LTSS Service Coordinator managing member care plans and assessments in Ohio for chronic illnesses. Focusing on person - centered care through face - to - face and telephonic interactions with 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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