- Merck & Co. (Lower Gwynedd, PA)
- …and engage in cross function end to end process development with science and IT .The candidate must have hands-on experience with the design, develop and transfer of ... to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected.-Education:… more
- Bristol Myers Squibb (Princeton, NJ)
- …**Qualifications & Experience:** + A minimum of 12-15 years of experience in IT Compliance and computer systems validation (CSV) in the pharmaceutical industry, ... Evaluate, propose, and implement technology solutions that improve digitization, compliance , and productivity. Serve as a CSA subject-matter- expert...including at least 5 years of managing/overseeing IT Compliance and CSV projects + Good… more
- IQVIA (Mooresville, NC)
- …Systems Audit activities in IQVIA globally, or its affiliates, to assess compliance with applicable GXP regulations/ GAMP (Good Automated Manufacturing ... QA activities. + Keep current with regulatory developments, including GxP , 21 CFR Part-11, EU Annex 11, GAMP, ICH,...ensure IQVIA meets or exceeds industry best practices for compliance and validation. + Collaborate with other IT… more
- Sanofi Group (Framingham, MA)
- … Compliance Engineer owns and ensures a robust investigations process, uses expert knowledge of compliance and GXP manufacturing processes to ... **Job Title:** Principal Manufacturing Compliance Engineer **Location:** Framingham, MA **About the Job**...inspections + Represent investigation team during internal and external GxP audits. + Partner with cross functional teams and… more
- BeiGene (San Mateo, CA)
- …stakeholders to implement changes that streamline processes, reduce complexity, and improve compliance across GxP areas. + Monitor the effectiveness of ... digital innovation and change management. The Senior Manager will ensure cross- GxP strategic alignment and facilitate communication between global teams in support… more
- Bristol Myers Squibb (Princeton, NJ)
- …**Qualifications & Experience:** + A minimum of 2-4 years of experience in IT Compliance and computer systems validation (CSV) in the pharmaceutical industry ... strategies. Evaluate, propose, and implement technology solutions that improve digitization, compliance , and productivity. Serve as a CSA subject-matter- expert … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …strategy as the global process owner. The incumbent functions as a subject matter expert for quality and compliance issues. This role provides support to the ... associations as appropriate + Perceived as thought leader possessing subject matter expert knowledge of assessing compliance to global regulations + Manages… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of the most challenging global health issues. The Director, Quality and Regulatory Compliance , Compliance Programs is responsible for helping to shape, implement ... and support the maintenance of the BD Q&RC compliance programs. This role contributes to the definition of...This role requires demonstrated experience with the US FDA GXP regulations and have a working knowledge on quality… more
- Kelly Services (Rochester, MN)
- … inspection readiness. + Conduct audits on raw data and final reports for compliance with GxP , study protocols, and laboratory procedures. + Monitor and ensure ... + Review documentation for adherence to quality standards. + Ensure compliance of facilities, equipment, processes, and procedures with regulations and company… more
- Vera Therapeutics (Brisbane, CA)
- …Systems Architecture. * Maintains the Systems Roadmap and Digital Landscape documents. * Compliance and Security: Ensure all IT systems and processes comply with ... data and privacy. * Serves as a subject matter expert in identification, evaluation, design, development, and deployment of...as it pertains to regulated product delivery from an IT and compliance perspective. * Experience working… more
- Catalent Pharma Solutions (Morrisville, NC)
- …responsible for re-designing future state landscape for CSS Business Unit, ensuring compliance with GxP regulations and robust Computer System Validation (CSV) ... processes. Expert knowledge in various technologies including Cloud PaaS, IaaS,...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… more
- System One (St. Joseph, MO)
- …a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes. Requirements ... and validation in the healthcare industry. + Knowledge of GxP regulations (eg 21 CFR Part 11, Annex 11)...plan. System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are… more
- Lilly (Indianapolis, IN)
- …of the Advisor MQO Corporate role is to be the quality expert for their given area of responsibility (regional/affiliate, portfolio and/or functional business ... execution of regulations on a local, regional, and global level ensuring compliance and inspection readiness. + Accountable for the development and implementation of… more
- Lilly (Indianapolis, IN)
- …Advisor / Sr. Advisor Global MQO role is to be the quality expert for their given area of responsibility (regional/affiliate, portfolio and/or functional business ... execution of regulations on a local, regional, and global level ensuring compliance and inspection readiness. * Accountable for the development and implementation of… more
- AbbVie (North Chicago, IL)
- …regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance , and data security. Qualifications + Bachelor's Degree ... YouTube and LinkedIn. Job Description As a recognized multidisciplinary expert , drives functional performance by designing and implementing solutions aimed… more
- Charles River Laboratories (Wilmington, MA)
- …of people across the globe. Whether your background is in life sciences, finance, IT , sales or another area, your skills will play an important role in the ... you can feel passionate about. **Job Summary** Serve as a Subject Matter Expert for mechanical utility systems and energy optimization. Support all business units… more
- Kelly Services (Tampa, FL)
- …monthly reports. + Ensure Manufacturing and QC laboratory operations are in compliance with the global regulatory requirements. + Support internal audits and assist ... + Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems. **Qualifications:**… more
- AbbVie (Worcester, MA)
- …regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance , and data security. Qualifications + Bachelor's Degree ... Technology group and help drive forward our Digital Transformation. This role is an expert in the treatment of "context" of scientific data. On top of proper… more
- Eurofins (Lancaster, PA)
- …best performing stocks in Europe over the past 20 years. + Subject Matter Expert (SME) - Maintain instrument/software in a validated state at all times. Perform ... and routine qualification testing. Install, configure software for electronic record compliance . Perform testing to identify gaps and develop remediation as… more
- Kelly Services (Mooresville, IN)
- …one s job, and maintain the highest levels of professionalism, ethics and compliance at all times. + Enter inventory transactions: create re-work work orders, cycle ... Experience working in an FDA regulated environment is preferred, GXP and GMP experience is a plus **Apply now...Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical… more
