About this opportunity
BioSpace lists this Associate Director, Project Quality - QC opportunity in kankakee, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Reports To:
Senior Director, Project Quality
Direct Reports:
QC Analysts, QC Sample Management Associate, QCAT Associates
Responsibilities
Provide strategic leadership and governance for all M7/8 QC activities supporting the successful delivery, startup, qualification, validation, and operational readiness of the new IgG manufacturing facility.
Identify, assess, and mitigate project risks impacting QC deliverables, laboratory readiness, testing capacity, method implementation, and qualification timelines, escalating critical issues to senior leadership as appropriate.
Lead QC activities supporting facility design reviews, user requirements, laboratory fit-out, equipment selection, and workflow optimization in consultation with site Operational QC. Develop and execute the overall project strategy, ensuring alignment with project objectives, regulatory expectations, cGMP requirements, site priorities, and CSL quality standards.
Ensure timely readiness of QC activities including utilities and environmental monitoring sampling, testing for project qualification activities, assay tech transfer and validation, equipment purchases and qualification, establishment of new raw materials, and testing support of qualification runs. to support engineering runs, process validation, PPQ activities, and commercial manufacturing.
Develop and execute comprehensive operational readiness plans, including staffing, training, procedures, equipment qualification, and inventory management.
Manage QC activities by project timelines, budgets, resources, and risk mitigation plans to support successful project delivery.
Review and assess existing QC policies and procedures for successful execution of M 7/8. Perform gap assessment and suggest improvements in existing and future procedures and policies.
Establish and maintain a comprehensive QC project roadmap, ensuring milestones, resources, budgets, risks, and deliverables are proactively managed and aligned with overall project timelines
Provide strategic oversight of change control activities related to analytical methods, specifications, testing strategies, laboratory systems, equipment, and quality processes, ensuring timely implementation to meet project objectives.
Build and maintain strong relationships with internal and external stakeholders, including regulatory authorities, equipment suppliers, testing laboratories, consultants, and project partners, as required.
Qualifications
Bachelor’s degree in relevant scientific discipline (biology, microbiology,chemistry, etc.); advanced degree preferred
10+ years' experience in microbiological and biological, chemical or biochemical analytics in a pharmaceutical/medicinal GMP environment
Significant experience in laboratory management, including operations optimization
Strong experience supporting regulatory inspections and customer audits.
Extensive knowledge of analytical instruments and GxP regulations.
Management/demonstrated leadership experience
Experience within a global matrix organization
Six sigma, lean, and/or variability reduction
Ability to work in a fast-paced environment and balance future needs with immediate pressures
The expected base salary range for this position at hiring is $154,000- $193,000. 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.
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 and CSL Plasma at
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
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
#J-18808-Ljbffr
Worksite address
kankakee, IL, 60901, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.