We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time.

Cordavis is a wholly owned subsidiary of CVS Health.

Cordavis makes strategic investments to bring pharmaceutical products to the U.S. market to increase competition and lower costs. Cordavis partners with manufacturers and payors to deliver:

Sustainable cost savings for payors and patients.
A reliable and predictable supply chain that minimizes disruption for patients.
A responsible and viable long-term approach to deliver value and affordable products.

Our partnerships create a vibrant and competitive marketplace, allowing us to expand our investments in future products to shape tomorrow's health care, today.

Position Summary

The Quality Manager and Responsible Person is accountable for ensuring that all distribution activities are conducted in full compliance with Good Distribution Practices (GDP), local regulatory requirements, and the conditions of the Wholesale Distribution Authorisation (WDA). The role is formally listed as the Responsible Person on the WDA and holds responsibility for regulatory compliance, quality oversight, and the integrity of the distribution supply chain.

The role acts as the primary point of contact with the Health Products Regulatory Authority (HPRA) and freight forwarders for all matters relating to the WDA and distribution activities. The QA Manager / RP oversees the Quality Management System (QMS) for GDP operations, ensuring it is maintained, effective, and continuously improved. The Quality Manager / RP provides quality leadership, governance, and assurance across distribution and CMO‑related activities, supporting a sustainable culture of compliance and inspection readiness.

Responsible Person (RP) Responsibilies:

Ensuring that the operations do not compromise the quality of medicines by ensuring that appropriate systems are in place throughout the supply chain
Ensuring that the conditions and authorized activities of the WDA and GDP guidelines are being followed and adhered to.
Interaction with Health Products Regulatory Authority (HPRA) in relation to licence application and on-going maintenance of Wholesale Distribution Authorisation (WDA).
Ensuring that the Pharmaceutical Quality System (PQS) is implemented and maintained in compliance with GDP requirements, and shall have personal oversight of the PQS.
Approval of all GDP related procedures.
Oversight of the approval of all GDP related suppliers and customers including approval of any subcontracted activities which may impact GDP.
Ensuring that any GDP deviations/non-conformances are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
Oversight of change control proposals (third party contractors and internal) and action plans.
Lead inspection readiness activities in relation to GDP at all times.
Preparation for, participation in and follow up on inspections by regulatory authorities.
Ensuring that relevant customer complaints are handled appropriately.
Oversight and approval of any decision to recall product.
Involvement in any decision to quarantine or dispose of returned, rejected, expired, recalled or falsified medicinal products and oversee destruction of any returned product arising from a product retrieval/recall or product complaint.
Approving any returns to saleable stock.
Ensuring self-inspections are performed and an approved schedule at defined intervals and that necessary corrective actions are implemented.
Ensuring that relevant GDP personnel are trained in the GDP duties assigned to them, that training effectiveness is assessed, as appropriate, and that continuous training plans are maintained.
Leading the annual Quality Management Review (aligned with scope of WDA) and co-ordination of any actions from this meeting for implementation.
Review of performance metrics for suppliers which are subject to the WDA at periodically held Quality Management Review meeting.
Ensuring Quality Agreements are in place with all GDP related suppliers.
Oversight of the management, storage and control of quality records and that records are maintained in a secure manner and are available/retrievable.
Ensuring that any additional requirements imposed on certain products by national law are adhered to.
Maintaining records of any RP delegated duties.

Required Qualifications
Minimum of a Bachelors’ degree, ideally in a bio-chemistry, life sciences, or microbiology related field; Advanced degree will be given preference, however, extensive industry experience acceptable in lieu of advanced degree

Preferred Qualifications
Bachelors’ degree, ideally in a bio-chemistry, life sciences, or microbiology related field; Advanced degree will be given preference, however, extensive industry experience acceptable in lieu of advanced degree

Education
Bachelors’ degree, ideally in a bio-chemistry, life sciences, or microbiology related field;

Pay Range

The typical pay range for this role is:

€50,000.00 - €125,000.00

We anticipate the application window for this opening will close on: 31/05/2026

Mgr,Quality (IC)

Job Description