Quality and Compliance Manager

5 days ago

Dublin, Dublin City, Ireland Steripack Full time

Our client is an established global pharmaceuticals distributor seeking an experienced and highly motivated Quality and Compliance Manager to join the team at the Dublin site.

This role involves overseeing and continuously monitoring the QMS, andis key in ensuring compliance with relevant legislation, cGxP guidelines, ethical code requirements, and corporate standards acrosspharmaceutical and medical device operations.

Key Responsibilities:

  • Lead the development and continuous improvement of the Quality Management System to meet regulatory, ethical, and internal standards.

  • Champion ethical code implementation and help embed a compliance-focused culture across the business.

  • Lead quality and management review meetings and report on QMS performance and trends.

  • Ensure QMS processes are efficient, compliant, and well-understood across the organization.

  • Oversee GDPR compliance activities and support related corporate initiatives.

  • Develop and deliver training and coaching on cGxP, ethical codes, and quality systems.

  • Promote risk-based thinking and manage change controls.

  • Track deviations and ensure timely follow-up on CAPAs.

  • Manage supplier qualifications, contracts, and ensure technical agreements align with internal SOPs.

  • Oversee internal and external audit schedules and act as a key contact during audits.

  • Act as internal and external auditor as required.

  • Prepare and maintain documentation in line with GDP and other relevant regulatory standards.

  • Act as Deputy Responsible Person (RP) under the Wholesale Distribution Authorisation (WDA), and as RP during absences.

  • Ensure ongoing compliance with Medical Device Regulations.

  • Collaborate with the Local Drug Safety Unit Manager to integrate pharmacovigilance SOPs into the QMS.

  • Contribute to PV audit schedules, deviation management, and performance reviews.

  • Support the setup and regulation-compliant operation of the Consumer Healthcare division.

Desired Experience and Qualifications:

  • Degree in life sciences or a related discipline.

  • 3+years' experience in a quality role within the pharmaceutical or medical devices industry.

  • Strong understanding of GDP requirements (additional regulatory knowledge is a plus).

  • Committed to regulatory compliance, scientific quality, and ethical integrity.

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