Specialist/Sr. Specialist, QA Supplier Management

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 31, 2021
Ref
R-148118
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Summary:

  • Reporting to the Senior Manager, Audit/Inspections and Supplier Management or Manager of Supplier Management (If Applicable), this role is responsible for all aspects of Supplier Management activities.
  • Under Minimal supervision, responsible to ensure Third Parties (Suppliers, Service Providers, Third Party Laboratories, 3PLs, Distribution Business Partners, etc.) conduct operations in compliance with regulatory and Seqirus requirements by providing quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement.
  • This individual will be responsible to ensure the Supplier Management program (Quality Agreements, Performance Reviews, Change Notifications, Third Party Complaints, Enrolments, etc.) is executed successfully including working closely to resolve deviations related to supplier material issues. 
  • This individual is also responsible to support the harmonization efforts, maintain and enforce global supplier management strategies and ensure SOPs are consistent across manufacturing sites.

Major Responsibilities:

Provides support for the establishment and management of the Quality Supplier Management Program

  • Maintain and execute the company’s Quality Supplier Management Program
  • Assist in the development a global Approved Suppliers List in collaboration with other sites
  • Assist in establishing the strategy, standards, global processes and procedures for supplier and material introduction/enrolment and on-going monitoring
  • Manage the establishment and maintenance of Quality Agreements with Third Parties
  • Assist 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
  • Manage implementation of supplier change notifications
  • Provide 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

Maintain processes, procedures and SOPs for Supplier Management

  • Manage the development of quality policies, procedures and standards governing the global Supplier Management program
  • Maintain and update processes, procedures, and SOPs based on continuous improvement for Supplier management
  • Partner with stakeholders to develop and communicate innovative, compliant solutions using a risk-based approach for managing suppliers
  • Support the global model for Supplier Management

Maintain and share knowledge of Regulations and Requirements

  • Stay current and up to date with any regulations and requirements related to supplier management as well as industry/regulatory trends in this area
  • Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally

Participates and Supports Regulatory inspections at Seqirus sites

  • Provide support and subject matter expertise to sites in preparation and execution of regulatory inspections
  • Participate in inspections to understand root causes behind quality issues
  • Support strategic resolutions to quality issues identified during regulatory or internal inspections.

Support the Audit and Inspection Team

  • Provide support and expertise during self-inspections and external Third-Party audits

Minimum Requirements:
  • Bachelor's degree in science or engineering discipline required. Advanced degree preferred.
  • Minimum 3 years of experience required in manufacturing, quality experience in regulated industry, biotech/pharmaceutical industries preferred. 5 years preferred.
  • Demonstrated leadership and knowledge of Quality Systems and Supplier Management required
  • Experience managing a cross-functional team
  • Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations required
  • Demonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teams
  • In depth knowledge of the regulatory environment for the manufacture of drugs
  • Must possess thorough knowledge of global cGMP regulations and ISO standards
  • Demonstrated ability to understand data sets and drive to data-based decisions

About Us

Our Benefits

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.

About 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.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

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