Senior Manager, Project Quality, Validation

Job Purpose:

The growing demand for an expanding production line requires an expansion of CSL's manufacturing capacity. To support this growth, immunoglobulin (Ig) production activities—from plasma thawing through sterile filling—will be incorporated into the new Building under construction at the CSL Kankakee (KAN) site to accommodate Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8.

This role will provide Quality oversight for the Commissioning, Qualification and Validation (CQV) activities associated with the M 7/8 Site Expansion Project at the CSL Behring Kankakee site for systems, utilities, computerized systems and equipment.

The position partners closely with colleagues in Project Quality, Site Quality, and Process Engineering to ensure consistent application of quality principles, systems, and documentation standards. A key responsibility is to drive a standardized approach across projects, ensuring alignment in processes, documentation, and execution.

The successful candidate will be expected to build and maintain strong collaborative relationships across all levels of the organization and with external contractors. The role requires exceptional interpersonal skills, cross-functional collaboration, and the ability to influence and work effectively within a complex project environment.

Responsibilities & Accountabilities:

• Ensure GMP-compliant planning and implementation of validation related project tasks. Participate in project teams to provide review and approval of project Validation documentation according to applicable approval matrix or procedures.
• Maintain quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance.
• Review and approve standards and procedures governing quality systems and processes.  Supports document management, change control, deviation handling, relevant to CQV.
• Provide quality oversight and approval of change controls, deviations and investigations, CAPAs, and Periodic Review assessments involving GxP Computerized Systems.
• Provide CQV Quality Oversight of the GMP-compliant realization of CAPEX projects.
• Provide technical advice on CQV issues/concepts.
• Actively participate in problem solving and identifying opportunities for improvement to optimize validation activities.
• Reviews and approves equipment, computerized systems, utilities, facilities documentation for qualification and validation activities (i.e. Protocols, Reports, Revalidations etc.).
• Reviews and approves validation governance documentation including procedures, templates, project plans, risk assessments and validation master plan for M7/8 and support with the delivery of global approaches.
• Actively maintain current knowledge relating to equipment qualification and validation activities. Information will be gained through regulatory, industry and company sources.
• Promote the education and implementation of the relevant regulatory requirements including the FDA, PIC/S, EMA and other industry regulations and guidelines (PDA, ICH etc.).
• Provide leadership, guidance, and direction to direct reports.

Reporting Relationship:

Reports To: Senior Director, Project Quality

Direct Reports: Sr. QA Specialists (including CW professionals)

Education:

• Degree in relevant scientific discipline, or related (Pharmacy, Chemistry, Biology, Biochemistry)

Experience:

• 7 plus years' experience in quality/GMP in the pharmaceutical/biotech industry including 1 – 3 years’ leadership/team management experience
• Demonstrated experience in quality assurance and regulatory compliance with FDA and other regulatory agency guidelines and in manufacturing of biologics
• Experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms
• Strong quality process knowledge
• Experience in working in a matrix/global environment
• Engineering experience desirable

Competencies:

• Effective and risk-based decision-making ability in a quality environment
• Proven expertise in GMP, FDA, EU and other relevant GxP regulations
• Ability to influence others through clear, concise and effective communication
• Good organizational and interpersonal skills
• Collaborate effectively with internal and external colleagues and stakeholders
• Experience in project-oriented working methods and business /QA systems
  

The expected base salary range for this position at hiring is $119,000 - $153,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.