QA Compliance & Supplier Risk Lead (Hybrid)

RXinsider LTD.; Leyden Township (IL); Hybrid; USD 135,000 - 142,000; Full time

Benefits offered by this job

Bonus plan with target 10% of base

401(k) with company contributions

Paid vacation, holidays and personal

Health benefits: medical, dental, vis

Job summary

Fresenius Kabi is seeking a Manager, QA Compliance to support regulatory, ISO, and global compliance efforts. This hybrid role requires onsite presence three days per week and collaboration with global teams on supplier management, internal audits, and quality agreements.

The role includes coordinating external audits, maintaining QA databases, and preparing monthly management reviews. Candidates should have 8+ years in QA/QC within regulated pharma, GMP knowledge, and strong leadership in

Qualifications

• Must have a Bachelor's degree in the sciences with 8+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry.
• Must have an in depth knowledge of current GMP and related quality systems.
• Must possess strong leadership, communication, interpersonal skills, negotiation and problem resolution skills.
• Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs.
• Must be able to function independently with minimal supervision.
• The 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.

Responsibilities

• Assist with coordinating and facilitating activities associated with supplier management program and support qualification of new and existing suppliers
• Assist with annual external audit plan with Global Procurement
• Coordinate,perform, and assist team members with supplier qualification activities
• Coordinateand maintain Approved Vendor List
• Assist and support local, regional, and global departments with their questions/requests relating to suppliers
• Perform or assist with supplier risk assessment for non-compliance (i.e. FDA WL, etc.) inspection outcome
• Collaboratewith cross-functional groups and complete supplier (re)qualification activities
• Interfacewith suppliers for audits (on-site, virtual, hybrid, or document) and requests (re)qualification documentation, as needed
• Perform supplier (re)qualification audit, as needed
• Collect and review supplier (re)qualification documentation
• Prepare supplier (re)qualification reports orassessment/evaluationreports
• Update and maintain regional (US QA Compliance) supplier tracking databases
• Update global supplier tracking databases
• Perform investigative task in KabiTrack for supplier change notification and manage until closure
• Assist with coordinating and facilitating activities associated with Regional internal audit program
• Perform annual risk assessment for annual internal audit plan
• Assure internal audits are scheduled, conducted, and closed
• Participatein internal audit as a Lead or Co-auditor
• Plan, prepare, and conduct internal audit
• Collaborateas Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure
• Interfacewith auditees
• Update and maintain internal audit tracking database
• Assist with coordinating and facilitating activities associated with Quality Agreement
• Coordinateand manage the update to Global Procurement Quality Agreement database
• Coordinateand participate in quarterly Global Procurement Quality Agreement review
• Coordinateand perform regional periodic review of Quality Agreements
• Coordinate,negotiate, and support supplier Quality Agreement according to defined business relationship with suppliers
• Coordinate,negotiate, and support inter-company quality agreement according to defined business relationship with other non-FK USA entities
• Coordinate,negotiate, and collaborate with cross-functional groups and/or suppliers to draft, review, and/or finalize quality agreement
• Update global and regional Quality Agreement databases
• Assist with preparing monthly management review presentation
• Coordinate monthly supplier data for product APQR as requested from Production Units
• Assist and perform Implementation Assessment for Instructive Global QM Documents
• Provide and support Annual Supplier EvaluationCoordinateand assist team members in supporting internal, external, customer, and regulatory inspection, as needed
• Support maintenance or process improvement of programs for supplier management, internal audit, and quality agreement, as needed
• Act as back up in the absence of Senior Manager, with support from VP, NAM Quality

Skills

Leadership

Communication

Negotiation

Problem solving

English proficiency

Education

Bachelor's degree in sciences

Tools

KabiTrack

Job description

Fresenius Kabi is seeking a Manager, QA Compliance to support regulatory, ISO, and global compliance efforts. This hybrid role requires onsite presence three days per week and collaboration with global teams on supplier management, internal audits, and quality agreements.

The role includes coordinating external audits, maintaining QA databases, and preparing monthly management reviews. Candidates should have 8+ years in QA/QC within regulated pharma, GMP knowledge, and strong leadership in