- Bristol Myers Squibb (Devens, MA)
- …with cross functional teams. + Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also ... This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This… more
- Integra LifeSciences (Braintree, MA)
- …possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance the ... matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate...software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product ... meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards,… more
- Takeda Pharmaceuticals (Boston, MA)
- …monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ ... continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the CPMQ team… more
- Cardinal Health (Boston, MA)
- …- Classification will collaborate with multiple teams and departments to ensure compliance and optimize trade operations. Cross training will be required to provide ... and special program eligibility assessments, including documentation review and compliance verification. + Collaborate with sourcing, procurement, engineering, and… more
- Bristol Myers Squibb (Devens, MA)
- …and Good Documentation Practices. + Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how ... on technology improvements and efficiencies opportunities to improve business and compliance . + Providing on-call support, as needed, for 24/7 commercial operations.… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... about pharmacovigilance! You are a team player who loves quality, compliance , finding solutions and ensuring training standards are implemented and successful.… more
- Beth Israel Lahey Health (Boston, MA)
- …a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). ... deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when issues are identified. (essential) +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ... amazing partners, including other Harvard Medical School-affiliated hospitals. **Regulatory Compliance ** + Prepares and submits all protocol applications, amendments,… more
- IQVIA (Boston, MA)
- …destination platforms and provide offline & online matches. + Responsible for full compliance and adherence to FDA Pharma Guidelines (where applicable). + Work ... with Sales and Operational teams to identify and develop upsell and "solution sales" opportunities. + Advocate customer needs/issues across Product and Technology teams. + Work with Product Management team to define new and existing product and reporting… more