QA Project Leader

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA seeks an experienced Project Manager (QA) to lead PMO activities supporting quality systems, compliance, and efficiency across the plant. You will oversee investigation reviews, corrective actions, and implementation to prevent recurrence, aligning with GMP expectations.

The role emphasizes coordinating QA and operations projects, improving BRFT and CRT metrics, and supporting FDA inspections. A strong background in cGMP and ISO requirements is preferred.

Qualifications

• Bachelor degree in science with 3+ years QA/QC experience in pharma or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, regulatory, and ISO requirements.

Responsibilities

• Serve as a PMO and change agent for QA and operations projects.
• Manage projects independently with QA and operations teams for impact.
• Track progress with clear deliverables, deadlines and responsibilities.
• Provide progress reports and escalate issues needing support.
• Lead projects focused on compliance or continuous improvement/simplification.
• Impact: BRFT improvements, CRT, and deviation reduction.
• Analyze quality/manufacturing data and recommend compliance actions.
• Consolidate quality metrics with QA reporting heads.
• Review root-cause analyses and implement effective corrective actions.
• Support regulatory inspections and provide information as needed.
• Prepare and present progress reports for senior management.
• Identify and resolve emerging issues affecting projects or goals.
• Develop contingency plans and ensure health, safety, and quality compliance.

Skills

QA/QC experience

Project management

Quality systems

Regulatory knowledge

Education

Bachelor degree in science

Job description

Job Summary

Collaborates with the Sr. Director, Quality Assurance to provide project management for compliance topics and continuous improvement program management to support the company’s short- and long-term goals for maintaining quality systems, compliance, and efficiency. This includes direct oversight for the evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and release of finished product. This includes oversight for the final review of investigation to ensure product quality, and appropriate implementation of corrective actions in a timely manner to prevent recurrence.

Salary: $90,000 to $110,000

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. Read more about our benefits here.

Responsibilities

• Serve as a change agent performing project management duties (PMO).
• Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team.
• Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities.
• Provide progress reports, assist in removing barriers, and elevate issues when additional support is needed.
• Manage projects that primarily focus on compliance or continuous improvement / simplification category.
• Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT).
• Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management.
• Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements.
• Consolidate quality metrics and reporting in collaboration with respective QA reporting heads.
• Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
• Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors.
• Prepares and presents progress reports for senior management.
• Identify and resolve emerging issues that may impact project or corporate goals.
• Recognize potential threats to project success and elevate issues to senior management.
• Develop and implement contingency plans.
• All 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 their roles and responsibilities.

Requirements:

• Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.

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.