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C&Q Lead – E&M Organization
Job Description
Position Summary
The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network. This role ensures compliance with regulatory standards (FDA, EMA, ASTM E2500), drives harmonization of C&Q practices, and provides technical leadership to site engineering teams.
A critical focus of this position is to define, implement, and sustain a strategic shift in the operating model—from a hybrid of self-perform and partner execution to a highly partnered model for C&Q execution across both at-site and above-site projects. The C&Q Lead will champion this transformation, ensuring robust partnership governance, capability building, and seamless integration of external partners into the global C&Q delivery framework. The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.
Key Responsibilities
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.
Job Description
Position Summary
The C&Q Lead is responsible for developing and executing the global commissioning and qualification strategy for Tier 1 capital projects across the biopharmaceutical network. This role ensures compliance with regulatory standards (FDA, EMA, ASTM E2500), drives harmonization of C&Q practices, and provides technical leadership to site engineering teams.
A critical focus of this position is to define, implement, and sustain a strategic shift in the operating model—from a hybrid of self-perform and partner execution to a highly partnered model for C&Q execution across both at-site and above-site projects. The C&Q Lead will champion this transformation, ensuring robust partnership governance, capability building, and seamless integration of external partners into the global C&Q delivery framework. The position also includes establishing strategic partnerships with external C&Q execution vendors and ensuring readiness for regulatory inspections.
Key Responsibilities
- Develop and implement change management strategies to support the adoption and sustainability of the new operating model across the organization.
- Establish and manage robust commercial partnerships with C&Q execution firms, including defining partnership frameworks, performance metrics, and continuous improvement mechanisms.
- Drive the transition from a hybrid self-perform/partner model to a highly partnered C&Q execution model, ensuring external partners are fully integrated into project delivery at both site and global levels.
- Define and implement global C&Q standards aligned with ASTM E2500 and ISPE guidelines.
- Develop governance structures to ensure consistent application across all sites.
- Lead C&Q scope for major capital projects ($50M ) including utilities, facilities, and process equipment.
- Ensure timely delivery of C&Q deliverables (DQ, FAT, SAT, IQ, OQ, PQ) within project timelines and budgets.
- Establish and manage commercial partnerships with C&Q execution firms.
- Negotiate contracts and ensure vendor compliance with global standards.
- Provide expert guidance to site engineering teams on C&Q execution and troubleshooting.
- Build technical capabilities and mentor site CQ SMEs to ensure knowledge retention.
- Ensure C&Q programs meet global regulatory requirements and support audit readiness.
- Lead responses to regulatory inspections related to commissioning and qualification.
- Benchmark industry best practices and implement digital tools for C&Q lifecycle management.
- Drive risk-based approaches and automation in C&Q processes.
- Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Process) or related discipline.
- 12 years in GMP-regulated pharmaceutical manufacturing with strong C&Q expertise.
- Minimum 8 years in leadership roles managing global or multi-site C&Q programs.
- PMP or equivalent; ISPE C&Q training preferred.
- Deep knowledge of ASTM E2500, ISPE Baseline Guides, and risk-based C&Q methodologies.
- Familiarity with validation master plans and computerized systems compliance.
- Experience with biologics, cell & gene therapy, or sterile manufacturing facilities.
- Familiarity with digital C&Q platforms and data analytics tools.
- Global mindset and ability to work in a matrix organization.
- Competency Matrix (CSL Leadership Framework)
- Competency
- Behavioral Indicators
- Proficiency Level - Advanced
- Collaboration
- Builds strong partnerships internally and externally; fosters teamwork and open communication.
- Proficiency Level - Advanced
- Takes ownership of global C&Q performance and compliance outcomes; ensures ethical standards.
- Proficiency Level - Intermediate
- Implements advanced technologies and risk-based approaches; encourages creative problem-solving.
- Proficiency Level - Expert
- Demonstrates transparency, honesty, and ethical leadership in all actions.
- Proficiency Level - Advanced
- Focuses on delivering high-quality outcomes within timelines and budgets; drives continuous improvement.
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.