Qualified Person, Quality

West Pharmaceutical Services, Inc; Dublin; On-site; EUR 82,000 - 104,000; Full time

Benefits offered by this job

Performance-based bonuses

Total rewards programs

Job summary

West Pharmaceutical Services, Inc. in Dublin seeks a Qualified Person (QP) to make disposition decisions for human medicinal products and IMPs assembled at West, releasing them for MAH transfer. The role requires batch certification and EU compliance knowledge, with reporting to the Director of Quality.

Travel up to 20%; hybrid onsite three days per week; join a global company offering development and regulatory training, and opportunities across North America, Europe, and Asia-Pacific.

Qualifications

• EU Directive 2001/83/EC Article 49 as amended and EU GMP including IMP requirements.
• Hold a 4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent.
• Hold a HPRA-recognized postgraduate qualification to act as Qualified Person, such as the Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC.

Responsibilities

• Make disposition decisions for human medicinal products and IMPs assembled at West and released to MAH.
• Certify batches in line with EU Directives and EU GMP.
• Provide regulatory compliance guidance to the West Quality Team and report to the Director, Quality.
• Ensure QMS compliance and participate in regulatory inspections and responses.
• Communicate with MAH, HPRA and regulators as needed.
• Stay informed on regulatory updates and trends impacting West operations.

Education

EU Directive 2001/83/EC Article 49 amended

4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent

HPRA-recognized postgraduate qualification to act as Qualified Person (Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC)

Job description

Select how often (in days) to receive an alert:

Title: Qualified Person, Quality

Requisition ID: 76075

Date: Oct 19, 2026

Location: Dublin, IRL, IE

Department: Quality

Description: This is a hybrid position requiring the team member to be onsite for 3 days per week. No relocation assistance is provided for this opportunity.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The Qualified Person (QP) will have responsibility for making disposition decisions in relation to human medicinal products and Investigational Medicinal Products (IMP) that are assembled at West, released and shipped to the customer (the Marketing Authorisation Holder (MAH), for further processing. This disposition activity represents QP confirmation of partially manufactured Human Medicinal Products. Human Medicinal Products that are assembled, labelled and secondary packaged at Tech Group Europe Limited (t/a WEST) will be required to be batch certified by the West QP as the EU site of batch release. dIn addition, the QP will guide and support the Quality Team at West on all aspects of pharmaceutical regulatory compliance. Report directly to the Director, Quality.

Essential Duties and Responsibilities

• For medicinal products manufactured within the European Community that each batch has been produced and tested/checked in accordance with the relevant EU Directives and the Marketing Authorisation.
• For medicinal products manufactured outside the European Community ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1 (b) of Article 51.
• Certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
• To ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation and the principles and guidelines of EU Good Manufacturing Practice.
• Comply with the duties and responsibilities defined in EU Directives 2001/83/EC and 2003/94/EC and Eudralex Volume 4 Annex 16: Certification by a Qualified Person and Batch Release and contained in a separate technical agreement.

• Have responsibility for making a release decision in relation to medicinal products assembled at West. This decision will be based on a detailed review of batch files and a detailed knowledge of the quality management system and of manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Have responsibility to batch certify human medicinal products assembled, labelled and packaged at West. This decision will be based on a detailed review of West batch files and batch files from the site of drug product manufacture (where applicable) and a detailed knowledge of the quality management system and of the manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Ensure the QMS in place at West to support West as a site of batch certification meets all GMP and regulatory requirements for batch certification including supply chain mapping, risk assessments ad supplier approval processes.
• Review documentation and release certificates for QP confirmation provided by the QP at the MAH/manufacturer of the medicinal product which is to be assembled into the drug delivery device at West.
• Provide advice on regulatory compliance in relation to the Quality Management System, deviations or other anomalies which could impact on the safety and compliance of medicinal products, validation requirements and on other technical matters, as requested.
• Communicate with a customer, MAH, HPRA and other regulatory authorities, as necessary.
• Assist with preparation for regulatory inspections, participate during inspections, agree responses to regulators and advise and follow up on corrective and preventive actions until close out.
• Remain well-informed on regulatory updates for example by attending the annual QP forum, interpreting regulatory drafts or submission to understand impact on West operations.
• Remain informed about performance of the QMS and emerging quality trends and risks such as complaints, audit findings, deviations, non- conformances etc.
• Ensure attendance at West’s quarterly review and West’s management review as it relates to medicinal product.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties as assigned

Education

• Meet the requirements of EU Directive 2001/83/EC Article 49 as amended and EU GMP including IMP requirements
• Hold a 4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent
• Hold a HPRA - recognized postgraduate qualification from an approved university course to act as Qualified Person, such as the Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC, where the primary degree is not Pharmacy

Travel Requirements

20%: Up to 52 business days per year

What We Offer

Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities. Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives. Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment. Recognition & Rewards:Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

Pay Transparency:

The annual base salary range for this position is€81,900.00 - €104,200.00. Total target compensation is determined using objective and gender-neutral criteria, including relevant experience, qualifications, skills, market benchmarks, geographic location, and the scope and responsibilities of the role.

This position may be eligible for variable compensation and other incentive programs in accordance with the terms of the applicable plans within the country of employment. In addition, team members are eligible to participate in the company’s benefits and total rewards programs applicable to their location and employment status.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in orderto apply to West, please send an email to [e-mail] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.