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Associate Director of Quality (GMP)

  • Sector: Science & Pharma
  • Contact Email: courtney.russell@collinsmcnicholas.ie
  • Job Ref: 23059

Excellent opportunity for an Associate Director of Quality Assurance (GMP) to join a Biologics Leader in the North East of Ireland. You'll oversee the GMP production quality system, ensuring compliance with regulatory and company standards, and establish effective monitoring structures. Additionally, you'll ensure consistent achievement of high-quality standards.

Overview of your responsibilities (full job description available on request)

  • Lead site QA for DS/DP manufacturing, overseeing quality monitoring and participating in GMP activities like process transfer and validation.
  • Monitor GMP production facility construction quality.
  • Support CQV activities as required.
  • Collaborate on SOP creation and alignment with WuXi corporate policies.
  • Audit departmental quality documents for data integrity and provide QA guidance.
  • Assist in site GMP Readiness and internal inspections.
  • Establish and manage DS/DP QA team, providing online support.
  • Coordinate with teams to support GMP production activities.
  • Conduct routine audits to ensure compliance with regulatory and company standards.

Knowledge, Skills and Experience Required for the Role:

  • Knowledge of legislative, regulatory, market, biologics, and data integrity requirements.
  • Ideally, a degree in Biopharmaceutical Science or related field.
  • Experience in vaccine/biopharma or similar pharma/science roles preferred.
  • Strong communication skills and ability to thrive in a matrix environment.
  • Demonstrated leadership with over 5 years of management experience.

For a confidential discussion and more information on the role contact Courtney Russell

courtney.russell@collinsmcnicholas.ie

+353 (0) 71 9108062