Manager, Project Quality Validation
About The Position
The growing demand for Privigen and Hizentra 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 45 at the CSL Kankakee (KAN) site to accommodate ZAPP Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8 at the CSL Behring Kankakee site. This role will provide Quality oversight for the Commissioning and Qualification activities (C & Q). Partnering closely with colleagues in Project Quality, KAN Site Quality, Global Engineering, and TechOps across multiple manufacturing sites to ensure consistent application of quality principles, systems, and documentation standards. The incumbent will focus on driving a standardized approach across projects, ensuring alignment in processes, documentation, and execution. Responsible for building and maintaining strong collaborative relationships across all levels of the organization and with external contractors.
Requirements
- Degree in relevant scientific discipline, or related (Pharmacy, Chemistry, Biology, Biochemistry)
- 5 years' experience in quality/GMP in the pharmaceutical/biotech industry
- Demonstrates experience in quality assurance and regulatory compliance with FDA, TGA, EU, 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
- Efficient and risk-based decision-making ability in a quality environment
- Knowledge of 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
- Fluent English skills (spoken and written)
Nice To Haves
- Engineering experience desirable
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. Supports document management, change control, deviation handling, relevant to C&Q.
- Support all regulatory inspections, self-inspections, internal audits and customer audits
- Collaborate cross-functionally and communicate best practices
- Provide Quality Oversight of the GMP-compliant realization of CAPEX and OPEX projects
- Provide technical advice on qualification and validation issues/concepts.
- Actively participate in problem solving and identifying opportunities for improvement to optimize validation activities.
- Reviews and approves equipment, 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 site processes 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.)
Benefits
- In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
