Manager, Supply Chain Quality - Pharma Distribution
This position is responsible for working with Logistics, Commercial and Distribution Partners to ensure high standards of compliance for transportation, storage and commercial distribution of finished product including Quality support to the non-manufacturing site Quality Organizations. Additionally, the role will support the audit activities for Seqirus by acting as a subject matter expert when required. Specifically, the role will have a primary focus on America regions and will have QA oversight of the primary distribution center in the US.
- Provide QA leadership to Seqirus team and QA oversight of operations in the distribution center location in the US ensuring GxP systems are in place and effective.
- Collaborate with Commercial Operations, Sourcing, Supply Chain and Supplier Management leaders to ensure compliant onboarding and management of MAHs, distribution partners and storage/transport companies within the America regions. Input to and approval of Quality Agreements with external distribution companies.
- Provide QA Oversight of the Quality Management System for Commercial Affiliates and Distribution Business Partners.
- Represent Seqirus Quality in cross-business teams to develop successful partnerships for consistent GxP-compliant planning and distribution of products
- Manage Supply Chain Quality performance metrics, driving to optimize performance. Resolve Quality issues and optimize outcomes, facilitating linkage with internal Quality resources, as appropriate
- Participate in audits to ensure compliant distribution channels and other supplies/services. Act as SME for compliance audits of external distributors, in-country transport and warehouse providers where required.
- Represent Supply Chain Quality in external audits by regulators/customers and ensure SCQ-related observations are addressed appropriately and timely. Support remedial actions (e.g. CAPA) with operational areas of the business.
- Review and approval of transportation data and disposition of vaccine products for in country distribution. Manage transport related deviations ensuring root cause analysis is performed and appropriate remediation actions are defined and implemented.
- Bachelor’s degree in science, business, economics, engineering, supply management, or related field preferred
- 2-3 years in a GxP environment with experience in Quality Assurance and temperature-controlled shipments or storage of products
- The role holder needs to be able to work with limited supervision and with multinational teams speaking different languages. Ability to influence at different levels within and external to the company is required.
- A good understanding of Good Distribution Practice is essential.
- The requirements for the design and validation of robust temperature-controlled shipping solutions together with the ability to assess deviations and make compliant recommendations for product disposition is essential for the role.
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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