Director of Quality Assurance

Careerwise Recruitment; Galway; Presencial; EUR 120.000 - 150.000; Jornada completa

Descripción de la vacante

CareerWise Recruitment is seeking a Director of Quality Assurance (QP) for a Galway-based client. You will lead two critical QA functions: Batch Release and CAPA, ensuring all drug products meet regulatory and internal standards while driving investigations and continuous improvement.

You will mentor teams, uphold QA excellence, and serve as Senior Director designee when required. The role requires QP certification, strong regulatory knowledge (FDA, EMA), aseptic manufacturing expertise, and a

Formación

• QP certification required.
• Experience with regulatory audits (FDA/EMA) and GMP.
• Aseptic manufacturing and cGMP knowledge.

Responsabilidades

• Provide strategic and operational leadership to Batch Release and CAPA teams.
• Direct quality oversight of product release, change control, CAPA, deviation management, and risk assessments.
• Oversee QMS maintenance and act as Senior Quality Approver.
• Lead inspections and audits; ensure audit readiness.
• Drive continuous improvement in QA systems and processes.
• Mentor and develop QA teams and foster accountability and collaboration.

Conocimientos

Leadership

Regulatory knowledge

Communication

Educación

BSc in Pharmacy / Chemistry / Microbiology

Advanced degree (M.S./Ph.D./MBA) preferred

Descripción del empleo

A Director of Quality Assurance (QP) is required by CareerWise Recruitment for our Galway based client. As Director of Quality Assurance, you will be responsible for managing Quality teams support operations and release, providing oversight of all quality assurance activities within a sterile manufacturing facility. This role ensures that all products meet internal and external standards, comply with cGMP regulations, and fulfill regulatory and customer requirements. meet the highest standards of safety, quality, and efficiency.

SYNOPSIS:

• You will be responsible to lead and oversee two critical functions within the Quality Assurance (QA) organization: the Batch Release Team (manufacture and packaging), quality incoming inspection and the Investigations & Corrective and Preventive Actions (CAPA) Team.
• This role ensures all drug products are released in compliance with regulatory requirements and internal quality standards, while driving timely, effective investigations and robust CAPA execution to support continuous improvement and inspection readiness.
• You will be responsible for building strong people leadership and development.
• The successful individual will be responsible for building and nurturing high-performing teams, fostering a culture of collaboration, accountability, and continuous improvement.

THE ROLE:

• Support and lead the Qualified Persons (QP), provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards (FDA, HPRA, DERKA, etc.).
• Manage the teams’ activities and develop strong decision makers and mentor site, fostering a culture of accountability, collaboration, and quality excellence. Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.
• Oversee the implementation and maintenance of the Quality Management System (QMS), serve as a senior Quality Approver.
• Lead inspections and audits by regulatory authorities and ensure audit readiness at all times. Support self-inspection programs, to proactively drive continuous improvement initiatives in QA systems and processes.
• Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manuals
• Collaborate cross-functionally with Manufacturing, Packaging, Quality Control, R&D, Regulatory Affairs, Supply Chain and Global verticals to ensure cohesive quality operations.
• Monitor, analyze, and report quality metrics and key performance indicators (KPIs) to senior leadership, driving data-informed decision-making.
• Lead, mentor, and develop the Quality Assurance (QA) team to support a high-performance and continuous improvement culture.
• Act as Senior Director designee when required.

REQUIREMENTS:

• QP certified, Bachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.
• Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
• Aseptic manufacturing expertise, proven experience in contamination control strategies
• Extensive experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
• Demonstrated ability to manage multiple strategic and operational priorities in a fast paced environment
• Strong problem solving and critical thinking skills
• Excellent communication, writing, presentation and data organisation skills
• Demonstrated interpersonal and leadership qualities