GMP Quality Manager

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.

Position Summary

The Quality Manager is accountable for ensuring that all Manufacturing and CMO activities are conducted in full compliance with Good Manufacturing Practices (GMP), local regulatory requirements, and the conditions set out within Quality Agreements.

The role is responsible for overseeing manufacturing activities with suppliers and supports the Quality compliance onsite. The Quality Manager oversees the Quality Management System (QMS) for GMP / GCP operations, ensuring it is maintained, effective, and continuously improved. The Quality Manager provides quality leadership, governance, and assurance across CMO-related activities, supporting a sustainable culture of compliance and inspection readiness

Key Responsibilities:

• Assist in Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training)
• Collaborate with team members on the implementation and management of GXP quality and compliance systems and policies, including the development of QA and GMP / GDP processes and procedures
• Assist in ensuring the company is regulatory inspection ready at all times (Regulatory Agencies and Client)
• Review drug substance, drug product, Finished product executed batch records. Collaborate with CMOs to resolve issues, and support release of product.
• Perform transport duty of care and release for acceptance checks as necessary
• Support approaches to implement quality standards and procedures for GXP regulatory compliance to meet company needs
• Oversee performance of Suppliers and Service Providers
• Conduct supplier qualification and quality audits of CMOs, including audit follow up, review of observation responses, CAPA management, and tracking.
• Support development of Quality Agreements with CMOs
• Collaborate with team, regulatory, and client representatives in audits and inspections
• Provide guidance and training to cross-functional departments on relevant GMP regulations and guidelines.
• Support the implementation and utilization of electronic document management system(s).
• Represent Quality on cross functional project teams to ensure adherence to cGMP and compliance standards.
• Conduct internal and external audits to ensure compliance with GCP regulatory requirements and GMP regulatory requirements for commercial drug manufacturing, and ensure corrective actions are implemented to resolve audit findings
• Managing regulatory change control processes in the QMS
• Maintain pertinent domestic and international regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Collaborating with the external publishing vendor for e-submission files and compendia submission
• Assist Complaint Investigations with Manufacturing sites and distributors.
• Performance of Annual Product Quality Reviews
• Execution on Quality System tools: Change Controls, Deviations, CAPAs, Risk Assessments
• Leads QA function product launches prior to distribution of the product
• QA Oversight of artwork changes.

Qualifications, Experience and Skills:

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

• 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 FDA, EU GMP (ideally sterile manufacturing)
• Must be a proactive problem solver, well organized, team player with good follow through
• Strong background in Quality Management Systems ideally eQMS,
• Must be able to handle and prioritize multiple responsibilities and meet deadlines in a fast paced environment.
• Understanding of virtual wholesaling and CMO oversight.

Pay Range

The typical pay range for this role is: