Manager, QA Compliance

Fresenius Kabi USA; Chicago (IL); Hybrid; USD 135,000 - 142,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Dental and vision

Job summary

Fresenius Kabi USA seeks a Manager, QA Compliance to support regulatory, ISO, and global compliance. They will assist with supplier management, internal audits, and quality agreements, acting as a backup to the Senior Manager. Hybrid role onsite 3 days/week with US work authorization.

The role requires a Bachelor’s degree in sciences with 8+ years in QA/QC in pharma, and strong GMP knowledge. Competitive benefits, bonus plan, and growth opportunities are offered as part of a comprehensive

Qualifications

• Must have a Bachelor's degree in the sciences with 8+ years of progressive 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.

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
• 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
• 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

Skills

Leadership

Communication

Negotiation

Problem resolution

Multitasking

Education

Bachelor’s degree in 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.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and 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

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

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
• 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

• 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.

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, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.