Quality Manager

2 weeks ago

Dublin, Ireland Cpl Full time

Quality Manager

Duties and Responsibilities:

  • Assist in the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as client programs transition from early phase to commercial development/manufacturing, to release readiness
  • Collaborate with team members on the implementation and management of GXP quality and compliance systems and policies, including the development of QA and QC processes and procedures
  • Ensure the company is regulatory inspection ready at all times (Regulatory Agencies and Client)
  • Where assigned, manage as the primary point of contact for internal and regulatory agency inspections
  • Review drug substance, drug product, and labelled product executed batch records. Collaborate with CMOs to resolve issues, and support the release of products.
  • 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
  • Conduct supplier qualification and quality audits of CMOs, including audit follow-up, review of observation responses, CAPA management, and tracking.
  • Support the development of Quality Agreements with CMOs
  • Where assigned, host regulatory and client representatives in audits and inspections
  • 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/GDP 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 databases 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

Education:

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

Experience:

  • At least 8 years of experience in positions of responsibility within Quality Assurance. Experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections.
  • Experience with documentation systems, document review, and auditing responsibilities
  • Knowledge of relevant regulations, including FDA
  • Must be a proactive problem solver, well organized, team player with good follow through
  • Microsoft Excel, Word, and Access experience is required. 
  • Must be able to handle and prioritize multiple responsibilities and meet deadlines in a fast-paced environment.

About Cordavis

We supply safe, affordable medications to the U.S. market through our partnership with FDA-approved pharmaceutical manufacturers. Our top priority is to guarantee quality control and global supply chain continuity as we commercialize Cordavis branded products. We are committed to equal employment opportunities for employees and job applicants in compliance with applicable law and to an environment where employees are valued for their differences.

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