Senior Vice President of Quality Assurance
1 week ago
The Vice President of Quality at Medella Life is responsible for ensuring the highest standards of quality across all operations. This role encompasses a wide range of responsibilities, including:
- Quality Assurance Review: Conduct thorough reviews of documentation and records, ensuring the appropriate disposition of products related to CMC/Development, Clinical, and Commercial Operations.
- Oversight of Third-Party Manufacturing: Manage quality oversight for external manufacturing, packaging, and testing laboratory sites to ensure compliance with industry standards.
- Complaint Investigation Management: Supervise the processes for investigating customer product complaints originating from Contract Manufacturing Organizations (CMOs).
- Quality Management System Compliance: Ensure adherence to and continuous enhancement of the Quality Management System (QMS).
- Travel Requirements: Engage in travel to third-party sites as necessary to fulfill job responsibilities.
- Team Leadership: Lead and manage the Quality Team, fostering a culture of excellence and accountability.
To be considered for this role, candidates must meet the following educational and experiential criteria:
- Educational Background: A Bachelor’s degree in a scientific discipline is required; a Master’s degree is preferred.
- Professional Experience: A minimum of 10 years of experience in pharmaceutical and/or medical device environments is essential.
- Quality Support Expertise: Proven experience in providing quality support for both pre-commercial Clinical R&D/CMC and Commercial Operations.
- Combination Device Experience: Familiarity with combination devices that integrate pharmaceutical and medical device elements.
- Collaboration with External Partners: Experience working with CMOs, CROs, CTLs, and other business partners is required.
- Regulatory Inspection Experience: Demonstrated experience in hosting FDA inspections and managing back-room operations during these evaluations.
- Compliance Auditing: Experience in conducting third-party compliance audits is necessary.
- Electronic Quality Management: Proficiency in electronic quality management systems is a plus.
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Senior Vice President of Quality Assurance
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Pennsylvania, United States Medella Life Full timePosition OverviewThe Vice President of Quality at Medella Life is responsible for overseeing the quality assurance processes across various operational sectors. This role encompasses a wide range of responsibilities aimed at ensuring the highest standards of quality and compliance.Key ResponsibilitiesQuality Assurance Review: Conduct thorough reviews of...
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Senior Vice President of Quality Assurance
2 weeks ago
Pennsylvania, United States Medella Life Full timePosition OverviewThe Vice President of Quality at Medella Life is responsible for ensuring the highest standards of quality across all operations. This role encompasses a wide range of responsibilities, including:Quality Assurance Review: Conduct thorough evaluations of documents and records, ensuring the appropriate disposition of products related to...
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Senior Vice President of Quality Assurance
2 weeks ago
Pennsylvania, United States Medella Life Full timePosition OverviewThe Vice President of Quality at Medella Life is responsible for ensuring the highest standards of quality across all operations. This role encompasses a variety of critical functions aimed at maintaining compliance and enhancing quality management systems.Key ResponsibilitiesQuality Assurance Review: Conduct thorough QA evaluations of...
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Senior Vice President of Quality Assurance
2 weeks ago
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