Responsable de Missions Audit clé dans l'audit légal et contractuel chez Exco Socodec. Supervisant les équipes et assurant la qualité des travaux, avec un portefeuille diversifié de clients.
About the role
- Manager, External Quality responsible for oversight of pharmaceutical manufacturing processes in North America. Ensuring quality compliance and building partnerships with external manufacturers.
Responsibilities
- Provide quality leadership and oversight of external manufacturers in the North America region.
- Ensure effective and compliant execution of quality systems at external manufacturing (EM) sites.
- Build relationships with internal and external partners.
- Prepare EMs for successful health authority inspections.
- Provide oversight for technology transfer and new product introduction activities.
- Participate in the onboarding, qualification, and ongoing monitoring of external partners.
- Partner with manufacturing sites to identify and resolve quality issues.
- Review and approve product disposition and documentation.
- Monitor quality performance through tracking of key performance indicators.
- Assess current quality systems and recommend improvements.
Requirements
- A minimum of a Bachelor’s or equivalent University Degree is required with a focus in engineering, science, or an equivalent technical discipline preferred.
- A minimum of 8 years working in QA and/or QC functions in pharmaceutical industry.
- Experience in biotherapeutic manufacturing.
- Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
- Experience with manufacturing-facing support of clinical or commercial manufacturing operations.
- Ability to work independently in support of a portfolio of products and suppliers.
- Ability to quickly process complex information and make critical decisions with limited information.
- Strong interpersonal, communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.
- Experience with cell culture, biotherapeutic drug substance manufacturing preferred.
- Experience working with external manufacturers preferred.
- Experience developing or reviewing electronic batch records preferred.
- Experience in development or application of digitally-integrated quality metrics preferred.
Benefits
- Equal Opportunity Employer
- Inclusive work environment
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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