responsible for scheduling and leading domestic and international quality audits
Identifies top compliance risks and communicates to Fresenius Kabi Management
lead internal audits of Fresenius Kabi facilities based on the FDA’s System Based Inspection Policy and GMP
develop audit plans, conduct quality audits, prepare audit reports, and communicate findings
Lead / participate in Global / Divisional internal audits of Fresenius Kabi facilities
review and evaluate internal audit response against Fresenius Kabi’s policies and procedures requirements
drive closure of corrective and preventive actions
follow up on prior audit recommendations to ensure implementation and compliance
assist in maintenance of the annual external audit schedules
lead and / or assist with the development of compliance and quality training
revise, review, and write SOPs, checklists, and quality documents

Bachelor’s degree in sciences (Masters or higher preferred)
minimum of 8 years of progressive, challenging QA/QC experience in pharmaceutical or biotechnology industries preferred
Certificate as a CQA Auditor, CQE, etc. is preferred
minimum 8 years of extensive experience in pharmaceutical and / or biotechnology quality audits including both external and internal auditing
at least eight (8)+ years of FDA system-based inspection is required
in-depth knowledge of GMP, sterile drug product manufacturing using aseptic processing or terminal sterilization, and/or API manufacturing
in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard
advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations
experience in leading teams, work as a team, and handle project management activities without supervision
must be flexible and able to travel domestically up to 50% of the time, with limited international travels
demonstrates 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

comprehensive and thoughtfully crafted benefits and programs
401(k) plan with company contributions
paid vacation
holiday and personal days
employee assistance program
health benefits including medical, prescription drug, dental and vision coverage

Quality Assurance Manager

Key skills