Job Description

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the Southeast region and attracts high performing talent through close collaborations with universities and colleges in the region.

We are seeking a QC Team Lead to join the team. Reporting to the QC Manager, the QC Team Lead will ensure that objectives are effectively achieved and consistent with company requirements to ensure compliance, safety & reliable customer supply for our Carlow site.

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Lead and mentor the Sample Management Team.
• Lead projects, promote teamwork, resolve issues, coach and guide others.
• Drive CGMP/GDP compliance in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (Complete, Consistent, Enduring and Available) (ALCOA+) are adhered to for records and data in day-to-day business activities.
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of our products.
• Provide expertise & quality support for the introduction of new products onto site in relation to product release where required.
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
• Liaise with the Quality/ Business Area Specialists/QC/QP/QA Lead to resolve quality related queries where required.
• Use expanded conceptual knowledge to provide mentoring and guidance to the relevant support functions to ensure manufacturing and release activities, resolution of investigations and assessment of change controls are performed in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Participate in internal and external audits and inspections, ensuring department compliance/readiness, taking the role of auditee for assigned areas of responsibility.
• Build knowledge and exposure to MPS principles to identify and support continuous improvement and knowledge management by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
• Schedule daily and weekly tasks for the Sample Management team to ensure workload is visible and aligns with the team KPIs.
• Support the Sample Management team in daily troubleshooting.
• Take ownership of responsibilities and demonstrate initiative in identifying solutions and drive tasks through to completion.

*This is not an exhaustive list of duties*

In order to excel in this role, you will more than likely have:

• Bachelors Degree or higher in science discipline preferred (5+ years relevant experience in lieu of degree will be considered)
• 3+ years of experience in the pharma industry.
• Strong understanding of GMP, data integrity and ALCOA+ principles
• Proven leadership skills with the ability to lead a team is essential
• Strong troubleshooting experience
• Effective communication and interpersonal skills for seamless collaboration.
• Ability to drive continuous improvement and manage lean projects.