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.

Based in Dublin, Ireland; 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.

The Role Overview:

This Quality Systems Manager role is a 12-14 month fixed term contract. The role will provide Quality Systems leadership and oversight, ensuring Quality Management System (QMS) processes, records and computerised systems remain compliant with applicable GMP, GDP, Data Integrity and internal requirements.

The successful candidate will combine strong pharmaceutical quality systems experience with technical knowledge of electronic Quality Management Systems (eQMS), data integrity, validation, and continuous improvement.

The Quality Systems Manager will support in Quality Operations where required.

Duties and Responsibilities:

• Manage and continuously improve elements of the electronic quality management system (eQMS) in accordance with applicable requirements and company procedures.
• Monitor quality system performance and identify adverse trends, recurring issues, and opportunities for improvement through Quality Metrics.
• Assist in ensuring the company is inspection ready at all times (Regulatory Agencies and Client)
• Serve as a Quality Systems subject matter expert for eQMS
• Support the administration, governance, maintenance, and continuous improvement of quality workflows within the eQMS.
• Manage user access, permissions, configuration changes, testing and associated system documentation.
• Partner with Quality, IT, Service Providers, and business stakeholders on eQMS changes, enhancements, upgrades, and system improvements.
• Support the development and maintenance of Power BI quality dashboards, including KPI design, reporting requirements and data review.
• Ensure eQMS workflows and associated processes remain aligned with approved procedures and GxP requirements.
• Support user requirements, workflow design, system testing, change control, and implementation activities.
• Develop and monitor eQMS reports, dashboards, KPIs, and quality-system trending, as applicable.
• Support investigation and resolution of quality-system issues affecting the eQMS or related GxP applications.
• Provide Quality oversight and support for the validation and lifecycle management of GxP computerized systems.
• Review and/or approve CSV documentation, as appropriate
• Ensure computerized systems are maintained in a validated state throughout their lifecycle.
• Apply a risk-based approach to computerized system validation and changes.
• Support assessment of system changes to determine validation impact and required testing.
• Conduct and Support internal audits, regulatory inspections, customer audits, and partner audits.
• Provide documentation and subject matter expertise during inspections and audits.
• Maintain awareness of evolving regulatory expectations and industry practices relating to pharmaceutical quality systems, data integrity, computerized systems, and electronic records.
• Qualification and Management of assigned Service Providers including periodic reviews of suppliers and service providers.
• Escalate significant quality or compliance risks to the Senior Quality manager and / or Responsible Person.
• Managing Deviations, CAPAs, Change Controls and Quality Risk Assessments where applicable.
• Support Management Review through preparation and analysis of quality performance data, KPIs, trends, and significant quality issues.
• Lead cross-functional quality initiatives and improvement projects.
• The Quality Systems Manager will also support Quality Operational activities from time to time, such activities include but not limited to:
  • Perform transport duty of care and release for acceptance checks as necessary
  • Review batch documentation and associated quality records to support batch acceptance and product disposition activities.

Education and Experience:

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

• At least 5-7 years of experience in positions of responsibility within Quality Assurance
• Experience with documentation systems, document review and auditing responsibilities
• Knowledge of relevant regulations, including EU / FDA GMP and / or GDP standards desirable
• Experience with Document Management and Training Management processes within a regulated QMS.
• Experience conducting, participating in or supporting Internal, Supplier and External Audits.
• Administrator Experience using an electronic Quality Management System (eQMS); TrackWise Digital experience desirable.
• Must be a proactive problem solver, well organized, team player with good follow-through
• Must be able to handle and prioritize multiple responsibilities and meet deadlines in a fast-paced environment.
• Experience monitoring, analysing and trending quality metrics and KPIs.
• Knowledge of data integrity, GAMP 5 and EU GMP Annex 11 principles.
• Experience with supplier qualification, supplier oversight and review of third-party assurance documentation.

Pay Range

The typical pay range for this role is: