Quality Management System Lead

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in implementing Parexel Quality's strategic initiatives and the Quality Management System (QMS) of Parexel.

• Aid in achieving the strategic and tactical objectives of the Quality Management System Office (QMSO) for essential QMS components.

• Strive for ongoing enhancements to Parexel’s QMS.

• Maintain an understanding of systems related to Parexel QMS.

• Offer coaching, mentoring, and constructive feedback to QMSO personnel as necessary.

• Oversee assigned projects and initiatives, including participant management, reporting, and escalations as required.

• Assist in managing the budget for QMSO.

• Support Corporate Quality with the attendance, preparation, and follow-up for internal and external audits and inspections.

• Collaborate with Corporate Quality to create and/or update quality and process documents, tools, and templates.

• Provide technical expertise and oversight, serving as an escalation point when appropriate.

• Foster a positive, results-driven work environment.

• Present the QMS to clients, auditors, and regulatory inspectors.

• Lead cross-functional improvement projects as needed.

⛳️ Requirements

• 5 to 8 years of professional experience.

• Significant experience in the Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in QMS support is required.

• Knowledge of GxP compliance is necessary.

• Relevant experience in Quality Management Technology or Business Operations is preferred.

• Leadership and/or project management experience is preferred.

• Training experience is required.

• Extensive experience in a global work environment.

• Bachelor’s Degree or equivalent relevant experience is required.

• A background in life sciences or another health-related discipline is preferred.

• A Master’s Degree in a science, technology, or industry-related discipline is preferred.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.

• Paid time off.