Senior Compliance Manager - fully remote!
reputed company is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. reputed company does not hire directly for these jobs, but promotes jobs on reputed company on behalf of its direct clients, recruitment ad agencies, and marketing partners. reputed company partners with DirectEmployers to promote this job for reputed company. Clicking "Apply Now" or "Read more" on reputed company redirects you to the job board/employer site. Any information collected there is subject to their terms and privacy notice. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At reputed company team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, and supporting our customers' medical reputed company inquiries. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to reputed company a difference in our world while building a fulfilling career with us. What will you do in this role? Develops and executes quality and compliance strategies and initiatives across the organization, including promoting awareness of quality and regulatory compliance standards and trends. Oversees governance and compliance management processes including quality events, serious breach events and suspected scientific misconduct events. Develops and maintains quality and compliance guidance/reference materials and tools and provides expertise to advance the vision of the department. Leads quality and compliance processes and engages with cross-departmental staff to ensure appropriate execution and completion (e.g., quality events, serious breach events, suspected scientific misconduct events, supports inspections and audits) Develops guidance and reference information, repositories and communication channels (e.g., requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents or quality management systems training) Creates formal networks with key contacts across the department. Qualification Requirements Education Requirements: Bachelor's degree is required. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Experience Requirements Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 10+ years') or equivalent combination of education, training, & experience. Experience Working With GCP Is Required. Demonstrated ability to use critical thinking is required. At least 2 years in Clinical Quality, GCP Compliance or reputed company is preferred. Experience in CAPA, root cause analysis, and deviation management is preferred. Demonstrated ability to communicate reputed company compliance issues clearly and effectively is preferred. Comfortable working in a matrix organization and managing cross-functional customers is preferred. Prior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is preferred. Knowledge, Skills And Abilities Expertise in applicable GxP and appropriate regional regulations Extensive knowledge of the clinical trial process Expert knowledge of SOPs and WPDs Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) Strong training/mentoring experience of staff on a variety of process/topics Strong attention to detail Effectively works independently or in a team environment Highly developed problem solving, risk assessment, and impact analysis skills Strong negotiation and conflict management skills Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load Strong computer skills; ability to learn and become proficient with appropriate software Proven flexibility and adaptability 0-25% travel may be required. Location: Fully remote, ideally East Coast . Relocation assistance is NOT provided.
- Must be able to pass a comprehensive background reputed company, which includes a drug screening. Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation and support patients in need. #StartYourStory at reputed company, where diverse experiences, backgrounds and perspectives are valued. Apply today! reputed company is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Accessibility/Disability Access Job Seekers with a Disability: reputed company offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability reputed company technical issues will not receive a response. reputed company is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. If you have questions about this posting, please contact support@reputed company.com Apply tot his job
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