Sr Manager, GxP Compliance Officer

Fresenius Kabi; Melrose Park (IL); On-site; USD 172,000 - 192,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Health benefits

Employee assistance program

Wellness program

Job summary

Fresenius Kabi USA in Melrose Park, IL seeks a Sr. Manager, GxP Compliance Officer to ensure US-FDA compliance across manufacturing and R&D, including global facilities for US imports. Lead global quality and compliance initiatives and prepare for FDA inspections.

Responsibilities include evaluating investigations, remediation of regulatory risks, training staff, mock inspections, and providing guidance during inspections. Requires 8+ years with FDA experience; travel may be required.

Qualifications

• Bachelor’s degree required; advanced degree desirable.
• 8+ years of US-FDA/pharma experience.
• Knowledge of cGMPs, ICH guidelines and regulatory compliance.
• Experience in executing GxP audits or inspections preferred.
• Ability to interact with regulators and senior stakeholders.
• Willingness to travel domestically and internationally.
• Strong analytical and leadership skills.

Responsibilities

• Lead global compliance activities for the pharmaceutical division.
• Evaluate investigations and changes impacting regulatory commitments.
• Identify and remediate plant quality and compliance risks.
• Support plants with gap analysis and compliance plans.
• Lead working groups to implement mitigation actions.
• Prepare sites for upcoming US-FDA inspections; train staff.
• Conduct mock inspections and provide inspection readiness training.
• Participate in FDA inspections and back-office support.
• Monitor new FDA cGMP trends and develop strategies.
• Harmonize cGMP and quality processes; manage global projects.
• Prepare global quality management documents and SOPs.
• Collaborate with corporate quality to achieve strategic goals.
• Communicate findings and risks to management.

Skills

GxP compliance

Regulatory affairs

FDA liaison

Quality assurance

Risk management

Project management

Audits/Inspections

Bilingual English/Spanish

Education

Bachelor's degree

Advanced degree

Job description

Job SummaryThe 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.ResponsibilitiesResponsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical divisionEvaluation of Investigations and Changes that could have an impact on regulatory commitmentsIdentification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etcSupport plant on strategy and compliance plans for identified gapsLead/manage working groups to ensure mitigation plans are executedResponsible 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 expertsPerformance of mock inspections to evaluate the plants readiness for FDA inspectionDesign and deliver need-based training to specific plants in response to identified gapsDirect participation and support during US-FDA inspections (inspection room and back office), including:Immediate guidance and support during inspectionsSupport and guidance in preparing response to FDA-483 observations Independent review of Effectiveness of assigned FDA-483 CAPAMay also include inspections by local authorities when related to Mutual Recogition agreementsResponsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectationsStrategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi productsPreparation of global quality management documents (e.g. SOPs, guiding documents, working instructions)Contribution, execution and management of global projectsCollaborate with other corporate quality functions on the execution of strategic goalsCommunicate findings and risks to plant management as well as senior quality management 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 responsibilitiesRequirements Minimum of Bachelor’s degree required. Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable.Accomplished US-FDA compliance expert.Experience: 8+ years including practical experience in pharmaceutical industry and/or US-FDA.A thorough knowledge of drug transfer processes, manufacturing processes for aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines, regulatory compliance.Professional experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, root cause analysis and investigation management is required to be successful in this position.Previous experience in executing and/or managing GxP audits or inspections a preferredAbility to effectively interact with and influence plant personal and leadership regulators, global partners or affiliates, industry executives, trade organizations.Established contacts to US-FDA are beneficialStrong analytical problem-solving experience is essential. Demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable.Ability to manage multiple complex situations, where precedent may not have been established. Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual.Ability to travel frequently (both domestically and internationally) is required.Project Management, working in a Quality Management System and strong communication skills are required for this position.Bilingual English/Spanish preferredThe Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.Additional InformationWe 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.