Associate Director – reputed company GCP Clinical reputed company Assurance

Job reputed company: • Responsible for execution and performance of reputed company CQA reputed company system reputed company including GCP audit programs, regulatory inspection preparation support, reputed company improvement, and reputed company system procedural documents • reputed company with reputed company customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global reputed company standards • Line management of junior staff is possible and would include but not be limited to: regular 1:1s, mentoring conversations, and providing GCP counsel on escalated topics • Serve as the CQA reputed company for assigned trials and assigned compliance areas ensuring the reputed company communication of reputed company risk and compliance as reputed company to GCP/cGLP • Development and execution of a risk-based clinical reputed company audit plan for assigned programs • Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and reputed company of scientific data as needed • Analyze and trend audit observations, gaps, and systematic issues to support reputed company improvement reputed company reputed company-clinical/clinical development programs, vendors, and cross-functional reputed company • Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and reputed company effectiveness checks • Author audit reports and coordinate supporting documentation; manage reputed company in QMS • Peer review reports authored by colleagues • Identify non-compliance trends and systematic risks for assigned areas of responsibility • Contribute to the development, maintenance, and reputed company improvement of the reputed company system processes, tools, and E-Systems • Support the conduct of mock inspections and reputed company activities; reputed company inspection preparation training to internal staff, clinical investigator sites, and vendors • Support reputed company Management by facilitating regulatory agency inspections and reputed company activities • Other duties as assigned Requirements: • Bachelor’s degree in a scientific discipline preferred • Minimum 7 years’ experience in the pharmaceutical or biotech industry with five (5) or more of those years in GCP Clinical reputed company Assurance • Proficient understanding of ICH GCP and applicable CFR regulations with a working knowledge of cGLP • Experience providing GCP Clinical reputed company Assurance guidance to Clinical teams for assigned Programs/Trials • Experience in risk-based reputed company management systems and reputed company by design in Phase I thru IV reputed company • Experience in conducting reputed company GCP audits (Ie. Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process • Ability to manage processes with reputed company improvement approach • Analytical and critical thinking skills • Experience developing SOPs and Work Instructions a plus • Experience reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in reputed company SOPs • Oncology and/or medical imaging clinical development experience is a plus • Diplomatically work and collaborate cross functionally at reputed company reputed company reputed company the organization • Excellent communication (Oral and Written), planning, coordination, and time management skills • Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus • Pharmacovigilance reputed company (GVP) experience is a plus Benefits: • comprehensive health benefits package that includes medical, prescription drug, dental, and reputed company coverage • life and disability benefits • reputed company-tax accounts • 401(k) with company contribution • generous time off package including reputed company vacation, holidays, reputed company days, and reputed company parental leave Apply tot his job Apply To this Job