My client, a global Biopharmaceutical company in Cork, is recruiting for a Senior QA Manager position. This is a full time permanent position based in the company’s Commercial Manufacturing & Packaging Facility.
- Ensures quality oversight of commercial and/or development products at CMOs
- Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub-functions
- Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on development programs
- Ensures that performance and quality of drug products conform to established standards and regulatory agency requirements.
- Assure CMO’s meet the company’s quality, regulatory and compliance standards, in order to ensure a sustainable delivery of quality product to patients and maintain a good working relationship
- Reviews regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections
- Collaborates, engages and works cross-functionally with other Quality groups
- Acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
- Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
- Quality Risk Management, identifying key risks impacting commercial and development programs
- Competent in execution and responsible for translating quality strategy into plans of action.
Education & Experience:
- Significant years of relevant experience and a Bachelor’s degree in science or related fields or advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- Prior people management experience is beneficial.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Biopharmaceutical and/or Pharmaceutical experience preferred.
- Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance, understanding of Parenteral and Aseptic processing. OSD and Biopharmaceutical operations is beneficial.
- Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing
- Participates in compliance audit as required
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671