Sr. Manager, FDA Compliance - Chicago, United States - Fresenius Kabi

Description

Job Summary The Sr.

Manager, FDA Compliance (Global Remediation Officer) assures that all plants and I&D Centers having activities with US-FDA are in compliance with US-FDA regulations, including but not limited to, cGMPs, cGLPs, & cGCPs.

This includes foreign 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 global remediation efforts.

Responsibilities Responsible for leading, coordination, verification and tracking of global remediation 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, etc Support 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 observationsIndependent review of Effectiveness of assigned FDA-483 CAPAResponsible for identification of newFDA 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 projectsCommunicate findings and risks to plant management as well as senior qualityAll 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 managementRequirementMinimum 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, strong communication skills are required for this position.

Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

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.

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