Job Description:
This position will be responsible for supporting and fostering Quality Assurance Compliance related to supplier quality. The position will also be responsible for overseeing external suppliers throughout the product life cycle this includes evaluating and qualifying suppliers, monitoring their performance auditing their quality management systems and addressing any quality and regulatory issues that arise the rule aims to ensure compliance with applicable regulations and quality standards while driving continuous improvement in supplier quality management. This position will also be responsible for quality compliance and assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations.
Responsibilities:
- Manage the Supplier Quality areas with contract manufacturing organizations (CMOs) for assigned projects.
- Collaborate with team members to improve supplier qualification procedures and documents to improve supplier oversight
- Assist on continuous improvement projects for either suppliers or internal cross functional teams
- Adhere to good manufacturing practices (GMPs) based on quality management system requirements for products, managing applicable internal corrective actions to assure effectiveness and avoid repeat issues
- Responsible managing the external suppliers throughout the product life cycle, this includes evaluating and qualifying suppliers, monitoring their performance, their quality management systems, and addressing any quality and regulatory issues that may arise the role aims to ensure compliance with applicable regulations and quality standards while driving continuous improvement in supplier quality management
- Author SOPs as needed
- Identify and lead assigned continuous improvement projects of either suppliers or internal cross functional teams
- This position manages the audit program, ensuring accurate and complete audit documentation and quality management system implementation and enhancements
- This position will be accountable for the supplier quality management program including but not limited to the qualification of external manufacturers audits and quality agreements
- Monitor the compliance status and performance of the external network of suppliers perform the product and supply risk assessments ensure the external networks risk profile is current.
- Develop, maintain, and report quality metrics to monitor supplier Quality Assurance and other areas related to Quality Systems as required.
- Perform other duties as assigned.
Qualifications:
- Minimum bachelor’s degree in Life Sciences or related field.
- At least 5 years of experience in the pharmaceutical industry.
- Thorough understanding of cGMPs
- Veeva is a strong plus
- Audit background is also a plus
PA: Supplier Quality Manager (237051)
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