- Sanofi Group (Framingham, MA)
- …Team + **Lead cGMP compliance projects** aligned with the company's Quality Operations strategy and US FDA regulations. + **Drive digital transformation ... **Job Title:** Compliance Head- US FDA **Location** :...**Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA… more
- ManpowerGroup (Westford, MA)
- …the Job?** + Initiate and oversee medical device quality assurance activities in compliance with FDA Quality System Regulation and ISO13485. + Develop ... a leader in the medical device industry, is seeking a Quality Engineer to join their team. As a Quality Engineer, you will be part of the Sustaining Quality… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Principal Compliance Specialist, Quality Assurance Operations **Location:** Framingham, MA **About the Job** We deliver 4.3 billion healthcare ... assuring the security of the company's business and global markets. The Principal Compliance Specialist is responsible for providing quality support and guidance… more
- Integra LifeSciences (Braintree, MA)
- …what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs ... matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate...of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016,… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of ... + Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the… more
- United Therapeutics (Boston, MA)
- …you're passionate about pharmacovigilance! You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more
- Wolters Kluwer (Waltham, MA)
- …the company. You will report to the VP, Clinical Content Management **RESPONSIBILITIES** ** Quality Management and Compliance ** + Maintain and monitor Quality ... (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused… more
- Charles River Laboratories (Wilmington, MA)
- …you can feel passionate about. **Job Summary** The Sr. Manager, Global Trade Compliance , will provide trade and Customs support to CRL's global business units. In ... will report directly to the Director of Global Trade Compliance and will oversee the day-to-day management of the...origin determination, and all participating government agency requirements (ie FDA , USDA/APHIS, FWS, CDC, EPA) * Oversee the Post… more
- Hologic (Marlborough, MA)
- …by the FDA , notified bodies, and other regulatory agencies. + Quality System Compliance : Ensure adherence to applicable regulatory standards, including ISO ... The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory...13485, FDA QMSR and other applicable requirements. + Review and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage ... Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to… more
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