Associate Director QC Systems and Compliance

Job title:

Associate Director QC Systems and Compliance

Company

Hero Recruitment

Job description

Our client, a leading global pharmaceutical organisation, is searching for an accomplished and motivated QC Systems and Compliance Leader to join their innovative team in Limerick. This is a unique opportunity to take on a leadership role during the critical start-up phase of a major new facility, shaping the future of QC processes and systems within a cutting-edge environment.About the Role:The successful candidate will oversee the QC Systems and Compliance team, providing strategic leadership, governance, and direction to ensure the highest standards of operational and scientific excellence. The role involves ownership of key cross-laboratory programmes, including equipment qualification, electronic systems, personnel qualification, and inspection readiness. With a strong technical focus on regulatory requirements, the Associate Director will play a pivotal role in ensuring that all laboratory operations meet global compliance standards.During the site’s start-up phase (2023–2025), the Associate Director will work collaboratively with the broader Limerick team, contributing technical expertise and leadership to establish robust systems and processes that will ensure long-term success for the facility.Key Responsibilities:Leadership and Team Development

• Provide leadership, direction, and governance for the QC Systems and Compliance team to ensure operational and scientific excellence.

• Recruit, develop, and mentor team members, fostering a culture of growth and technical capability within the team.

• Develop future leaders within the QC function, ensuring the team has the skills and knowledge to succeed.

Ownership of QC Programmes

• Lead and manage key QC programmes, including equipment qualification, electronic systems support, personnel qualification, and inspection readiness.

• Act as the technical expert on regulatory requirements related to QC operations, ensuring all systems adhere to global compliance standards.

Operational and Regulatory Expertise

• Provide technical guidance on QC operations, focusing on electronic systems and data integrity requirements.

• Implement lean principles and a Digitally Native approach to ensure both operational efficiency and regulatory compliance.

Start-up Leadership

• Collaborate closely with the project team during the start-up phase to influence decisions and strategies that align with the facility’s long-term goals.

• Build the organisation’s capability, capacity, and culture to ensure the site operates at the highest level of excellence.

• Leverage internal knowledge and external best practices to develop and implement effective QC systems and processes.

Business and Site Management

• Take on broader site and business management responsibilities, in line with the Associate Director role across the site.

• Support the project team to deliver the facility and ensure all systems are aligned with regulatory and operational objectives.

Basic Requirements:

• Education: BSc (Hons), MSc, or PhD in Chemistry, Biochemistry, Microbiology, or related discipline.

• Experience: Minimum of 8 years’ experience in a GMP pharmaceutical or biologics laboratory environment.

• Leadership: At least 2 years of experience leading cross-functional teams.

• Technical Expertise: In-depth knowledge of regulatory requirements for QC operations, equipment qualification, and data integrity.

Why Join Our Client?This is an exciting opportunity to take the next step in your career, joining a world-class organisation where you can shape the future of QC systems and compliance. As the Associate Director, you will have the autonomy to lead a talented team, influence key decisions, and drive operational excellence in a dynamic, forward-thinking environment.Community and Quality of Life in County LimerickLocated in the heart of County Limerick, this role offers the chance to live and work in a vibrant community, surrounded by stunning landscapes, with an exceptional quality of life and easy access to cultural, recreational, and educational amenities.How to Apply:If you are a proven leader with expertise in QC systems and compliance, and you’re ready to take on an exciting new challenge in a world-class organisation, we encourage you to apply today. Don’t miss this opportunity to make a lasting impact in the pharmaceutical industry and grow your career in an inspiring and supportive environment.“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing RecruitersFor further information on this role please contact Lisa Lawlor on 0868395533 /Check out all our open jobs on our HERO Recruitment website –Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”

Expected salary

Location

Limerick

Job date

Sat, 07 Sep 2024 05:59:12 GMT

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