Top 2610 Manager, project quality validation Jobs in Elwood, Il

Manager, Project Quality Validation
CSL Behring —Kankakee, IL
- $91,000 - $120,000 a year
- Full-time
- 5 years
- English
- Office
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Top Bun Transport —Bolingbrook, IL
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- Paid holidays
- Disability insurance
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Executive Assistant Strategic Project Manager
UChicago Medicine AdventHealth Bolingbrook —Bolingbrook, IL
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- Microsoft Outlook
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Mondi —Romeoville, IL
- $120,000 - $125,000 a year
- Management
- Mid-level
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Continuous Improvement Manager
Provisur Technologies —Mokena, IL
- $110,000 - $130,000 a year
- Full-time
- Hybrid work
- Inventory management
- Mid-level
- 3 years
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- Health insurance
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Quality Manager
IMTT —Lemont, IL
- Full-time
- Microsoft Excel
- English
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The Scotts Miracle-Gro Company —Channahon, IL
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- 5 years
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Precision Property Pros —Lockport, IL
- Part-time
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- High school diploma or GED
- Driver's License
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Rehab Without Walls Neuro Rehabilitation —Downers Grove, IL
- $72,800 - $85,280 a year
- Full-time
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Housing Choice Voucher Program Manager
Housing Authority of Joliet —Joliet, IL
- Full-time
- Microsoft Excel
- Mid-level
- Supervising experience
- Health insurance
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Factory Logistics Manager
G&W Electric Co —Bolingbrook, IL
- $96,555 - $128,577 a year
- Full-time
- Organizational skills
- Senior level
- Communication skills
- Profit sharing
- Disability insurance
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Automotive Parts Manager
Rod Baker Ford —Plainfield, IL
- $135,000 - $175,000 a year
- Full-time
- Background check
- Clean driving record
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Customer Relations Project Manager
Veritiv —Lockport, IL
- $53,100 - $72,800 a year
- Full-time
- Hybrid work
- Oracle
- Mid-level
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Workforce Project Manager
Lewis University —Romeoville, IL
- $58,000 a year
- Full-time
- Spanish
- Microsoft Outlook
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Customer Account Manager (CAM)
RJW Logistics Group —Romeoville, IL
- $60,000 - $65,000 a year
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Health savings account
- Paid holidays
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Fleet Manager
DAVID MICHAEL PRODUCTIONS INC —Woodridge, IL
- $85,000 a year
- Full-time
- Pass drug screening
- Mid-level
- Health insurance
- Dental insurance
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Operations Manager
Warehouse on Wheels —Crest Hill, IL
- $80,000 - $90,000 a year
- Full-time
- Management
- CDL A
- Mid-level
- Health insurance
- Paid time off
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Operations Manager, Managed Care
Silver Cross Hospital —New Lenox, IL
- $48.42 - $60.52 an hour
- Full-time
- Bachelor's degree
- Business Administration
- Senior level
- Wellness program
- Health insurance
Communications Manager
Catholic Charities, Diocese of Joliet —Crest Hill, IL
- $72,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Public speaking
- Disability insurance
- Health insurance
Quick Apply
7d
Operations Manager I - 2nd Shift
Neovia —Joliet, IL
- $88,082 - $132,123 a year
- Word processing
- Computer literacy
- Mid-level
Quick Apply

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manager, project quality validation jobs near elwood, il

Manager, Project Quality Validation

CSL Behring -
Kankakee, IL

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Job Details

Full-time
$91,000 - $120,000 a year

Qualifications

Biotechnology
Drug regulation
Manufacturing facility experience
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
QA/QC
Regulatory/legal compliance standards in production
Cleanroom experience
Biomedical regulatory compliance
Commissioning phase involvement
Stakeholder relationship building
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Entity: CSL Behring

Job Category: Quality

Job Family: Quality Assurance

Job Type: Full Time

Location: Kankakee, Illinois, United States

Employer Reference: R-285852

Job Description

Job Purpose:

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.

Responsibilities & Accountabilities:

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.)

Education:

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

Experience:

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
Engineering experience desirable

Competencies:

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)

Working Conditions:

As defined in an office position. Primarily sitting and working on a computer.

Travel Requirements:

Potential travel required

The expected base salary range for this position at hiring is $91,000 - $120,000. 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

#GTA

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.

Apply Now

Refine Your Search

manager, project quality validation jobs in elwood, il

Manager, Project Quality Validation

Transport Manager

Executive Assistant Strategic Project Manager

Quality Manager

Continuous Improvement Manager

Quality Manager

Plant Manager

Office Manager

Case Manager

Housing Choice Voucher Program Manager

Factory Logistics Manager

Automotive Parts Manager

Customer Relations Project Manager

Workforce Project Manager

Customer Account Manager (CAM)

Fleet Manager

Operations Manager

Operations Manager, Managed Care

Communications Manager

Operations Manager I - 2nd Shift

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Job Description

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Our Benefits

You Belong at CSL

Equal Opportunity Employer

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