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Parexel

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Quality Management System Oversight Lead

System AdministratorSystem AdministratorFull TimeRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

22 hours ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Quality Management System Oversight Lead

Parexel

Role Description When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: - Support processes and execution of Parexel Quality's strategy and Parexel's QMS. - Support execution of the strategic and tactical goals of QMSO for key QMS elements, including: - QMS infrastructure - Quality Issue Management - Management Review - Change Management - Process Optimization - Controlled Documents - Knowledge Management - Risk Management - Work to continuously improve Parexel’s QMS. - Maintain familiarity with Parexel QMS-related systems. - Provide coaching, mentoring, and constructive feedback to QMSO staff as required. - Manage projects and initiatives as assigned, ensuring adequate resources and escalating as needed. - Support management of the QMSO budget. Parexel Quality Department Support: - Support Corporate Quality in the attendance, preparation for, and follow-up of internal/external audits and inspections as required. - Work with Corporate Quality to develop and/or update quality/process documents, tools, and templates. - Provide technical knowledge and oversight, serving as an escalation point where appropriate. - Maintain a positive, results-oriented work environment, building partnerships within the group and across the organization. - Remain informed about developments in relevant regulations and guidelines. - Support Operations staff in the use of automated quality systems; summarize reports and provide metrics as appropriate. - Work with relevant training functions including Learning & Development to assist with training materials. Global Organization Support: - Present QMS to clients, auditors, and regulatory inspectors. - Lead cross-functional improvement projects as required. Qualifications - Excellent interpersonal, verbal, and written communication skills. - Customer-focused approach to work. - Flexible attitude with respect to work assignments and new learning. - Ability to manage and prioritize tasks efficiently and accurately. - Willingness to work in a matrix environment and value teamwork. - Understanding of audit/inspection process. - Ability to lead projects and teams. - Strong ability to analyze and interpret data. - Attention to detail and advanced organizational skills. - Ability to work independently and take ownership of work assigned. - IT literate – Experience with Microsoft applications and general knowledge of PC functions. - Culturally aware and ability to think and work globally. - English proficiency (written and oral). Requirements - 5 to 8 years work experience. - Substantial experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in QMS support. - Knowledge of GxP compliance as required. - Relevant experience in Quality Management. - Technology/Business Operations experience preferred. - Leadership and/or project management experience preferred. - Training experience required. - Substantial experience working in a global environment. Education - Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred. - Master’s Degree in a science, technology, or industry-related discipline preferred.

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