Associate Director, Project Quality, Vendor Qualification

CSL; Kankakee (IL); On-site; USD 172,000 - 203,000; Full time

Job summary

CSL Behring Behring Kankakee site seeks a Quality Oversight lead to manage external supplier audits and ensure compliance with regulatory requirements across the M7/8 expansion project. You will direct audit programs, facilitate deviation investigations, and oversee supplier quality agreements.

The role requires a strong GxP background, extensive regulatory knowledge, and prior leadership experience in a global pharmaceutical environment.

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, or related science; advanced degree preferred.
• 10+ years’ experience in a GxP environment within the pharmaceutical industry.
• Minimum 3 years’ experience in leading a team.
• Strong regulatory knowledge across FDA, PIC/S, European regulation, TGA, Health Canada, etc.
• Auditing experience (internal and external) within the industry.

Responsibilities

• Implement strategic goals established by functional leadership.
• Lead supplier quality auditing program including auditor qualification and audit determinations.
• Establish risk management tools and supplier/material monitoring concepts.
• Serve as primary site interface for supplier quality matters and project scope.
• Oversee supplier quality agreements and related regulatory communications.
• Support budgetary planning and forecasting for external audits.

Skills

GxP experience

Team leadership

Regulatory knowledge

Auditing

Cross-functional collaboration

Education

Bachelor's degree in relevant science

Job description

Job Purpose:

The growing demand 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 at the CSL Kankakee (KAN) site to accommodate Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8 st CSL Behring Kankakee site.

This role will provide Quality oversight for the external supplier’s/vendor’s activities associated with the

Module 7/8 Site Expansion Project at the CSL Behring Kankakee site.

This position is responsible for ensuring that efficient, compliant, and end-to-end business processes are implemented and maintained for all GxP-related raw material suppliers, service providers, and distributors. The role also leads a small team of auditors responsible for conducting audits of external suppliers and service providers to ensure compliance with applicable regulatory and quality requirements.

Main Responsibilities and Accountabilities:

• Implement strategic goals established by functional leadership.
• Collaborate with External Supply Quality colleagues to manage overall supplier qualification auditing program including establishment of standardized auditor qualification requirements; on-site, remote or paper audit determination.
• Through the identification and utilization of best-in-class practices, establish appropriate risk management tools, supplier and raw material monitoring concepts.
• Serves as primary M7/8 site interface and point of communication of all supplier quality related matters or issues.
• Attends local deviation review meetings and acts as quality liaison between Supplier and Site (M7/8 project scope) to assist deviation investigation processes.
• Participates in change control process as required.
• Performs quality systems audits of approved and/or potential suppliers of raw materials and components, service providers and distributors, for the M7/8 project.
• May also perform M7/8 project site audits, as requested. Representatives and articulate External Supplier Quality policies and procedures during regulatory audits.
• Manages the activities of supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL New (M7/8) Manufacturing location, service providers and suppliers.
• Supports the generation of fiscal year budgetary planning, ongoing forecasting for all external audits.
• In collaboration with Global Sourcing, develops supportive and ongoing positive relationships with the external quality functions within CSL’s Critical Suppliers.

Qualifications:

• Bachelor’s degree in relevant scientific discipline (biology, microbiology,chemistry, etc.); advanced degree preferred

• 10+ years’ experience in a GxP environment in the pharmaceutical industry.
  • Minimum 3 years’ experience in leading a team.
• Thorough understanding of required regulations including but not limited to FDA, PIC/s and European regulation, Therapeutics Goods Administration, Canadian Health Authority, etc.
• Strong industry knowledge (of CSL Behring’s process flow and the plasma business), and auditing knowledge (internal and external) experiences within the industry.
• Must be comfortable working in a global, matrix organization.

Competencies:

• Strong organizational skills. Managing diversity, time management and planning. Cross-cultural sensitivity, perseverance, written and verbal communication.
• Demonstrated experience with directing others and delegation.
• Managerial courage, decision quality, functional and technical skills.
• Proficient in building consensus and escalating issues.
• Excellent communication and organizational skills, as well as negotiation, influencing and collaboration skills. Fluent in English (written and spoken).
• Demonstrated ability to work cross-functionally across internal and external stakeholders.
• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators.

The expected base salary range for this position at hiring is $172,000 - $203,000. 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 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… 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.