This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the bio-pharmaceutical and related industry sectors, from contract development services through to contract manufacturing services, to some of the largest biopharma and pharma organisations globally. This business has announced expansions into geographies such as the U.S. and most recently Ireland, where a significant investment has been undertaken to build a new cell culture green-field manufacturing site which has recently been completed. This site now holds the accolade as being one of the largest single use biologics manufacturing plants globally. This site has been designed to run continuous bio-processing, a next-generation manufacturing technology, which will be implemented for the first time at this site, which employs in the region of 400 staff. An exciting opportunity has arisen for an Quality Control Leader to join the organisation as it ramp ups into commercial manufacturing whilst leading a lab operation at site.

The Position:

• Key member of the QC Leadership Team. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
• Work closely with all senior leaders to ensure work practices and targets are achieved in line with the business targets and objectives.
• The role will require extensive liaison with counterparts and business leaders in the organisation to include the highest level of professional representation of the local site QC organisation.
• From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
• Develop/build a world-class biologics QC product-testing team, including planning, recruiting/hiring, coaching/mentoring, and training for 15-20 total headcount.
• Provide the highest quality analytical support for biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOP's, and safety regulations.
• Interact with internal and external partners, clients, and inspectors and maintains high quality standards and services.
• Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
• Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.
• Serve as a technical lead supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.
• Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficiency while maintaining full compliance.
• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
• Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
• Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence.
• Ensure QC staff receive appropriate GMP training and maintain compliance and high quality standards.
• Create a safety culture, enforce safety measures and ensure QC staff work in a safe environment.
• Ability to work in a team environment and independently as required.
• Ensure the tasks associated with the start-up and routine operations, applicable to the role, are carried out in a safe manner.

The Person:

• University degree in related science/quality discipline required. Ph.D. with 5-8 years of experience, or Masters with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field desired.
• More than 15 years working within a Quality Control environment, with a well-rounded exposure to all areas in this field.
• Ability to handle regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.
• Ideally, experienced in establishing a QC function and building a team in a 'greenfield' context of similar size and scale.
• Management/supervision of personnel, with particular attention to schedules and shifting priorities, is required together with demonstrated leadership skills.
• Previous experience with regulatory inspections and internal/customer audits is strongly preferred.

To learn more about this role apply online or contact Gamy Anbalahan on + 353 1 6321823 for a confidential discussion.