Compliance Engineering Manager

Serves as the Maintenance, Engineering, Facilities, and Utilities (M2U) quality change control and investigation subject matter expert, while providing leadership for the team and oversight for training management. This position is the liaison with site quality to assure alignment with site and global quality policies, change management, and compliance requirements. Assures appropriate documentation is developed to manage change controls initiated by M2U to support project activities (capital and expenses). Required to review and approve change control protocols and related documentation to ensure proper quality attributes are included.
Role that this position reports to: Director of Site, Facilities
Role/that reports to this position: M2U Compliance Engineers, M2U Training Specialist

• Serves as Quality and Compliance subject matter expert for M2U efforts.
• Responsible for assuring that M2U activities are in agreement with Kankakee site, CSL Behring, and

industry standards regarding Quality Assurance, Change Management and Compliance requirements.

• Oversees and manages a team of compliance engineers (change control and investigation owners)

and training specialists.

• Interacts with the Kankakee site quality group to assure project direction, work process changes, and proposed facility process designs agree with quality requirements/ expectations.
• Supports the M2U team in all Change Management activities.
• Directs or participates in risk assessment development, as needed. Manages the change management communication to the other departments/ stakeholders.
• Assures that M2U team members and integrated service providers/ professional contractors are appropriately trained and that documentation and/or Plateau status is available per site

requirements.

• Supports/Participates in all FDA and global regulatory agency meetings and audits to support M2U audit readiness.
• Helps develop strategy, schedule, and metrics to have oversight and management of change controls executed on time with minimal delay and impacts to startup and shutdown plans for manufacturing.
• Collaborate with counterparts at Kankakee and other CSL sites to leverage change control best practices and drive consistency.
• Oversight of experts/trainers and external training providers to design and deliver training programs.
• Other job-related duties as assigned

Education
Bachelor’s degree in Engineering or Science preferred; instead of a Bachelor’s degree
degree, an Associate's degree, or a local equivalent in a related field
Experience
Minimum three years’ experience working in a pharmaceutical or other FDA-regulated industry, applying cGMPs as part of daily activities. Minimum one year of experience supervising two or more staff members. Change control management and regulatory audit experience is a plus.
Competencies
Prior regulatory interaction required. In-depth knowledge of cGMPs. Must demonstrate strong leadership qualities, excellent written and oral communication skills, ability to interpret and apply cGMP and quality principles in daily work, and strong computer/technical skills. Ability to work in a team environment.
*The expected base salary range for this position at hiring is $114,000 - $135,000. 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 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.