Quality and RA Compliance CMO Manager

This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world, with upwards of 70,000 employees and revenues above 10 billion per annum. In recent years, this market leader has expanded its footprint in Ireland, to not only include significant manufacturing operations, but additionally has started housing a number of key global roles responsible for the organisation's contract manufactured product portfolio. As a result of additional CMOs coming online, this world leader now requires a remote/hybrid working,
senior end Quality contractor
within the organisation's External Quality Group. Aside from its Quality responsibilities, this role will also serve as the Regulatory interface between the Contract Manufacturing Operations, Quality and internal Reg Affairs dept.

Responsibilities

• Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/product(s) according to established procedures.
• Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
• Support internal and external partners with auditing activities related to external supply activities, or activities at a portfolio of contractors as applicable.
• Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence.
• Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments.
• Support onboarding activities of new CMO's or product launches within the portfolio as applicable.
• Support offboarding activities for exiting CMO's/products/SKUs within the portfolio as applicable
• Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and business requirements.
• Influence quality decision making in line with industry and business requirements
• Provide Quality Leadership within the 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.
• Perform batch disposition endorsement.
• May Identify, develop and implement continuous improvement initiatives related to external quality processes to ensure compliance with the latest internal and external standards.
• Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed.
• Lead and support complex investigations, market complaints, risk assessments and others in support of products within your portfolio.
• Provide Performance Metrics for key performance indicators.
• Work independently, receive instructions primarily on unusual or complex problems.

Experience

• Minimum Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline.
• Minimally 5 years' experience in Pharmaceutical or Bio Quality Assurance roles with direct responsibility for product quality decisions.
• Experience with external suppliers/contractors.
• Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault.
• Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives.
• Demonstrated experience managing complex quality and compliance activities.
• Demonstrated knowledge of US, European and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices.
• Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role.

To discover more about this opportunity, apply now or contact Anita Osibuamhe at HRM on for a confidential discussion.