Associate Director - QC Systems and Compliance

Associate Director - QC Systems and Compliance

About the Client:

I am seeking an exceptional candidate for my client, a prominent biopharma company based in Limerick, Ireland. They are currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility, which will be at the forefront of technological advancement. This state-of-the-art site will incorporate cutting-edge manufacturing technologies and advanced data collection and analysis platforms, aimed at enhancing safety, quality, productivity, and process performance. This is a unique opportunity to join the leadership team for the startup of this greenfield manufacturing site. The successful candidate will play a key role in establishing the organisation, facility, and culture to support a successful GMP operations startup.

Role Overview:

The Associate Director of QC Systems and Compliance will lead the QC Systems and Compliance team, which is responsible for managing cross-lab programs. These include electronic systems qualification, equipment qualification and management, personnel qualification, compendial updates, inspection readiness, and the oversight of shared lab equipment.

Key Responsibilities:

• Provide leadership, direction, and governance for the QC Systems and Compliance team to ensure operational and scientific excellence.
• Oversee QC program across all laboratories, including equipment and electronic systems, personnel qualification, and inspection readiness.
• Apply in-depth technical expertise in regulatory requirements related to QC operations.
• Demonstrate comprehensive knowledge of QC testing operations, including E-Systems and data integrity requirements.
• Recruit and develop team members to achieve scientific excellence.
• Cultivate the development of future leaders within the function and facility.
• Manage business, site, and team responsibilities in line with the Associate Director role.

During the startup phase of the Limerick site (2023 to 2025), the successful candidate will be expected to:

• Collaborate inclusively and energetically with the broader Limerick team.
• Provide technical guidance and build technical capability within the team.
• Develop the organisation with the necessary capability, capacity, and culture for operational excellence.
• Implement systems and processes for site operations, leveraging both existing knowledge and external insights.
• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
• Support the project team by providing feedback and collaborating on decisions and strategies to meet project deliverables and long-term strategic goals.

Essential Requirements:

• BSc (Hons), MSc, or PhD in Chemistry, Biochemistry, Microbiology, or a related discipline.
• A minimum of 8 years’ experience in a GMP pharmaceutical/biologics laboratory environment.
• At least 2 years of experience in leading a cross-functional team.

Desirable Skills:

• Business Knowledge: Proven high performance, initiative, and proactive problem-solving abilities. Strong self-management, prioritisation, and organisational skills.
• Learning Agility and Curiosity: Ability to adapt to ambiguity and uncertainty with a demonstrated capacity to identify, prioritise, and resolve problems effectively.
• Positive Influence: Capability to address and resolve issues, follow through on actions, and seek feedback for personal development.
• Relationship Building: Ability to establish and maintain key relationships at all levels within the organisation.
• Leadership: Proven skills in motivating and influencing teams, with a track record of effective leadership in a team environment.
• Communication: Strong communication skills, both written and verbal, in individual and group settings.
• Decision Making: Demonstrated ability to make informed decisions, gather necessary information, and ask relevant questions to reach optimal solutions.

If you are interested in this opportunity or know someone who might be a great fit, please get in touch. This role offers a chance to make a significant impact in a groundbreaking biopharma environment.

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