Qualified Person

Qualified Person

Dungarvan

About the Role

We are seeking an experienced Qualified Person (QP) to join our Operational Quality team in Dungarvan. In this critical role, you will be responsible for the certification and release of medicinal products, ensuring all products are manufactured, tested, and released in compliance with regulatory requirements, Marketing Authorisations, and current GMP standards.

As a key member of the Quality function, you will provide expert quality oversight, support batch release activities, lead quality decision-making, and work collaboratively across manufacturing, quality, and regulatory teams to ensure products reach patients and consumers safely and on time.

Key Responsibilities

• Certify and release medicinal products in accordance with EU GMP requirements and relevant regulatory standards.

• Ensure all batches are manufactured and tested in compliance with Marketing Authorisations and Quality Agreements.

• Provide quality leadership and guidance across manufacturing and quality operations.

• Support investigations, deviations, change controls, quality risk assessments, and CAPA activities.

• Drive effective problem-solving to prevent recurrence of quality issues.

• Act as a key decision-maker on product quality matters, applying sound scientific and risk-based judgment.

• Support internal and external audits and inspections, including interactions with regulatory authorities.

• Partner with cross-functional stakeholders to ensure timely batch release and uninterrupted product supply.

• Promote a strong quality culture with patient and consumer safety at the forefront of all decisions.

• About You

• Essential Qualifications

You must meet the eligibility requirements for QP status in Ireland, including:

• A recognised Pharmacy degree or relevant Level 8 Science, Medical, or Health Sciences qualification.

• Eligibility to act as a Qualified Person in accordance with HPRA requirements and EU Directive 2001/83/EC.

• Evidence of PSI registration and/or relevant QP eligibility certification where applicable.

• Experience & Skills

• Minimum 5 years' experience within a pharmaceutical, healthcare, or regulated manufacturing environment.

• Strong experience in Quality Assurance, Quality Control, and GMP-regulated operations.

• Comprehensive understanding of EU GMP, Quality Management Systems, and batch certification requirements.

• Knowledge of change control, deviations, investigations, quality risk management, and product quality complaints.

• Strong leadership, stakeholder management, communication, and decision-making skills.

• Ability to work independently and make objective quality decisions in a highly regulated environment.

• Salary range: EUR 66,710.00 - EUR 91,725.70

• The salary range for this position is indicative and provided as a guide. The final offer may vary depending on factors including relevant experience, skills, qualifications, and internal equity considerations. Further details regarding the total reward and benefits package will be shared during the recruitment process. Salary ranges may vary by location in line with local market conditions and applicable pay transparency regulations.

• Compensation information is shared for the primary location of this role. Where the position is advertised with additional locations the compensation range will be discussed during the recruiting process.

• Equal Opportunities

• Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

• Adjustment or Accommodations Request

• If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

• Note to candidates

• The Haleon recruitment team will contact you using a Haleon email account. If you are not sure whether the email you received is from Haleon, please get in touch.