Top 723 CSL Behring Jobs

Global Sterility Assurance Systems & Standards Lead
CSL Behring —Bradley, IL
- Full-time
- 8 years
- Bachelor's degree
- Experience equivalent to degree accepted
Manager Coagulation Products, South Region TN
CSL Behring —Hartford, CT
- Weekends as needed
- 5 years
- Bachelor's degree
- Travel
Area Manager Specialty. Southeast Region
CSL Behring —Hartford, CT
- Weekends as needed
- 5 years
- Bachelor's degree
- Travel
- Paid holidays
- Disability insurance
Associate Director, Incident Response and Forensics
CSL Behring —King of Prussia, PA
- Full-time
- 8 years
- Analysis skills
- Conflict management
Area Manager, Specialty, Northeast Long Island Area
CSL Behring —Hartford, CT
- Weekends as needed
- 5 years
- Bachelor's degree
- Travel
Area Sale Manager, Specialty Birmingham, AL
CSL Behring —Hartford, CT
- Weekends as needed
- 5 years
- Bachelor's degree
- Travel
Area Sales Manager, Nephrology Houston
CSL Vifor —Almont, CO
- Full-time
- Private practice
- Hospital
- 5 years
Associate Director, Clinical Assay Strategy, Flu
CSL Seqirus —Waltham, MA
- $179,000 - $212,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Doctor of Philosophy
Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines
CSL Seqirus —Holly Springs, NC
- $154,000 - $182,000 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Bachelor's degree
Regional Sales Manager - Great Lakes
CSL Seqirus —Detroit, MI
- Full-time
- 3 years
- Bachelor's degree
- Senior level
Director, Portfolio Development Process & Standards Lead
CSL Behring —King of Prussia, PA
- $230,000 - $270,000 a year
- Full-time
- Hybrid work
- Nursing
- Office
- 3 years
Area Sales Manager - Boston North
CSL Behring —Boston, MA
- Full-time
- Hospital
- Clinic
- Bachelor's degree
Auditor - GVP
CSL Behring —King of Prussia, PA
- Full-time
- Up to 50% travel
- Bachelor of Science
- Mid-level
12d
GRA CMC Specialist
CSL Behring —King of Prussia, PA
- Full-time
- 5 years
- Analysis skills
- Bachelor's degree
Area Sales Manager, Nephrology Nashville, TN
CSL Vifor —Almont, CO
- Full-time
- Private practice
- Hospital
- 5 years
Sr Manager, Continuous Improvement Albumin
CSL Behring —Kankakee, IL
- $138,000 - $163,000 a year
- Full-time
- 7 years
- Master's degree
- Mentoring
Director, Project Management Search & Evaluation
CSL Behring —King of Prussia, PA
- $234,000 - $260,000 a year
- Full-time
- Hybrid work
- Office
- Doctor of Philosophy
- SharePoint
CQA Vendor Oversight and Quality Assurance Lead (US)
CSL Behring —King of Prussia, PA
- Full-time
- Up to 50% travel
- 3 years
- Analysis skills
Area Sales Manager Seattle, WA
CSL Behring —Seattle, WA
- Full-time
- Hospital
- Clinic
- Bachelor's degree
Auditor - GCP
CSL Behring —King of Prussia, PA
- Full-time
- Up to 50% travel
- Bachelor of Science
- Mid-level

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Global Sterility Assurance Systems & Standards Lead

CSL Behring -
Bradley, IL

Apply Now

Job Details

Full-time

Qualifications

Regulatory inspections
Microbiology
GxP
Microbiology
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Quality inspection
Regulatory readiness in healthcare
Regulatory/legal compliance standards in production
Regulatory submissions
Quality control experience within pharmaceutical industry
Legal compliance
Pharmaceutical manufacturing facility experience

Full Job Description

Global Sterility Assurance Systems & Standards Lead

Reporting to the Head of Global Sterility Assurance, this strategic position sits in the Global Quality Operations organisation. Ensuring the quality, safety and reliable supply of our products’ pipeline is critical. This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.

By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.

Responsibilities:

Provide strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance

Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
Provide expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
Proactively work with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
Provide CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…)
Provide strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
Develop and lead Sterility Assurance Roadmaps for compliance and performance
Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence

Qualifications:

Bachelor’s degree in microbiology or biology or life sciences or equivalent relevant field
8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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

CSL Behring jobs

Global Sterility Assurance Systems & Standards Lead

Manager Coagulation Products, South Region TN

Area Manager Specialty. Southeast Region

Associate Director, Incident Response and Forensics

Area Manager, Specialty, Northeast Long Island Area

Area Sale Manager, Specialty Birmingham, AL

Area Sales Manager, Nephrology Houston

Associate Director, Clinical Assay Strategy, Flu

Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines

Regional Sales Manager - Great Lakes

Director, Portfolio Development Process & Standards Lead

Area Sales Manager - Boston North

Auditor - GVP

GRA CMC Specialist

Area Sales Manager, Nephrology Nashville, TN

Sr Manager, Continuous Improvement Albumin

Director, Project Management Search & Evaluation

CQA Vendor Oversight and Quality Assurance Lead (US)

Area Sales Manager Seattle, WA

Auditor - GCP

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