Manager, Front Line Quality Assurance (Bulk Manufacturing / QC / Warehouse)

CSL Behring
Holly Springs, North Carolina
Sep 09, 2020
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 Purpose:

Manager and department owner for the quality oversight of Bulk Manufacturing, QC Laboratories, and Warehouse at the US Holly Springs site. This role provides technical support and quality oversight for cGMP compliance related matters including assurance that all aspects comply with cGMPs, regulatory requirements, the Quality Manual, and site SOPs. The areas of direct quality support include presence on the floor (production/lab/warehouse), executed document review (logbooks and batch records), document revision management, change control, deviation, and CAPA. Additionally, this role manages the activities, deliverables, and development of their direct reports.

Major Responsibilities:
  • Builds and manages a collaborative, high performing team of Quality Professionals by clearly defining expectations, holding individuals accountable, managing prioritization/workload allocation, performance management, recognizing accomplishments, and ensuring professional development
  • Ensure proper staffing, training, and development of team to support the needs of the operational facility in their area of quality oversight
  • Develop, measure, and respond to team KPIs and quality system metrics along with the other members of the FLQA management team
  • Ensures collaboration of the FLQA team with other shifts, functions, and departments
  • Drives adherence to and continuous improvement of the quality systems within their areas of oversight
  • Leads improvement projects of medium to large scope and may provide quality support to site capital projects within their areas of oversight
  • Act as quality decision maker (on the floor as applicable) during issue resolution for major quality concerns
  • Ensure all major and critical quality issues in their areas are appropriately investigated and CAPAs created to prevent recurrence. Initiates reporting to CBER for quality issues impacting distributed product.
  • Ensures inspection readiness in their areas via routine quality walkthroughs, monitoring quality system adherence, and direct involvement in Site Self Inspections
  • Acquires, maintains, and applies knowledge of current local and international regulatory requirements and trends concerning their areas of quality oversight
  • May support and/or coordinate the allocation of work to other members of the FLQA department who are staffed in off shift roles

As needed to support team workload, may perform the following FLQA core tasks:
  • Perform activities related to approving Deviations, CAPAs, and Change Controls utilizing the related electronic management systems Trackwise, SAP, LIMS, etc.
  • Perform real time batch record/logbook review concurrent with manufacturing operations on the manufacturing floor
  • Provide quality oversight of site critical alarm reports and corrective maintenance program
  • Support the development and revision of SOPs and batch records

Minimum Requirements:

  • Bachelor's degree in related engineering or scientific field
  • 5+ years' relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing
  • Demonstrated knowledge of cGMPs, FDA requirements, and Quality Systems

Strongly Preferred:
  • 2+ years of demonstrated leadership in a supervisory role or leadership in an area of technical subject matter expertise
  • 2+ years Quality Assurance experience in a FDA regulated environment
  • Previous experience in ownership and/or approval of GMP deviations, CAPAs, and change controls
  • Previous experience directly operating or supporting a Bulk/API process
  • Previous experience directly operating or supporting a QC Laboratory
  • Strong technical understanding of the production processes used in the pharmaceutical/biotechnology industry