Quality Systems Lead

Quality Systems Lead

Location: Irvine, CA

Category: Quality and Compliance

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

Target PR Range: 58-68/hr DOE

Role Summary

The Quality Systems Lead oversees the global Supplier Notice of Change (NOC) program, coordinating the work needed to assess and resolve proposed supplier changes to manufacturing processes, equipment, materials, parts, or services. The role keeps activities moving, secures participation from the appropriate teams, and gives leadership a clear view of program progress and risk. Functional teams perform the technical assessments and implementation; this role coordinates their progress and overall program execution.

This is an individual contributor role with no direct reports. Success depends on influencing peers, holding contributors accountable for commitments, and escalating barriers that require leadership support. The role also strengthens program governance and translates process data and business needs into practical improvements that support compliance, audit readiness, supply continuity, and data integrity.

Key Responsibilities

• Oversee day-to-day execution of the global supplier NOC program, tracking activities and commitments to improve timely completion and reduce the volume of open NOCs.

• Coordinate participation across Quality, Supply Chain, Regulatory, Engineering, Operations, Sourcing, Research and Development, and Digital Technology so changes receive the appropriate review and follow-through.

• Hold contributors accountable for timelines, status updates, and required actions through clear expectations and consistent follow-up, without direct reporting authority.

• Identify delays, process barriers, ownership gaps, and resource needs. Escalate issues to leadership with a clear explanation of the support or decision required.

• Compile and analyze program data to monitor aging work, turnaround times, and performance against program objectives, and improve visibility into the risk of individual NOCs and the overall portfolio.

• Prepare clear reports and presentations that explain program status, risks, and recommended actions to working teams and leadership.

• Apply and strengthen program governance, standard work, documentation, and sustainment practices while keeping ongoing NOC activities on track.

• Translate business requirements and user feedback into practical improvements to workflows, reporting, digital tools, and automation that reduce administrative burden and improve accountability.

• Required Qualifications

• Bachelor’s degree or equivalent experience in a related field of study.

• 8-10 years of relevant professional experience.

• Experience in Quality Systems, manufacturing, or a related regulated environment, with demonstrated ability to coordinate cross-functional programs, projects, or operational activities.

• Ability to manage competing priorities, influence peers, and hold contributors accountable, including conducting difficult follow-up conversations when commitments are at risk.

• Strong analytical, problem-solving, and continuous improvement skills, including compiling multiple data points and using data to explain progress, risks, and recommendations.

• Proficiency in Microsoft Office, particularly Excel for analysis and PowerPoint for presentations to leadership.

• Clear written and verbal communication with individual contributors and leadership, along with strong stakeholder management skills.

• Experience improving processes, systems, reporting, or workflows.

• Preferred Qualifications

• Medical device industry experience. Candidates from pharmaceuticals, aerospace, automotive, and other regulated industries will also be considered.

• Program or project management experience involving multiple functions and workstreams.

• Experience coordinating changes to parts, services, manufacturing processes, equipment, or materials and understanding their cross-functional impact.

• Supplier Quality or supplier NOC experience, including familiarity with how changes are assessed and resolved.

• Experience supporting digital transformation, business systems, workflow automation, or improvements to quality systems governance.

• A degree in engineering, science, or business. Other fields will be considered with relevant experience.

• Tools and Relevant Change Experience

• Company-specific platforms and supplier NOC workflows can be learned on the job. Coding or software development is not required. Prior experience with corrective and preventive action (CAPA), audits, deviations, or nonconformances is not a prerequisite. Relevant change experience involves operational changes and their cross-functional impact, extending beyond standard operating procedure (SOP) or document updates.

• Interview and Relocation Details

• Interviews are virtual and typically last 30-45 minutes. Team members may participate to provide additional perspectives. Candidates willing to relocate at their own expense may be considered.

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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