Responsible for scheduling and leading domestic and international Corporate Compliance Audits, including internal audits of company facilities and external audits of suppliers in accordance with company policies and procedures. Identifies top compliance risks and communicates to Management. Must be able to function independently with limited supervision.
Lead internal audits of company facilities based on the FDA System Based Inspection Policy and general cGMP. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.
Lead/participate in QMFK internal audits of Fresenius Kabi facilities as required. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings to company management.
Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
Lead gap assessment audits and PAI readiness inspections at company facilities as needed.
Prepare monthly reports of completed activities including trend analysis, if required and submit to the Manager, Corporate QA and Senior QA Management.
Lead external audits of raw material suppliers including Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, and Contract Laboratories. Develop audit plan, conduct quality audit, 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 and guidelines to assure sufficient controls are in place by the supplier to meet specifications and quality requirements. Follow-up on prior audit recommendations to ensure implementation and compliance.
Assist in the maintenance of the annual internal and external audit schedules as requested by management.
Lead for cause audits of external suppliers as request by management.
Assist in and/or lead 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 and complete.
Assume additional duties and responsibilities as assigned.
Must have at least a Bachelor’s degree in the Sciences (Masters preferred) with a minimum of 3-5 yrs. of progressive, challenging QA/QC experience in pharmaceutical, biotech or medical device industries. Certification as a CQA Auditor, CQE etc preferred.
Must have at least 4-5 years of experience in pharmaceutical quality audits including both external and internal auditing. At least one year of FDA system-based inspection is required. In-depth knowledge of Aseptic Processing, cGMP and GLP regulations is required.
Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines and ISO 9001:2008. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
Must display the ability to lead teams and handle project management activities with supervision.
Must be able to travel domestically and/or internationally up to 70% 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.
Additional Salary Information: base salary +annual bonus + travel stipends, full benefits package
Internal Number: LZP00023
About Fresenius Kabi USA
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.