Specialist/Sr. Specialist (Supplier Management)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 07, 2021
Ref
R-126907
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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 Purpose:

Responsible to ensure Third Parties (Suppliers, Service Providers, Third Party Laboratories, 3PLs, Distribution Business Partners, etc.) conduct operations in compliance with regulatory and Seqirus. Provides quality oversight and guidance to identify quality risks, assess severity, and facilitates appropriate mitigations to ensure compliance and continuous improvement.

Responsible to ensure the Supplier Management program (Quality Agreements, Performance Reviews, Change Notifications, Third Party Complaints, Enrolments, etc.) is executed successfully. Works closely to resolve deviations related to supplier material issues.

Supports the harmonization efforts, maintains and enforces global supplier management strategies, and ensures SOPs are consistent across manufacturing sites.

*Level will be determined based on years of experience.

Major Attributes:
  • Maintains and executes the company's Quality Supplier Management Program.
  • Assists in the development a global Approved Suppliers List in collaboration with other sites.
  • Assists in establishing the strategy, standards, global processes and procedures for supplier and material introduction/enrolment and on-going monitoring.
  • Manages the establishment and maintenance of Quality Agreements with Third Parties.
  • Assists in managing the development and reporting on supplier quality Key Performance Indicators (KPIs) driving to optimize performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or system.
  • Manages the implementation of supplier change notifications.
  • Provides support and expertise to the site for any quality issues encountered from suppliers (third-party complaints) and to work with the supplier directly to obtain investigation responses and corrective action plans to address quality failures and issues.
  • Maintains processes, procedures and SOPs for Supplier Management.
  • Manages the development of quality policies, procedures and standards governing the global Supplier Management program.
  • Maintains and update processes, procedures, and SOPs based on continuous improvement for Supplier management.
  • Partners with stakeholders to develop and communicate innovative, compliant solutions using a risk-based approach for managing suppliers.
  • Supports the global model for Supplier Management .
  • Maintains and share knowledge of Regulations and Requirements.
  • Stays current and up to date with any regulations and requirements related to supplier management as well as industry/regulatory trends in this area.
  • Identifies and/or creates new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally.


Minimum Qualifications:
  • Bachelor's degree required. Science or engineering discipline preferred.
  • Minimum of 5 years of relevant experience within the pharmaceutical industry, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred. 8 years preferred.
  • Strong interpersonal, communication, and collaboration skills required.
  • Demonstrated knowledge of Quality Systems and Supplier Management.
  • Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations.
  • Demonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teams.
  • Knowledge of the regulatory environment for the manufacture of drugs.
  • Knowledge of global cGMP regulations and ISO standards.
  • Demonstrated ability to understand data sets and drive to data-based decisions.