Associate Quality Director - Qualified Person

Dormont Manufacturing Co; Inverin; On-site; EUR 85,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Bonus scheme

Excellent career progression opportunities

Work-life balance initiatives

Job summary

Dormont Manufacturing Co in Inverin is seeking an Associate Quality Director to oversee the Quality Management System. Responsibilities include leading the Quality Assurance department, ensuring compliance with regulatory requirements, and managing audits.

The ideal candidate will have extensive experience in sterile pharmaceutical manufacturing, leadership skills, and proven expertise in quality systems. Benefits include competitive salaries, career progression opportunities, and health insurance.

Qualifications

• Strong experience in sterile pharmaceutical and/or medical device manufacturing.
• Deep expertise across quality systems including deviations, CAPA, audits.
• Excellent communication and stakeholder engagement skills.

Responsibilities

• Act as Lead QP to ensure compliant batch release.
• Manage the Quality Assurance department and mentor staff.
• Lead regulatory inspections and audits.

Skills

Sterile pharmaceutical manufacturing

Quality systems knowledge

Regulatory compliance

People leadership

Analytical mindset

Education

Bachelor's degree in a related field

Job description

The Role & What You Will Be Doing

The Associate Quality Director / QP has responsibility for administration of the Quality Management System at Mylan Teoranta (A Viatris Company), with responsibility to ensure products are manufactured according to all applicable regulatory and corporate guidelines. The Associate Quality Director II/QP is responsible for the day to day management of the QA department, identified as the Management representative per the requirements of ISO 13485: 2016; reports directly to the Associate Quality Director II/QP and where relevant is the nominated designate.

Every day, we rise to the challenge to make a difference and here’s how the X role will make an impact:

QP & Batch Release

• Act as Lead QP, ensuring compliant release of all batches.
• Oversee batch release processes and review batch documentation for accuracy and compliance.
• Collaborate with production to resolve release issues and maintain timelines.

Quality Leadership

• Lead and manage the Quality Assurance department, including mentoring QA Team Leads.
• Own and approve the Quality Management System (QMS).
• Drive a strong quality culture and continuous improvement mindset across the site.

Compliance & Audits

• Ensure inspection readiness and lead regulatory inspections (e.g. FDA, HPRA).
• Manage audits and responses with regulatory bodies, customers, and corporate teams.
• Stay current with evolving regulatory requirements and implement necessary updates.

Quality Systems Oversight

• Own key quality processes including:
• Deviations / Non-Conformance (NC)
• CAPA management
• Change control & impact assessments
• Support new product introduction (NPI) and product launches from a quality perspective.

Stakeholder & Operational Management

• Provide technical quality guidance across the site.
• Influence decision-making to ensure compliant, risk-based outcomes.
• Manage resources, workload, and departmental budget.
• Engage with senior stakeholders at a global level.

People Leadership

• Develop, coach, and retain QA talent.
• Drive performance management, capability development, and succession planning.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Strong experience in sterile pharmaceutical and/or medical device manufacturing.
• Deep expertise across quality systems (deviations, CAPA, audits, change control, supplier quality).
• In-depth knowledge of global regulatory requirements, including:
• EU GMP (Annex 1 & Annex 16)
• FDA / 21 CFR (210, 211, 820)
• ICH guidelines and Part 11 compliance
• Proven experience working with health authorities and notified bodies.
• Strong people leadership and team management experience.
• Excellent communication and stakeholder engagement skills.
• Ability to work in a fast-paced, complex environment and manage multiple priorities.
• Analytical, solution-oriented mindset with continuous improvement (Lean / Six Sigma) awareness.
• High level of decision-making confidence and influence.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.