Director of Quality Assurance (QP)

CareerWise Recruitment; Galway; In loco; EUR 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

CareerWise Recruitment in Galway is seeking a Director of Quality Assurance (QP) to lead quality operations in a sterile manufacturing facility. You will oversee Batch Release and CAPA teams, ensuring products meet cGMP and regulatory requirements while driving continuous improvement.

The role demands strategic leadership, hands-on QA expertise, and strong collaboration with Regulatory Affairs, Manufacturing, R&D and Supply Chain.

Competenze

• QP certified with BSc in Pharmacy/Chemistry/Microbiology or related field; MS/PhD preferred.
• Extensive experience in sterile drug manufacture and cGMP.
• Strong leadership, strategic and regulatory audit experience.

Mansioni

• Lead Batch Release and CAPA teams and QA operations.
• Ensure regulatory compliance and audit readiness.
• Oversee the Quality Management System (QMS) and document control.
• Collaborate with Manufacturing, Regulatory Affairs, R&D and Supply Chain.
• Mentor and develop the QA team; report KPIs.

Conoscenze

Leadership

QA management

Regulatory knowledge

Aseptic manufacturing

Data analysis

Formazione

BSc in Pharmacy/Chemistry/Microbiology or related

MS/PhD in a related field

Strumenti

QMS software

Audit management

Descrizione del lavoro

Job Description

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.

Role of this position

• 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.

Job 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