Collins McNicholas

Role Responsibilities:

  • Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. 
  • Partners with other departments to ensure that compliance systems are implemented in an efficient manner. 
  • Supports the development and management of GMP compliance systems through the following activities: 
  • Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. 
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement. 
  • Keeps abreast of regulatory compliance trends. 
  • Internal Audit Program 
  • Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required 
  • GMP service providers program 
  • Managing the nonconformance system and CAPA process 
  • Quality agreement process 
  • Change control process and system 
  • Supporting site regulatory inspections where appropriate 
  • Supporting the site induction process 
  • Metrics and report generation from the quality systems 


Role Requirements:


  • The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required) 
  • A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry 
  • Knowledgeable of FDA/EMEA regulatory requirements Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities 


  • Experience of managing project groups or leading teams 
  • Skilled in the use of problem-solving tools/techniques 
  • Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage 


Key Competencies Required:

  • Collaboration and teamwork 
  • Strategic thinker 
  • Problem-solving and attention to detail 
  • Results and performance driven 
  • Coaching and mentoring style 
  • Integrity, trustworthiness and objectivity 
  • Customer focus 
  • Clear communication skills
  • Adaptable and flexible 
  • Inclusive, facilitative style 
  • Builds strong productive relationships 
  • Seeks opportunities to grow and develop professionally 
  • Uses best practices to improve business operations  

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)


In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More