Sr Manager, GxP Compliance Officer

Location: Melrose Park, IL

Job Summary

The Sr. Manager, GxP Compliance Officer (GCO) assures that all manufacturing sites and R&D Centers having activities with US-FDA are in compliance with US-FDA regulations, including but not limited to, cGMPs, cGLPs, and electronic records. This includes global facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and promotes company-wide US-FDA quality and compliance improvement and compliance improvement efforts.

Salary Range: $172,000-$192,000 based on experience

• Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

• Responsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical division
• Evaluation of Investigations and Changes that could have an impact on regulatory commitments
• Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc
• Support plant on strategy and compliance plans for identified gaps
• Lead/manage working groups to ensure mitigation plans are executed
• Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to:
• Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts
• Performance of mock inspections to evaluate the plants readiness for FDA inspection
• Design and deliver need-based training to specific plants in response to identified gaps
• Direct participation and support during US-FDA inspections (inspection room and back office), including:
• Immediate guidance and support during inspections
• Support and guidance in preparing response to FDA-483 observations
• Independent review of Effectiveness of assigned FDA-483 CAPA
• May also include inspections by local authorities when related to Mutual Recogition agreements
• Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations
• Additional Locations: Chicago, IL, Illinois