This company is one of the world's leading pharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts more than 10,000 employees, and offices in more than 40 countries globally. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to meet significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today and building their pipeline through research and development and business development delivering access in the future for patients. HRM has been exclusively retained to manage a search for an exciting new position which has arisen in the organisation for a Quality CMO Manager reporting directly to the Senior Director in the U.S.

The Role

• Provide oversight for assigned CMOs and/or product lines and Quality staff, including but not limited to:
• • Change management
  • Investigations (process, complaint, and laboratory)
  • Product release
  • Annual Product Review
  • Management Review (as applicable)
  • Master documents (batch records, methods, labels, etc…)
  • Design History File (as applicable)
  • Device History Record (as applicable)
  • Validation protocols and reports
  • Stability data review / stability coordination
  • CAPA

• As the RP, held accountable for ensuring the quality and traceability of medicinal products are maintained within the supply chain and maintains responsibility for the compliance with the WDA.
• Provide quality, compliance and business strategy for major initiatives
• Assign resources to projects and organize work / provide guidance to direct reports
• Support CMO audits and supports audits as part of the audit team as necessary
• Identify, develop and execute project plans and timelines to achieve desired results
• Champion continuous improvement efforts for projects identified at the CMOs or within Mallinckrodt
• Participate actively on cross-functional support and process improvement teams
• Seek to identify and execute safety improvements and waste minimization opportunities
• Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with CMO management and oversight
• Plan, execute and follow up on CMO site visits due to identified issues, validation/transfer activity or as routine periodic visits
• Ensure material review board (MRB), Biological Product Deviation Reports (BPDR) and field alert report (FAR) decisions are appropriately made and executed, including follow up investigation
• Support CMOs with FDA and other regulatory body investigations and inquiries as needed
• Design and monitor Key Performance Indicators (KPI) and develop and monitor staff goals accordingly
• Provide leadership to QA staff, as assigned; including goal setting, work assignment/prioritization, issue resolution, and personnel development
• Evaluate and provide QA recommendations on all products, systems and issues that are/may be affected by regulatory or cGMP requirements.

The Person

• Minimum BS in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies
• Advanced degree preferred
• Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
• Certification as a Quality Auditor or Quality Manager helpful

• Minimum 5 years' experience in a quality engineer or equivalent role
• Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
• Preferred experience including, but not limited to the following:

• Application of cGMP to manufacturing and testing
• Product release and investigations
• Change Management and CAPA
• FDA inspections / Regulatory Affairs
• Validation
• Statistical techniques

For more, Please contact Emma Mullen on +353 87 636 9263