Posting Title Clinical Quality Assurance Manager

Job ID	118779BR
Division	Over The Counter
Business Unit	Over The Counter
Country	USA
Work Location	Parsippany, NJ
Company/Legal Entity	Novartis Consumer Health
Functional Area	Production
Job Type	Full Time
Employment Type	Regular
Job Description	Job Purpose: Will be responsible for providing quality and compliance oversight of clinical activities, with related clinical development, pharmacovigilance, and regulatory submissions involvement, ensuring that activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and Novartis established quality standards and practices in an efficient and expeditious manner. Major Accountabilities: • Plans and conducts global clinical audits independently or as a team in a lead or support role. Communicates audit findings both verbally and in writing; utilizes approved electronic audit systems proficiently, evaluates and follows up on the appropriateness and completeness of corrective action plans until closure. Audits are either routine or for-cause/directed and can include: * Clinical systems and/or processes * Investigator sites * Third party vendors * Regulatory submission-related documents • Supports primarily clinical teams, leads quality projects or initiatives as required cross-functionally and/or across business units as a subject matter expert to provide compliance/ QA related guidance and oversight. • Actively participates in the SOP and regulatory submission document reviews and approval processes. • Supports, manages, leads and/or hosts regulatory inspectional activities globally including pre, during and post inspections. • Contributes to audit scheduling and planning, and refining PVCQA operations, processes, written procedures and tools as needed. • Develops and/or provides clinical quality assurance related training/education to targeted functional units within the organization as needed. • Executes other assigned tasks to achieve PVCQA project-related quality and change objectives
Minimum requirements	Education: • Bachelor of Science degree in a life science Experience: • 10 years of pharmaceutical industry experience with at least 3 years experience in clinical quality assurance and auditing • Working knowledge of applicable GCP regulations and guidelines • Experience working in global and multidisciplinary environments • Must be IT systems literate (MS Word, Excel, & Power Point) and be familiar with audit tracking systems • Ability to travel worldwide approximately 20-30% of the time Novartis Consumer Health, Inc. is an EEO/AA employer M/F/D/V.