Manager, Project Quality Validation

Support the expansion of CSL's manufacturing capacity by providing Quality oversight for the Commissioning and Qualification (C & Q) activities of the new immunoglobulin (Ig) production facility (Building 45 / Module 7/8) at the CSL Behring Kankakee site. Partner with Project Quality, KAN Site Quality, Global Engineering, and TechOps to ensure consistent application of quality principles, systems, and documentation standards across multiple manufacturing sites.

Responsibilities

• Ensure GMP-compliant planning and implementation of validation-related project tasks.
• 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.
• Support document management, change control, and deviation handling relevant to C&Q.
• Support regulatory inspections, self-inspections, internal audits, and customer audits.
• Collaborate cross-functionally and communicate best practices.
• Provide Quality oversight for GMP-compliant realization of CAPEX and OPEX projects.
• Provide technical advice on qualification and validation issues/concepts.
• Actively participate in problem-solving and identify opportunities for improvement to optimize validation activities.
• Review and approve equipment, utilities, and facilities documentation for qualification and validation activities (e.g., protocols, reports, revalidations).
• Review and approve validation governance documentation, including procedures, templates, project plans, risk assessments, and validation master plans.
• Maintain current knowledge of equipment qualification and validation activities through regulatory, industry, and company sources.
• Promote education and implementation of relevant regulatory requirements, including FDA, PIC/S, EMA, and other industry guidelines (PDA, ICH).

Requirements

• Degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biochemistry).
• 5+ years of experience in quality/GMP within the pharmaceutical/biotech industry.
• Experience in quality assurance and regulatory compliance with FDA, TGA, EU, and other regulatory agency guidelines, particularly in biologics manufacturing.
• Experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms.
• Strong quality process knowledge and experience working in a matrix/global environment.
• Engineering experience is desirable.

Skills

• Efficient and risk-based decision-making in a quality environment.
• Knowledge of GMP, FDA, EU, and other relevant GxP regulations.
• Ability to influence others through clear, concise, and effective communication.
• Strong organizational and interpersonal skills.
• Ability to collaborate effectively with internal and external colleagues and stakeholders.
• Experience in project-oriented working methods.
• Fluent English skills (spoken and written).

Working Conditions

Primarily office-based, involving sitting and computer work. Potential travel may be required.

Pay

Expected base salary range: $91,000 – $120,000. Individual base salary is determined by qualifications, skill level, experience, competencies, and other relevant factors. Total compensation may also include incentive compensation and equity.