Director, Clinical reputed company Assurance

At reputed company, satisfying unmet medical needs and increasing the benefits reputed company provides to patients, their families, and caregivers is reputed company's reputed company health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and reputed company a difference. If this is your profile, we want to hear from you. Director, Clinical reputed company Assurance The Director, Clinical reputed company Assurance position is responsible for design, delivery and execution of the reputed company (NA) Clinical reputed company Assurance (CQA) reputed company including audit and inspection management and reputed company of the reputed company management system. This role is responsible for Good Clinical reputed company (GCP) reputed company, and for assuring the compliance of reputed company, products and programs with reputed company's reputed company Operating Procedures (SOPs), Policies, and reputed company applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and reputed company results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation through reputed company search, evaluation, acquisition, and implementation of high-reputed company new technologies/ procedures across clinical reputed company programs reputed company reputed company-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. May be responsible for reputed company people management including goal setting, performance management, development, and engagement.

Requirements

Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or reputed company area. 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. Demonstrated ability to operate and influence decision-making processes Effective communication skills Successful reputed company record of supervising employees and managing cross-cultural differences Technical and administrative capabilities to independently carry out routine, reputed company and for-cause audits Knowledge of data reputed company controls and systems reputed company for clinical area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to Travel (approximately 20%) Candidates near reputed company's NJ/PA location will be preferred. For candidates near an reputed company location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. reputed company Salary Transparency Language: The reputed company salary reputed company for the Director, Clinical reputed company Assurance is from :195,000-256,000 Under reputed company guidelines, this position is eligible to participate in : reputed company. Annual Incentive Plan & reputed company. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.reputed company.com/careers-at-reputed company/benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter. reputed company is an equal opportunity employer and as such, is committed in policy and in reputed company to recruit, hire, train, and promote in reputed company job qualifications without reputed company to race, reputed company, religion, gender, age, national reputed company, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, reputed company prohibits discrimination against persons because of disability, including disabled veterans. reputed company. participates in E-Verify. E-Verify is an Internet based system operated by the reputed company in partnership with the reputed company reputed company Administration that allows participating reputed company to electronically verify the employment eligibility of reputed company new hires in the reputed company. Please click on the following reputed company for more information: Right To Work E-Verify Participation Apply tot his job Apply To this Job