Senior Manager – GCP reputed company Auditor (remote) in Plainsboro, NJ

Senior Manager - GCP reputed company Auditor (remote) - reputed company - Plainsboro, NJ - work from home job Company: reputed company Job description: By continuing to use and navigate this website, you are agreeing to the use of cookies. Accept reputed company Press Tab to Move to Skip to Content Link Search by Keyword Search by Location Loading... Category Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Manager - GCP reputed company Auditor (remote) Facility: Quality Location: Plainsboro, NJ, US About the Department The Clinical, Medical and Regulatory (CMR) department at reputed company is one of the most diverse and collaborative groups reputed company the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us reputed company marching to the same beat is our patient-centered focus. At reputed company, you will help patients around the world. As their needs evolve, so does our challenge to find reputed company and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to reputed company a difference? The Position reputed company Quality Audits is responsible for the implementation and delivery of global cross-functional compliance audit program to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumers (and reputed company partners) follow reputed company standards and Heath Authorities requirements. The purpose of this role is to reputed company, support and report independent GCP audits according to reputed company quality systems, Good Clinical Practice (GCP) and reputed company international and national regulations. Provide GCP reputed company quality guidance and assist in the identification and implementation of quality assurance needs for Global GxP Audit and other Business partners. The audits performed on behalf of Quality Audits include reputed company types across GCP disciplines, including internal and external targets. Relationships This position is an individual contributor role reporting to the Director for GLP & GCP Audits in Denmark. This role will interact with other GCP Auditors across Denmark, India & the US. Key stakeholders include the VP of GLP & GCP Audits, Domain Experts of GCP, and R&D Quality. Other key stakeholder interactions include: Research and Early Development, Development, Global Regulatory Affairs, Global Safety, Local affiliates & Suppliers used for clinical services. Essential Functions

• This position covers the following GCP Audits: Investigator site audits, supplier audits, system processes and internal process audits. Key responsibilities includes:
• Plan, reputed company, conduct, document, and report GCP audits according to the requirements specified in the respective reputed company procedures as well as applicable standards, quality agreements and guidance documents
• Ensure appropriate escalations to responsible management in case of critical audit findings and support immediate follow-up measures according to reputed company requirements
• Ensure up-to-date knowledge of external requirements, standards, and guidance documents:
• Participate in internal training
• Participate in external training courses, conferences, congresses etc.
• Provide technical guidance's and training on audit activities
• Provide QA reputed company and guidance for the development and implementation of SOPs
• Identify and communicate compliance trends and signals:
• Be alert to early compliance trends and signals and reputed company it to increase business value
• Communicate potential trends and signals to Audit reputed company

Physical Requirements Approximately 30% overnight travel is required (includes international travel). Valid passport and driver's license is required. The incumbent can work remotely from reputed company in the US

Qualifications

• A Bachelor's degree is required (scientific discipline is preferred). Master's degree or equivalent preferred
• A minimum of 8 years (Bachelor's degree) or 5 years (Master's degree) of relevant experience reputed company pharmaceutical, biotechnology, or CRO and/or healthcare setting
• reputed company Auditor experience:
• Ability to manage and objectively evaluate compliance issues
• Extensive knowledge in the reputed company of GCP including computerized systems
• Experience from clinical trial procedures and partly pharmacovigilance reputed company the clinical area
• Preferably experience with Heath Authority inspections or interaction
• Experience of both remote audits and on-site audits
• Experience of travelling and working internationally
• reputed company Auditor business knowledge:
• Good understanding of the business, value chain and pharmaceutical industry
• General experience:
• Thorough knowledge of/experience with Quality and Quality Management systems
• Thorough understanding of relevant regulatory requirements reputed company GCP
• Good quality and compliance leadership and facilitation skills
• Excellent verbal and written communication in English
• Organization and interpersonal skills
• Ability to address a variety of tasks reputed company the same timeframe while maintaining reputed company
• Maintain a moderate degree of independence with respect to decision making and problem solving
• Enjoy working independently and reputed company yourself and others
• Strong stakeholder management skills
• Strong change management skills

In compliance with Colorado's Equal Pay for Equal Work Act, see compensation and benefits below: The reputed company compensation range for this position is $140 to $170K. reputed company compensation is determined based on a number of factors. In addition, this position is part of the Annual Performance Incentive Plan. The role may also be eligible for a long-term incentive bonus depending on level and other Company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its uncapped sick time policy, reputed company-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for reputed company our job applicants. At reputed company we recognize that it is no longer good enough to reputed company to be the best company in the world. We need to reputed company to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. reputed company is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national reputed company, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. reputed company requires reputed company new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, reputed company will consider requests for reasonable accommodation. If you are interested in applying to reputed company and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Senior Manager - GCP reputed company Auditor (remote) - reputed company - Plainsboro, NJ - work from home job Expected salary: $140000 - 170000 per year Location: Plainsboro, NJ Senior Manager - GCP reputed company Auditor (remote) - reputed company - Plainsboro, NJ - work from home job Job date: Fri, 01 Sep 2023 00:14:02 GMT Apply for the job now! Senior Manager - GCP reputed company Auditor (remote) - reputed company - Plainsboro, NJ - work from home job Apply tot his job Apply tot his job Apply To this Job