Manager, QC (Compliance, Stability & Logistics)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Apr 29, 2021
Ref
R-133635
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:

Provide leadership to the Quality Control teams responsible for QC Compliance, Stability, GLIMs, Logistics and Sample management. Individual will recruit and develop resources to ensure full cGMP compliance. The role includes review and preparation of regulatory filing sections, review and oversight of QC investigations, change controls, and relevant document revisions. This individual is responsible for the team's timely completion of activities as well as budget oversight. This individual will provide strategic and technical knowledge to ensure all relevant cGMP requirements are met and the team is supported for development and growth.

Major Accountabilities:
  • Management of employees
  • Ensure adequate resources are available to complete key tasks on time and in full
  • Provide coaching and development of team to ensure attrition rates remain low
  • Ensure team lead coordinate's time, resources, and schedules
  • Ensure training of staff is appropriate and completed to yield a high level of competence
  • Set, monitor and evaluate goals and performance
  • Manage KPI's and metrics
  • Ensure on-time completion of work including timely closure of investigations
  • Maintain and improve cGMP compliance
  • Maintain compliance with legal regulations on occupational safety and health
  • Implement and maintain laboratory policies and procedures as necessary
  • Drive lean laboratory operation, 5S laboratory layout, preventive action & continuous improvement programs to reduce operating costs


Minimum Qualifications:
  • BS degree in Microbiology, Virology, Chemistry, Biochemistry, Biology or other related scientific field.
  • Minimum of 5 years directly relevant industry experience required, 8+ years preferred.
  • Prior supervisor/management experience required.
  • Advanced knowledge of stability programs for pharmaceuticals or vaccines preferred.
  • Advanced knowledge of Quality Systems preferred.
  • Statistical knowledge, Investigational technical writing skills and LIMS experience a plus.
  • Advanced knowledge of GMPs, safety regulations and data integrity.