Sr. Compliance Auditor
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
This role is responsible for:
- Improve the Inspection Readiness for the facility through self-inspection process and daily activities.
- Communicating compliance improvement recommendations and providing guidance and consultation regarding interpretation of regulatory mandates to the site.
- Preparing for Self-Inspections, Internal Audits, and Regulatory Inspections.
- Responsible for driving site compliance, including communication regarding compliance related issues to management.
- Responsible for preparing the Kankakee site for Inspection Readiness, maintaining the Master Preparation List, and continuously driving SMEs for inspection readiness with respective topics.
- Conduct self-inspections based off of approved Self-Inspection Plan, providing findings to respective departments, and reporting them appropriately for the Quality Management Review meetings.
- Track and update Regulatory commitments and Self-Inspection responses in a timely manner, ensure timelines are met appropriately.
- Remain current with domestic and international regulatory requirements, guidelines, and quality standards.
- Prepare and maintain Quality Agreements for other CSL sites and Affiliates.
- Have sound knowledge of Quality Risk Management guidelines, aligning the site to the global CSL policy.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
- Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties/responsibilities assigned by senior management.
Education and Experience:
- Undergraduate degree in relevant discipline (or equivalent)
- 2 years or more in a similar role
- 2 or more years of significant technical expertise in GMPs
- Knowledge of FDA and European Regulatory guidelines required
- Demonstration competency of verbal and written communication