Manager, QA Compliance

freseniusglobal; Melrose Park (IL); Hybrid; USD 135,000 - 142,000; Full time

Benefits offered by this job

401(k) plan with company contributions

paid vacation

holiday and personal days

employee assistance program

health benefits to include medical, Rx

Job summary

Fresenius Kabi in the United States seeks a Manager, QA Compliance to support regulatory, ISO and global compliance initiatives. You will assist the Senior Manager with supplier management, internal audits, and quality agreements, and serve as a back-up when needed.

The role encompasses coordinating supplier qualification activities, audit planning, and QA documentation in a hybrid work setting with onsite days. Strong GMP knowledge and cross-functional leadership are essential for success.

Qualifications

• Bachelor’s degree in the sciences with 8+ years in QA/QC in pharmaceutical or related regulated industry.
• Strong knowledge of current GMP and related quality systems.
• Proven leadership, communication, negotiation, and problem-solving skills.

Responsibilities

• Coordinate supplier management activities and qualification of new and existing suppliers.
• Support annual external/internal audits and assist with audit planning and execution.
• Coordinate and manage Quality Agreements across regional/global teams and updates.
• Prepare monthly activities and reports for supplier performance and QA compliance reviews.
• Act as back-up to Senior Manager and liaise with VP, NAM Quality as needed.

Skills

Leadership

Communication

Negotiation

Problem solving

Organization

Education

Bachelor's degree in the sciences

Job description

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.

• $135K - $142K based on experience
• Position is eligible to participate in a bonus plan with a target of 10% 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.
• Benefits offered include:
  • 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
• Hybrid role: Onsite 3 days per week
• 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.

Responsibilities

Supplier Management

• 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
• 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

Internal Audit Program

• 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

Quality Agreement

• 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
• 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

Other Activities

• 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

• 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 successf