and compliance.

What you will do

Reporting to the Associate Director, QA Systems and Compliance, you will:

• Lead QRM & Audit governance at site level

• Own and drive site governance for all Quality Risk Management and Auditing activities

• Ensure the site is in a state of permanent inspection readiness

• Build and strengthen quality culture

• Lead training for BioNX staff to ensure a high level of GMP and QMS compliance across Operations, Engineering, Validation, Supply Chain and AR&D

• Act as a mentor and key point of contact for more junior QA team members

• Drive robust Quality Risk Management

• Provide guidance on the completion of all QRM documentation

• Oversee assignment and identification of system owners for risk management documentation

• Coordinate SMEs to complete QRM assessments, mitigation activities and follow‑up

• Support audits and regulatory readiness

• Prepare for and participate in internal and external audits

• Manage audit CAPAs where required, and ensure timely, effective closure

• Support permanent inspection readiness programmes

• Enhance and maintain Quality Systems

• Support the maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation

• Ensure compliance with global and regulatory QMS requirements, including: Quality Manual

• Change Control

• Deviation Management

• Supplier Quality Management

• Quality Risk Management

• Audit Management and associated electronic systems

• Monitor and escalate risk effectively

• Develop, maintain and report relevant quality and risk metrics to site and above‑site functions

• Ensure escalation of compliance and quality risks to management in a timely, transparent manner

• Collaborate and share best practices

• Participate in global and local Communities of Practice for QRM and Auditing

• Work collaboratively with cross‑functional partners to drive a safe, compliant and proactive quality culture in BioNX

• Perform additional duties as assigned by your manager/supervisor

What you bring

• At least 5 years of experience in a GMP environment within pharma/biotech, ideally in a QA, QRM or auditing role
• Solid understanding of Quality Risk Management, audit processes, and inspection readiness
• Experience working with quality systems (e.g., deviations, change control, CAPA, supplier quality) and associated electronic tools
• Ability to interpret and apply global and regulatory quality requirements
• Proven ability to influence, train and mentor others
• Strong communication, stakeholder management and collaboration skills

Why join us?

• The opportunity to shape QRM and auditing strategy at a key biologics R&D site
• Exposure to a wide range of functions (Operations, Engineering, Validation, Supply Chain, AR&D)
• A collaborative, learning‑focused environment where quality is central to decision‑making
• The chance to contribute directly to a culture of safety, compliance and continuous improvement

If you’re passionate about Quality, enjoy connecting the dots across complex systems, and want to lead from the front on risk management and auditing, we’d like to hear from you.

Apply now to join the BioNX Quality team in Dunboyne.

Required Skills:

Audit Management, Audit Management Systems, cGMP Regulations, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Quality Assurance, Quality Auditing, Quality Management, Quality Risk Assessment

Preferred Skills:

Current Employees apply HERE:

Current Contingent Workers apply HERE:

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required:

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/11/2026

A job posting is effective until 11: 59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.