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 : QMSO 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 Clinical Lead, Clinical Operations Lead, Lead CRAs (or equivalent roles) with extensive experience in Quality Events (Quality Issues or Audits/ Inspections Findings) would be considered relevant. 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.