Manager, QA Compliance

Job Summary

The Manager, QA Compliance is responsible for supporting the company's short and long term goals for maintaining regulatory, ISO, and global compliance. Assist Senior Manager with coordinating and facilitating supplier management, internal audit, and quality agreement, as well as a back up to the Senior Manager.

Responsibilities

• Assist with coordinating and facilitating activities associated with supplier management program and support qualification of new and existing suppliers
• Will assist with annual external audit plan with Global Procurement
• Coordinate, perform, and assist team members with supplier qualification activities
• Coordinate and 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
•  Collaborate with cross-functional groups and complete supplier (re)qualification activities
• Interface with 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 or assessment/evaluation reports
•  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
• Participate in internal audit as a Lead or Co-auditor
• Plan, prepare, and conduct internal audit
• Collaborate as Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure
• Interface with auditees
•  Update and maintain internal audit tracking database
• Assist with coordinating and facilitating activities associated with Quality Agreement
• Coordinate and manage the update to Global Procurement Quality Agreement database
• Coordinate and participate in quarterly Global Procurement Quality Agreement review
• Coordinate and perform regional periodic review of Quality Agreements
• Will 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 Evaluation
• Coordinate and 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

Requirements

• Bachelor's degree in the sciences with  8+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry.
• Must be able to function independently with minimal supervision

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 contribution, and wellness 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.