Quality Control Lead

Description Quality Control Lead About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity The Quality Control Lead role is responsible for overseeing the daily operations of the QC team. This role involves managing a team of QC Staff (microbiologists, biochemists and general staff) coordinating activities, and implementing policies and procedures to enhance operational efficiency. The Quality Control (QC) Lead ensures that all materials, in-process samples, drug substance, and sterile drug product meet defined quality standards and regulatory requirements prior to release. In a sterile environment, the QC Lead’s primary focus is safeguarding aseptic quality through robust microbiological oversight, sterility assurance testing, environmental monitoring, and data integrity across laboratory operations. The role provides strategic and operational leadership for QC laboratories—analytical and microbiology—covering method lifecycle, stability, contamination control verification, and inspection readiness. The QC Lead drives compliance with cGMP/GLP, EU GMP Annex 1 (sterile manufacturing), Annex 15, USP/EP, and ICH guidance, ensuring timely, accurate results and continuous improvement in support of patient safety. The position will be responsible for managing, coaching and developing all aspects of these functions with input and local accountability for strategy, forward planning, safety, quality, delivery, cost and service performance. Responsibilities

• Leadership & People Development: Lead and inspire the QC team with clear ownership, accountability and cross-functional collaboration; develop future leaders, SMEs and high-performing teams through coaching, feedback and challenging goals while fostering a strong, engaged and psychologically safe culture.
• Operational & Performance Excellence: Deliver departmental QC objectives, stable supply and multi-project execution; resolve problems, drive continuous improvement, set ambitious targets, manage KPIs and action plans, and ensure talent is aligned to current and future business needs.
• Compliance & Quality Assurance: Ensure full compliance with corporate policies, GMP/GDP, GLP, environmental and safety regulations; maintain audit readiness, deliver successful audits, deploy best practices and issue timely regulatory and performance reporting.
• Strategic Alignment & Business Growth: Contribute to site and global strategic planning, support new product and technology negotiations, deliver strategic projects on aggressive timelines, identify growth opportunities and translate long-term vision into actionable outcomes.
• Organisation, Culture & Global Integration: Build a best-practice QC organisation with strong infrastructure, innovation and quality focus; attract and retain talent, develop early-career pipelines, strengthen global partnerships and deputise for the Head of Engineering & QC as required.
• Technology, Change & Business Continuity: Lead technology adoption and change initiatives across products, systems and processes; maintain critical technical knowledge, manage risk and crisis response, support business continuity planning and ensure readiness for future growth.

Education

• Bachelor’s degree (or equivalent) in a Scientific discipline or proven relevant in-depth experience.

Preferred Experience

• Experience & Technical Expertise: Extensive experience in a similar role (cGMP start-up experience advantageous), with strong technical competence, validation leadership capability and commitment to continuous professional development and improvement.
• Project & Delivery Capability: Proven ability to independently progress multiple technical projects, lead or contribute significantly to cross-functional teams, and deliver commissioning, implementation and maintenance support within a cGMP manufacturing environment.
• Personal Effectiveness & Adaptability: Excellent organisational and communication skills, able to prioritise and shift focus as needs change, work effectively both independently and collaboratively, and remain open to new ideas and approaches.

Additional Information

• This is a permanent full-time position.
• Position is based in Tralee – Ireland.
• This position requires you to be 100% on site / in the office.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.