Principal Scientist – Quality Control (Compliance) 

Location: County Limerick, Ireland 

Join a leading organisation in the life sciences sector, where you will play a pivotal role in the start-up phase of an exciting new site in Limerick. This Principal Scientist – Quality Control (Compliance) role offers a unique opportunity to lead the quality and compliance activities within the Quality Control Laboratory (QCL), ensuring excellence in laboratory standards and compliance with global regulations. 

About the Role: 

Our client, a renowned pharmaceutical company, is seeking a dynamic and experienced Principal Scientist to provide technical support and leadership in the compliance systems within their cutting-edge QC laboratory. This position will focus on ensuring compliance with all internal and external requirements, including GMP and regulatory standards, while driving innovation through the implementation of digital systems. 

The successful candidate will be instrumental in the start-up phase of the site (2024–2026) and will act as a collaborative, energetic, and technically astute resource for the QC function. 

Key Responsibilities: 

Regulatory and Compliance Leadership 

• Interpret and apply global regulatory standards (e.g., GMP, cGMP) to develop and maintain digital, paper-free systems, ensuring compliance across the QCL. 

• Monitor GMP and compendial compliance, leading efforts to maintain inspection readiness throughout the laboratory. 

Laboratory Equipment Lifecycle Management 

• Design, implement, and manage the lifecycle process for all analytical equipment, including oversight of third-party service providers. 

• Review GMP documents related to equipment qualification and calibration, including DQ/IQ/OQ/PQ for analytical equipment and utilities. 

GMP Readiness & Inspection 

• Own and lead the GMP readiness plan for the laboratories, ensuring consistent and compliant processes during the start-up phase. 

• Lead the QC inspection readiness programme, ensuring the labs are prepared for internal audits and inspections by health authorities. 

Training & Personnel Development 

• Implement the QCL training and personnel qualification strategy, aligning it with site policies and procedures. 

• Act as the QC subject matter expert (SME) for lab processes such as equipment qualification, investigations, and personnel qualification. 

Quality Systems Management 

• Lead root cause investigations and mentor QC personnel in the execution of quality systems, change controls, and CAPA implementation. 

• Author and review key GMP documents, including SOPs, test methods, qualification documents, and validation master plans. 

Collaboration & Influence 

• Work closely with central functions to deliver standardised processes and procedures across QC. 

• Provide ongoing education, coaching, and mentoring to QC personnel, fostering a culture of compliance and continuous improvement. 

Skills & Qualifications: 

• Degree Qualified: Minimum B.Sc. in Analytical Chemistry, Biochemistry, Microbiology, Molecular Biology, or a related discipline. 

• Experience: At least 5 years of GMP experience, with a strong focus on analytical equipment lifecycle management and laboratory compliance. 

• Technical Expertise: Comprehensive knowledge of data integrity requirements, compendial regulations, and proficiency with digital lab solutions. 

• Communication: Strong written and verbal communication skills, with a proven ability to influence and lead across teams. 

• Problem Solving: A proactive and imaginative approach to problem-solving, with the ability to manage complexity and ambiguity. 

Why Join Us? 

This is a unique opportunity to be part of a dynamic start-up in a world-class pharmaceutical environment, where you’ll have the autonomy to lead critical quality control initiatives. Our client is committed to your professional growth and will provide extensive training opportunities, including travel to the US for familiarisation and training. 

Community and Quality of Life in County Limerick 

Experience the best of both worlds in County Limerick – a thriving community offering a high quality of life with stunning natural landscapes, excellent schools, and vibrant cultural experiences. 

Key Attributes for Success: 

• Leadership: Demonstrated ability to influence peers and cross-functional teams. 

• Learning Agility: High adaptability and flexibility to manage change and drive results in an evolving environment. 

• Positive Influence: Trusted to follow through on actions and deliver results while fostering collaboration. 

• Relationship Builder: Proven ability to establish and maintain key relationships across all levels of the organisation. 

• Decision Making: Strong decision-making skills with a results-driven focus, gathering the necessary information to implement the best solutions. 

How to Apply: 

If you are an experienced QC scientist looking for a challenging role within a forward-thinking organisation, we would love to hear from you. Apply today to take the next step in your career and join a team where innovation and compliance excellence come together. 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 

For further information on this role please contact Lisa Lawlor on 0868395533 / stem@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

  

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”