Senior Manager, Project Quality, Validation

CSL Plasma; Kankakee (IL); On-site; USD 119,000 - 153,000; Full time

Job summary

CSL Plasma in Kankakee, IL seeks a Quality lead to oversee CQV activities for the M7/8 Ig expansion, ensuring GMP-compliant validation of systems, utilities, and equipment. The role partners with Project Quality, Site Quality, and Process Engineering to standardize processes and documentation.

The candidate will drive cross-functional collaboration, manage change controls, deviations, and investigations, and provide leadership across the project team in a complex environment.

Qualifications

• 7+ years in quality/GMP in pharma/biotech with some leadership experience.
• Demonstrated FDA and regulatory compliance experience.
• Experience overseeing GMP commissioning/qualification of facilities.

Responsibilities

• Provide CQV quality oversight for site expansion validation activities.
• Review and approve CQV documentation and governance artifacts.
• Lead change controls, deviations, CAPAs and regulatory documents.

Skills

Quality oversight

GMP compliance

Regulatory compliance

Cross-functional collaboration

Project quality

Documentation governance

Problem solving

Education

Degree in relevant scientific discipline

Tools

GxP Computerized Systems

SOPs development

Job description

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.

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

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.