Associate Director QC Systems and Compliance

An Associate Director – QC Systems and Compliance is required on a PERMANENT basis by CareerWise Recruitment for our Limerick based start-up Biopharmaceutical Client.

The QC Systems and Compliance team provides support to the QC function owning cross lab programs such as electronic systems qualification and ongoing support, equipment qualification and management program, personnel qualification, compendial updates, inspection readiness and ownership of shared lab equipment.


THE ROLE:

• Provides leadership, direction and governance for the Limerick QC Systems and Compliance team to ensure delivery of operational and scientific excellence. 
• Ownership of QC programs supporting all labs such as equipment and electronic systems, personnel qualification and inspection readiness.
• Technical expertise in regulatory requirement related to QC operations.
• In depth understanding of operations in QC testing including esystems and data integrity requirements.
• Recruits and develops team members to deliver scientific excellence. 
• Develops future leaders within the function and facility. 
• Has a business management, site management and team management role (consistent with the Associate Director position across site) 

Specifically, during the startup phase of the Limerick site (2023 to 2025) leadership will be expected to be collaborative, inclusive, energetic and support the broader Limerick team to: 

• Provide technical guidance to team members and build technical capability within the team.
• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence 
• Develop and implement the systems and processes needed to run the site, leveraging existing Client knowledge and practices where necessary, but also incorporating external experiences and learning.  
• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach  
• Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions and strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.  

 REQUIREMENTS:

• BSc (Hons), MSc, or PhD in Chemistry, Biochemistry, Microbiology ore related disciplines.
• Minimum 8 years working in a GMP pharmaceutical/ biologics laboratory, environment
• Minimum of 2 years’ experience in leadership of a cross functional team

 Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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