OverviewQuality & RA Compliance CMO Manager - HybridJoin to apply for the Quality & RA Compliance CMO Manager - Hybrid role at HRM.This multinational pharmaceutical and biotechnology corporation is a leading producer of therapeutics with upwards of 70,000 employees and revenues above 10 billion per annum. The organization has expanded in Ireland to include significant manufacturing operations and key global roles responsible for the contract manufactured product portfolio. The role is remote/hybrid and sits within the External Quality Group as a senior end Quality contractor and will also serve as the Regulatory interface between Contract Manufacturing Operations, Quality and Internal Regulatory Affairs.ResponsibilitiesManage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers in accordance with established procedures.Assess the quality of external suppliers’ products and processes and ensure product specifications are met and quality systems are maintained.Support internal and external partners with auditing activities related to external supply activities and activities at a portfolio of contractors as applicable.Support Compliance Assessments to ensure current GMP/GDP adherence.Manage risk at vendors by implementing Quality Improvement Plans and supporting risk assessments.Support onboarding activities for new CMOs or product launches within the portfolio as applicable.Support offboarding activities for exiting CMOs/products/SKUs within the portfolio as applicable.Make product quality decisions leveraging knowledge of Quality/Manufacturing principles while ensuring compliance with global regulatory and business requirements.Influence quality decision making in line with industry and business requirements.Provide Quality Leadership within cross-functional virtual site operating teams.Partner with colleagues to develop and negotiate quality agreements.Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports and relevant product stability reports.Identify, develop and implement continuous improvement initiatives related to external quality processes to ensure compliance with current standards.Ensure tracking and documentation of all required quality actions in relevant systems and follow escalation processes as needed.Lead and support complex investigations, market complaints, risk assessments and other activities in support of products within the portfolio.Provide performance metrics for key performance indicators.Work independently, receiving instructions primarily on unusual or complex problems.ExperienceMinimum Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline.Minimum 5 years' experience in Pharmaceutical or Biotech Quality Assurance roles with direct responsibility for product quality decisions.Experience with external suppliers/contractors.Advanced computer skills for MS Office and enterprise systems such as SAP, QTS, Vault.Demonstrated ability to lead virtual teams and cross-functional projects/initiatives.Demonstrated experience managing complex quality and compliance activities.Knowledge of US, European and global cGxPs, compliance issues, inspectional trends, and industry quality assurance practices.Experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role.How to discover moreTo discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.Job DetailsSeniority level: Mid-Senior levelEmployment type: ContractJob function: Quality Assurance and ScienceIndustries: Pharmaceutical ManufacturingLocation: Dublin, County Dublin, Ireland
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