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Fresenius Kabi USA · 4 days ago

Sr. Manager, GxP Compliance Officer

Lake Zurich, IL

Full-time

Hybrid

Senior Level, Lead/Staff

$140K/yr - $165K/yr

8+ years exp

Fresenius Kabi USA is a leading pharmaceutical company focused on compliance with US-FDA regulations. The Sr. Manager, GxP Compliance Officer is responsible for ensuring compliance across manufacturing sites and R&D centers, leading quality improvement efforts, and preparing for FDA inspections.

Health Care

H1B Sponsor Likely

Hiring Manager

Carolyn Robles

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 Recognition agreements

Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations

Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products

Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions)

Contribution, execution and management of global projects

Collaborate with other corporate quality functions on the execution of strategic goals

Communicate 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 responsibilities

Qualification

US-FDA complianceCGMP knowledgePharmaceutical industry experienceRisk managementProject managementAnalytical problem-solvingInfluencing skillsCommunication skillsTeam leadership

Required

Minimum of Bachelor's degree required

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

Ability to effectively interact with and influence plant personal and leadership regulators, global partners or affiliates, industry executives, trade organizations

Strong 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

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

Preferred

Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable

Previous experience in executing and/or managing GxP audits or inspections a preferred

Established contacts to US-FDA are beneficial

Benefits

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits to include medical, prescription drug, dental and vision coverage

Life insurance

Disability

Wellness program

Company

Fresenius Kabi USA

Fresenius Kabi is health care company specializing in medical and medical technologies.

Founded in 1996

Lake Zurich, Illinois, USA

1001-5000 employees

http://www.fresenius-kabi.us

H1B Sponsorship

Fresenius Kabi USA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (17)

2023 (17)

2022 (15)

2021 (14)

2020 (22)