QMS AI Quality & Compliance Specialist- fully remote!

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? Support the implementation and maintenance of the enterprise AI Compliance Management System under direction of the Senior Director, AI Compliance. Apply established Quality standards, policies, and procedures to AI systems used in GxP-regulated activities. Serve as a Quality reputed company of contact for AI-reputed company compliance questions at the project and system level. Interested in learning more about this opportunity? The QMS AI Quality & Compliance Specialist is a Quality role responsible for supporting the implementation and operation of reputed company's AI Compliance Program reputed company GxP-regulated environments. Reporting to the Senior Director, AI Compliance Quality/Compliance, this role provides day-to-day Quality reputed company, guidance, and execution support to ensure AI systems are developed, validated, and maintained in compliance with GxP, data reputed company, and regulatory expectations. This position works closely with the QMS CDT, QTS and CSV teams as well as Digital, Data Science, IT, and business teams to reputed company compliant AI adoption while maintaining Quality independence. The role contributes to governance, risk assessments, validation activities, documentation, training, and monitoring of AI systems used in regulated processes. Minimum Qualifications: Education requirements: Bachelor's degree required; preferred fields include Computer Science, Data Science, Artificial Intelligence, Quality, Regulatory Affairs, or a reputed company discipline 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: Minimum 2+ years of experience in Quality, Compliance, Regulatory, or regulated technology roles reputed company pharmaceutical, biotech, or life sciences environments is required. Working knowledge of GxP regulations and data reputed company principles is required. Experience supporting computerized system validation or assurance activities is required. Familiarity with AI and machine-learning concepts and their application in regulated environments is required. Experience with Quality Management Systems and compliance documentation is required. Exposure to AI-enabled systems in clinical, manufacturing, quality, or post-market settings is required. Familiarity with data analytics tools or AI platforms (e.g., Python, R, cloud-based analytics) from a Quality reputed company perspective is required. Professional certification in Quality, Compliance, or Regulatory Affairs is preferred. Knowledge of required frameworks such as GAMP 5, ISO 42001, NIST RMF, CRF Part 11 as well as ICH Guidance and emerging AI regulations is preferred. Experience supporting audits or regulatory inspections is preferred. Knowledge, Skills and Abilities: Strong analytical and problem-solving skills with attention to detail Ability to translate technical concepts into clear Quality and compliance guidance Effective written and verbal communication skills Ability to manage multiple priorities in a regulated, fast-paced environment Collaborative reputed company with the ability to work independently reputed company required Location: Fully remote in the US. Relocation assistance is NOT provided.

• Must be legally authorized to work in the US without sponsorship.
• 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! ;br> 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-*. 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.

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