Quality & RA Compliance CMO Manager - Hybrid
This multinational pharmaceutical and biotechnology corporation is a leading producer of therapeutics with a substantial global footprint and a focus on cGxP compliance. The role is a remote/hybrid senior end Quality contractor within the External Quality Group, serving as the regulatory interface between Contract Manufacturing Operations, Quality and Internal Regulatory Affairs.
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 suppliers' products, processes and related documents while ensuring 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 supporting risk assessments.
* Support onboarding activities of 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 comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas 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 the latest internal and external standards.
* Ensure adequate tracking and documentation of all required quality actions in the relevant systems and that escalation processes are followed.
* 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.
Experience
* Minimum Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline.
* Minimum 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 MS Office and enterprise systems such as SAP, QTS, Vault.
* Demonstrated 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 cGxP, 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 Shane Browne at HRM on +353 1 6321865 for a confidential discussion.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Quality Assurance and Science
Industries
* Pharmaceutical Manufacturing
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