Associate Director of Quality

Collins McNicholas Recruitment; Cork; On-site; EUR 80,000 - 120,000; Full time

Job summary

A leading medical device organization in Cork is seeking an Associate Director of Quality. The successful candidate will be responsible for ensuring quality and regulatory compliance for pharmaceutical products, providing expert leadership, and managing quality systems. With over 10 years of experience in the industry, candidates with strong knowledge of compliance standards and a passion for quality assurance are strongly encouraged to apply.

Qualifications

• 10+ years in pharmaceutical or biotech production.
• 5 years in managerial or leadership role.
• Strong knowledge of cGMP, ICH standards, EU GMP, FDA/HPRA requirements.

Responsibilities

• Serve as subject matter expert in pharmaceutical quality.
• Ensure quality system activities align with compliance requirements.
• Lead audit teams and coordinate with departments.

Skills

Quality Assurance

Quality Control

Regulatory Compliance

Leadership

Education

Bachelor’s degree (Level 8) in Science or Engineering

Master’s degree or higher (Level 9)

Job description

A new opportunity has arisen for an Associate Director of Quality to become part of a top-tier medical device organisation headquartered in Cork. This globally recognised company is a leader in its sector and is expanding its local operations. The Associate Director of Quality is responsible for delivering expert guidance on quality and regulatory compliance to ensure that all pharmaceutical products produced and distributed by the company adhere to the strictest standards of safety, quality, and legal requirements. This is a permanent position.

Role Responsibilities:

• Serve as a subject matter expert in pharmaceutical quality and compliance.

• Provide functional leadership, including effective allocation and management of departmental resources to meet business goals.

• Ensure all quality system activities align with compliance requirements and organisational objectives.

• Lead audit teams and coordinate with cross-functional departments to address findings and implement effective corrective actions.

• Act as a key interface with external regulatory bodies and support audits or inspections as needed.

• Oversee and manage the Pharmaceutical Quality Management System & Continuous Improvement

• Ensure that all products meet applicable industry regulations and quality standards.

• Support the site Qualified Person (QP) and act as a backup QP as required.

• Review pharmaceutical products and ensure their release complies with all relevant regulatory standards.

• Work closely with the NPI team to ensure that new product designs, formulations, and processes are developed in alignment with current Good Manufacturing Practices (cGMP) and regulatory guidelines.

Role Requirements:

• Bachelor’s degree (Level 8) in Science or Engineering (Master’s degree or higher, Level 9, is an advantage).

• 10+ years in pharmaceutical or biotech production, with a strong background in Quality Assurance (QA), Quality Control (QC), or Compliance.

• At least 5 years in a managerial or leadership role in a quality-focused function

• Strong knowledge of cGMP, ICH standards, EU GMP Annexes, and FDA/HPRA requirements.

• Experience as QP is an advantage

For a confidential discussion and more information on the role of Associate Director of Quality, please contactAlicja Burchardt.

[e-mail]

0212427109