Quality Management System Oversight Lead

Job 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**: **Quality Management System (QMS)Support processes** - Support the execution of Parexel Quality's strategy and Parexel's QMS - As assigned, support execution of the strategic and tactical goals of QMSO for the key QMS elements, including, but not limited to: QMS infrastructure, Quality Issue Management, Management Review, Change Management, Process Optimization, Controlled Documents, Knowledge Management, and Risk Management. - Work to continuously improve Parexel’s QMS. - Maintain a familiarity with Parexel QMS-related systems and related - Provide coaching, mentoring and constructive feedback to QMSO staff as required. - Manage projects and initiatives as assigned, including participants, reporting and escalations as needed. Ensure that project / initiative resources are adequate. If they are not, escalate and either obtain the necessary resources or reprioritize work according to available resources. - 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. Consider process for effectiveness measurement. - Provide technical knowledge and oversight (including Quality eQMS applications business leadership) and serve as an escalation point where appropriate. - Maintain a positive, results oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork - Remain informed about developments in relevant regulations and guidelines. - Support Operations staff in the use of automated quality systems; summarize automated quality system reports and provide metrics as appropriate. - Work with the relevant training functions including Learning & Development. Assist with the development or enhancement of training materials as assigned. **Global Organization Support** - Present QMS to clients, auditors and regulatory inspectors - Lead cross functional improvements projects as required **Skills:** - Excellent interpersonal, verbal and written communication skills - Customer focused approach to work - A 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 to value the importance of 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 and responsibility for work assigned - IT literate – Experience with Microsoft based applications and a general knowledge of PC functions - Culturally aware and ability to think and work globally - English proficiency (written and oral English) **Knowledge and Experience**: - 5 to 8 years work experience - Substantial experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in the areas of QMS support required - Knowledge of GxP compliance as required - Relevant experience in Quality Management - Technology / Business Operations experience, as appropriate, 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 disciple preferred.