Lead internal audits of Fresenius Kabi facilities based on the FDA’s System Based Inspection Policy and GMP and other GxP. Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings, including compliance risk. Lead / participate in Global / Divisional internal audits of Fresenius Kabi facilities as required. Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings to Fresenius Kabi management. Review and evaluate internal audit response against Fresenius Kabi’s policies and procedures requirements, current industry standards, regulations, and guidelines to assure compliance. Drive closure of corrective and preventive actions to ensure implementation, compliance, and continuing efficacy. Lead gap assessment audits and PAI readiness inspections at Fresenius Kabi USA facilities as needed. External Audits Lead external audits of Fresenius Kabi suppliers (Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, Contract Laboratories, and all Services). Develop audit plans, conduct quality audits, prepare audit reports, and communicate findings, including compliance risk. Recommends approval or disapproval of suppliers based on compliance assessment. Review and evaluate supplier’s audit response against current industry standards, regulations, and guidelines to assure compliance. Drive closure of corrective and preventive actions to assure sufficient controls are in place by the supplier to meet Fresenius Kabi specifications and quality requirements. Follow up on prior audit recommendations to ensure implementation and compliance. Assist in maintenance of the annual internal and external audit schedules as requested by management. Lead For-Cause audits of external suppliers as requested by management. Lead and / or assist the development of compliance and quality training as required. Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks. Maintain audit files and databases to ensure all documentation is current, complete, and accurate. Assumes additional duties and responsibilities as assigned.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
Requirements
Minimum of a bachelor’s degree in sciences (Masters or higher preferred) with a minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical or biotechnology industries preferred, but combination with medical device experience is acceptable. Certificate as a CQA Auditor, CQE, etc. is preferred.
• Must have at least 5+ years of extensive experience in pharmaceutical and / or biotechnology quality audits including both external and internal auditing. At least five (5) years of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, GMP and other GxP regulations.
• Requires a display of in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
• Proven ability to lead teams and handle project management activities without supervision.
• Must be flexible and able to travel domestically and / or internationally up to 50% of the time.
• Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities / assignments.
• Must demonstrate effective communication skills and technical writing ability.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.