Sr. Manager, Supply Chain Quality

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 14, 2020
Ref
R-120194
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary:

This position is responsible for managing 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 (Commercial affiliates and Maidenhead supply Hubs).

Major Accountabilities:
  • Collaborates with Commercial Operations, Customer Services, Sourcing and Supply Chain/Logistics leaders to ensure integration of GxP-related requirements into the distribution, storage/transport and/or supply of materials and equipment suitable for pharmaceutical use globally. Provide oversight of In-Country QA organizations. Responsible for ensuring a compliant end-to-end business process for Logistics Service Providers, Distribution Business Partners, and Customer Services.
  • Leads QA oversight of the Distribution Business Partners globally, driving GxP compliance. Liaise with the Seqirus commercial team and the third party logistics company management team to deliver compliant product storage and distribution for the all markets.
  • Represents Seqirus Quality in cross-business teams to develop successful partnerships for consistent GxP-compliant procurement, planning and distribution of products.
  • Manages Supply Chain Quality performance metrics, driving to optimize performance. Participate in resolving Quality issues and optimize outcomes, facilitating linkage with internal Quality resources, as appropriate
  • Participate in and lead audits, when required, to ensure compliant distribution channels and sourcing of raw materials and other supplies/services. Act as SME for compliance audits of external distributors, in-country transport and warehouse providers. Support qualification and management of suppliers and service providers to ensure they consistently meet GxP-requirements of the company
  • Represent Supply Chain Quality in external audits by regulators/customers and ensure SCQA 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.


Minimum Requirements:
  • B.S. Degree and minimum 5+ years experience in Quality or Supply Chain or equivalent without degree
  • 3+ years in a GxP environment and experience in pharmaceutical cold chain warehousing and distribution.
  • Ability to work with limited supervision in a global team
  • S trong understanding of the requirements for the design and validation of robust temperature controlled shipping solutions
  • A bility to assess deviations and make compliant recommendations for product disposition is essential for the role.
  • Knowledge of GDP and regulatory agency requirements and expectations.
  • Knowledge of continuous improvement techniques and root cause analysis.
  • Leadership skills in supervision of teams.
  • Ability to influence and motivate others while maintaining a cohesive team environment.