- Merck (Boston, MA)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Schrodinger (Cambridge, MA)
- …appropriate oversight of all vendors, including CDMOs and CROs, to ensure regulatory compliance + GMP Responsibilities: + Serve as spokesperson and technical ... looking to hire a **Director, GxP Quality Assurance and Compliance ** to join us in our mission to discover...subject matter quality expert for all matters governed by GMP -related… more
- Fresenius Medical Center (Lexington, MA)
- …(QMS) within the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and ... knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP , ISO 13485) as well as documenting computerized system validation and… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** Subject matter expert leading implementation of state-of-art automation solutions for QC ... internal and external stakeholders to ensure automation designs meet compliance and business requirements. Build effective relationships/partnerships and work… more
- Fujifilm (Boston, MA)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- Kayem Foods, Inc. (Chelsea, MA)
- …safety programs to promote, maintain and enhance our best-in-class processes, ensuring compliance with all relevant local, state and federal food regulations. This ... requires an experienced leader who is a subject matter expert and requires limited direction and will report directly...daily operations to ensure product safety, quality, and regulatory compliance . Participates at all levels of R&D to collaborate… more
- Catalent Pharma Solutions (Chelsea, MA)
- …as Operations, Quality, Product Development, Engineering, and Project Management. As an expert for the validation of cleaning processes, you are responsible for the ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...of experience in the Pharma, Medical Device or any GMP regulated environment required or an equivalent combination of… more
- Fresenius Medical Center (Lexington, MA)
- …compliant with regulatory requirements and meet the needs of our Quality and Compliance teams. They will be an experienced in managing external vendors, software ... team. + Ensure business continuity for the systems + Expert liaison for interface management on daily basis to...progress, and coordinating resources. + Work with Quality and Compliance teams to understand their needs and ensure that… more
- Editas Medicine (Cambridge, MA)
- …of training curricula and the electronic training system. + Perform training compliance periodic metric analysis and reporting to end users and senior management. ... and Quality Control, with solid + understanding of global GMP and cGMP regulations. + Excellent verbal and written...and effectively This role is critical for maintaining our compliance and quality standards in a fast-paced and dynamic… more
- Bristol Myers Squibb (Devens, MA)
- …and collaboration. + Good customer service skills. + Understand regulatory and compliance in GMP requirements. + Understand computer system validation. + ... Digital Plant, and prepare for remediation. + Understand and promote site compliance with latest enterprise Cybersecurity guidelines, and provide input to site risk… more
- ManpowerGroup (Cambridge, MA)
- …completed and ensure alignment of GxP practices. + Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining ... in a pharmaceutical or related industry. + Experience in GMP Biopharma organization + Experience with SAP, Deviation systems...across a wide range of industries and skills. Our expert family of brands -_ **_Manpower, Experis, Talent Solutions,… more
- Integra LifeSciences (Boston, MA)
- …support development and sustaining/remediation projects. + Ensure that all projects are in compliance with GMP , QSR, ISO or other applicable requirements. + ... audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert . + Authoring & coordinating efforts for the development and implementation… more
- Integra LifeSciences (Boston, MA)
- …to support development and sustaining/remediation projects. * Maintain all projects are in compliance with GMP , QSR, ISO or other applicable requirements. * ... audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert . * Writing & coordinating efforts for the development and implementation of… more
- Merck (Boston, MA)
- …clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) + Demonstrates high capability to ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Procter & Gamble (Boston, MA)
- …+ Experience with a regulated industry, such as Food, Cosmetic, or Drug for knowledge of GMP compliance is a plus. + Role model electrical safety in ALL aspects ... issues, eliminating defects, and building technical mastery. They are a subject-matter expert in a specific technology, and they are capable of covering multiple… more
- Bristol Myers Squibb (Devens, MA)
- …drawings and review of TOP. Provides technical expertise as Subject Matter Expert for assigned equipment ensuring continued compliance to regulatory, company ... with the manufacturing operations of large scale production facilities as well as GMP experience. + Candidates must be effective in both a team environment and… more
- Danaher Corporation (Marlborough, MA)
- …role, you will have the opportunity to: + Act as a subject matter expert in one or more of the following Quality Management System elements: Change Management/Change ... our Quality System + Lead or support quality and compliance projects as requested, and perform other assigned duties,...At least 8 years relevant experience industry experience (eg GMP medical device, pharmaceutical) required + At least 5… more
- Kelly Services (Beverly, MA)
- …Job duties include: + Conducting microbial culturing and quantification experiments in compliance with GMP standards. + Performing small process scale filtration ... companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we… more