Principal Quality Engineer - cGMP Training

Medline; Northfield Township (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Medline in Illinois is seeking an experienced Quality Project Lead to drive initiatives across the quality organization, collaborating with cross-functional teams and external partners to ensure regulatory compliance and robust quality systems. This role bridges design and manufacturing, supporting strategic improvements and cGMP practices across sites.

You will provide technical leadership during investigations, CAPAs, and continuous improvement efforts, with travel up to 30% and a proven track

Qualifications

• Bachelor's degree required.
• 7+ years in pharmaceutical manufacturing or quality assurance.
• Willingness to travel up to 30% domestically and internationally.

Responsibilities

• Lead quality initiatives across the organization and train affected teams on new procedures.
• Improve the QMS for efficiency and stronger regulatory compliance.
• Lead root cause analyses and plan CAPAs with documented evidence.
• Evaluate Cost of Quality and propose cost-saving projects.
• Provide process guidance across sites and corporate functions.
• Lead risk management using methods like FMEA and risk controls.
• Drive cGMP best practices and training across the network.
• Support inspections readiness and regulatory compliance activities.
• Mentor teams and communicate project status to leadership.

Skills

Project leadership

Quality Management

Regulatory compliance

Risk management

Cross-functional teamwork

Travel up to 30%

Education

Bachelor's degree

Job description

Job Summary

Responsible for leading and managing quality projects throughout the quality organization. Collaborate with cross-functional teams, both internal and external to quality, and serve as a subject matter expert to ensure compliance to applicable regulations and standards; Support strategic initiatives with the goal of continually improving our global quality system as well as emergency support when unexpected challenges arise that meet your area of expertise; Plays a vital role in bridging the gap between conceptual design and practical manufacturing, contributing to the efficient and cost-effective production of high-quality products.

Job Description

MAJOR RESPONSIBILITIES:

• Lead project initiatives throughout the quality organization by collaborating with cross-functional teams. Present project deliverables to the lead team as well as communicate/train affected groups on procedural or process changes.
• Identify, lead and drive opportunities to improve the Quality Management System through increased efficiency or more robust compliance to applicable regulations.
• Leverages their understanding of the QMS to lead root cause activities as well as planning the corrective or preventative actions for critical quality concerns. Ensure actions are completed in a timely fashion with appropriate resources and supporting evidence is properly documented.
• Evaluate Cost of Quality metrics to identify cost savings opportunities. Propose projects to the lead team and execute on the implementation of approved projects.
• Manage and provide process guidance for manufacturing or corporate functions, ensuring process management is consistently applied across all corporate divisions, manufacturing sites and groups.
• Proficiency in identifying, assessing, and managing risks associated with product and/or process development projects. Apply industry-standard risk management tools and techniques (e.g., FMEA, fault tree analysis) to identify and mitigate potential risks. Complete necessary documentation related to risk management activities, including risk assessment, risk mitigation strategies, and risk control implementation.
• Drive development and deployment of enterprise cGMP best practices across Medline's Pharmaceutical network.
• Design and implement training programs that strength cGMP behaviors including an understanding of "why" cGMP activities and process controls are important.
• Provide technical leadership and training to support sustained cGMP compliance across sites.
• Lead and support investigations, deviations, CAPAs, and continuous improvement initiatives.
• Support inspection readiness and regulatory compliance activities across the organization.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor's degree.

Certification / Licensure:

• None

Work Experience:

• At least 7 years of experience in pharmaceutical manufacturing / some medical device engineering and/or quality assurance preferred.

Knowledge / Skills / Abilities:

• Position requires travel up to 30% of the time for business purposes (domestic and international).
• Demonstrated leadership abilities, including:
  • Lead project teams by providing structure and delegating tasks in accordance with the skills of each team member
  • Promote an engaging atmosphere within the group that helps foster open dialogue and is inclusive to all
  • Independently manage projects to ensure deadlines are met and any delays are communicated/mitigated proactively
• Demonstrated Critical Thinking and Problem Solving abilities, including:
  • Collaborating with cross-functional teams and internal customers as a key contributor and/or project manager, driving solutions and producing results for major projects such as QMS Improvements, Cost Savings opportunities, Process alignments, software launches/improvements; ensuring inputs and stakeholder needs are met
  • Managing and engaging on multiple projects with competing needs and resource requirementsChange management and leadership experience associated with process and QMS enhancements
  • Improving organizational efficiencies by solving challenging and ambiguous problems with system and process solutions
  • Sound judgment, ability to quickly evaluate information to make decisions while mitigating risk to the business. Capable of maintaining a sense of calm during crisis management to identify and present unique solutions.
  • Exposure to statistical techniques and data collection methods to aid decision making based on data
  • Good understanding of auditor expectations, able to properly document actions taken and support them through objective evidence. Able to identify compliance gaps and set forth actions to correct deficient areas.
• Demonstrated Communication and Interpersonal abilities, including:
  • Communicating project status and complex subject matter to directors, vice presidents and executive members, to provide insight into the current state of the business or project, and as required, inspire the envisioned end state
  • Understanding of when written or verbal communication