Job Title : TSA Manager Location : Sligo, Ireland Reports To : TSA Director About the Role We are seeking a Technical and Scientific Affairs (TSA) Manager to join our dynamic team in Sligo.
As a key member of the Site Leadership Team, you will lead the execution of the technical agenda, including Technology Transfer , Process Validation , Cleaning Validation , Manufacturing Operations , and Research & Development Activities where required.
This is a senior technical leadership role where you will not only oversee TSA resources but also collaborate with peers to drive an expanding and complex technical agenda.
Key Responsibilities Lead and develop the TSA team, ensuring technical expertise and leadership in process investigations, root cause analysis, CAPAs, process improvements, and change control approvals.
Drive the implementation of new production methods, including Technology Transfer , production method validation, and team training.
Lead problem-solving initiatives and foster a culture of continuous improvement.
Collaborate with National Authorities on specific regulatory matters, such as importation of animal-origin or pathogen materials.
Contribute to the company's strategic direction as part of the management team and participate in professional forums.
Build functional partnerships across business units and engage with TSA teams in other locations to share knowledge and best practices.
Support site audits and ensure compliance with all Safety, Health, and Welfare legislation and company policies.
Education & Qualifications A minimum of a Master's degree in a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals).
A PhD is desirable.
Experience 10+ years in the biotechnology and/or pharmaceutical industry, with experience in new product introductions and ongoing product support.
5+ years of leadership experience, managing direct and/or matrix teams.
Deep knowledge of pharmaceutical manufacturing processes and equipment, with expertise in oral solid dose, parenterals, and/or biologicals.
Experience in vaccines and product development is a plus.
Proven ability to prioritize short-term and long-term goals and adapt to dynamic business needs.
Demonstrated success in coaching and mentoring technical teams.
Core Competencies Strong leadership and team management skills.
Expertise in GMP, ICH, and regulatory guidance.
Excellent problem-solving, risk management, and decision-making capabilities.
Proactive in staying current with industry advancements and technologies.
Exceptional communication and collaboration skills.