Sr. Manager, GxP Compliance Officer

About this role

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: $140,000-$165,000

• 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.

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 subje...