Manager, QAO Operations

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Jul 18, 2021
Ref
R-135955
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time

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

The QA Manager provides oversite to to a team within the value stream to ensure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.  This role is a hands-on, on the manufacturing floor manager role supporting a 24-7 manufacturing site.

Responsibilities:

Directs and manages quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.

  • Responsible for product quality and Compliance for Value Stream. Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
  • Drive continuous quality improvement projects and global harmonization initiatives
  • Identifies and determines quality improvement
  • Maintain clear communication paths with stakeholders

Manage Quality Staff within the  department to assure knowledge and execution of site Quality System and procedures. Ensure the quality staff remains current on training for their role.

Provide immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.

On-call for immediate inspections, investigations, and review of possible GMP related issues, and ability to provide quality assessment of potential deviations.

Assure proper use of change management associated with validated processes. Responsible for quality approval of Shutdown PRs, ensuring all changes performed are classified appropriately and all work is defined within Value Stream. Responsible for approval and release of production area to return to operations.

  • Responsible for area audits appropriate to Value Stream, and collaborating with manufacturing personnel to resolve issues real-time, driving continuous improvement on production floor to ensure compliance to cGMPs. Ensures timely resolution of quality events on the manufacturing floor.

Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.

Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.

Responsible for preparing deviation summaries for Annual Product Quality Reports (APQR).

Participate and support regulatory audits.

Provide quality oversite  of validation protocols/reports.

Performs other duties as assigned based on business needs

Education and Experience:

B.A. or B.S. degree, preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science

  • Six or more years’ experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities.
  • Specific experience in the process of change control and deviations is preferred.
  • Prior direct supervisory experience is preferred, must have a minimum of 3 years coaching and mentoring others
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Experience with Customer interface and meeting customer expectations.
  • Demonstrate team building and problem-solving skills
  • Ability to effectively prioritize and escalate issues
  • Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)