Manager, Quality Assurance - Carlow, Hybrid

Job Description

As a part of our dedicated team at our state-of-the-art Carlow site, you will have the opportunity to deliver life-changing medication to patients across the globe. We're calling for a dynamic and committed Manager, Quality Assurance, who will be instrumental in maintaining our firm commitment to quality and compliance with cGMP and corporate regulations. This role presents an incredible opportunity for you to contribute directly to our purpose - advancing the prevention and treatment to patients. 

Your Core Responsibilities 

• As a key member of our team, you will uphold and promote compliance with cGMP and corporate regulations by supporting operational and business areas, and monitoring site cGMP activities. 

• It will be your responsibility to maintain the principles of data integrity (ALCOA) in daily business activities and complete relevant CGMP training. 

• You will be the cornerstone in escalating any potential CGMP violations or issues that could impact the safety, efficacy, quality, or purity of our manufacturing division's human health products. 

• Your role includes fostering an inclusive culture in Carlow that values safety and compliance, and providing essential training to team members. 

• You will have the opportunity to support the development of enhanced quality reporting measures 

•  and ensure effective communication processes across all company levels. 

• You will actively participate and contribute to continuous improvement initiatives, such as batch record review, discrepancy reporting, investigations, the QMS, CAPA’s, and change control. 

• Your role will empower you to keep job descriptions updated, manage your team within the allocated budget, and promote personal growth and development. 

• Creating team priorities and fostering a high-performing and inclusive culture will be a critical part of your role. 

Who You Are 

You are ready if you have: 

• We are seeking a proactive and detail-oriented professional with a Bachelor's Degree or higher, preferably in a related Science discipline. 

• You should have a minimum of 5 years of experience in pharmaceutical manufacturing facility operations, ideally with Vial and Syringe experience. 

• You should possess a solid understanding of cGMP and Quality Management Systems. 

• Your experience in people management, including coaching and mentoring, will be critical in this role. 

• We value individuals with demonstrated decision-making abilities. 

Nice to have, but not essential: 

• Lean implementation experience or continuous improvement experience would be advantageous 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.  

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't