A new opportunity has arisen for an Associate Director of Quality to become part of a top-tier medical device organization headquartered in Cork. This globally recognized 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 organizational 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, please contactAlicja Burchardt
alicja.burchardt@collinsmcnicholas.ie
0212427109
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