- Repligen (Waltham, MA)
- …desirable.Experience:A minimum of 10 years of progressive experience in internal controls, SOX compliance , or related regulatory compliance roles within a ... OverviewRepligen Corporation is seeking a dynamic Controls & SOX Compliance leader. This is a high-impact, strategic role driving...strategy across a global company Lead SOX risk assessments, audits , and remediation efforts Partner with senior … more
- Merck & Co. (Rahway, NJ)
- …10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Audits Compliance , Audits ... Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Problem Solving, Process Improvements,… more
- Merck & Co. (Rahway, NJ)
- …10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Audits Compliance , Audits ... Trade Finance, International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management,… more
- Merck & Co. (Millsboro, DE)
- …environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote best ... Job DescriptionSr. Specialist, Biosafety The Sr . Specialist of Biosafety is accountable for providing and managing an efficient and effective Biosafety program at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, communicated and that audit targets for MA audits ... Safety and PharmacovigilanceR&DVendors/ CROs/ third partiesHEOR/ RWEEpidemiology Legal and compliance Marketing/ commercialGMP QA/ Supply chain / Regulatory … more
- Merck & Co. (Durham, NC)
- …querying), DeltaV SIS Experience working with Information Technology teams. Experience with regulatory audits and working knowledge of data integrity principles. ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations related to computerized systems, including GxP (GCP/GVL/GCLP/GLP).Collaborate with the Audits Compliance (RDPVMA) team to determine relevant audit ... for validation and qualification of IT services.In collaboration with Audits Compliance team, determine relevant audit targets...to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and… more
- Eisai, Inc (NJ)
- …activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. ... your profile, we want to hear from you. The Sr . Manager is to lead collaboration efforts with RandD...and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... excellence.Oversee global project budgets to ensure cost-effective solutions that meet compliance and technical standards; drive vendor assessments, audits , and… more
- Novo Nordisk Inc. (Durham, NC)
- …standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory & compliance ... also be responsible for the production activities & validation. Ensuring relevant compliance issues are addressed & handled in close collaboration with production.… more
- Aequor (Thousand Oaks, CA)
- …Maintain list of expected terms in the auto label tool Monitor the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ... and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Knowledge and skills: Knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A Bachelor's degree and a minimum of twelve (12) years pharmaceutical, legal, regulatory , or compliance experience OR an advanced degree with a minimum ... Nordisk's global monitoring and auditing program Supports global E&C audits of NNI, partnering with global auditors and NNI...of 10 years pharmaceutical, legal regulatory or compliance experience is required Technology… more
- Commonwealth Care Alliance (Boston, MA)
- …Reporting to the Director, Claims Operations & Quality Assurance, the Regulatory Compliance & Audits Sr . Specialist II is responsible for ensuring ... is critical to supporting CCA's internal handling of all regulatory audits and maintaining alignment with evolving...does not have direct reports. Essential Duties & Responsibilities: Regulatory Compliance & Monitoring * Monitor CMS… more
- US Tech Solutions (New York, NY)
- …of both technical and non-technical members. + Experience with designing and operationalizing regulatory compliance and audits for new and emerging ... eg, Risk and control matrix, policies, etc + Lead regulatory audits conducted by third party external...application security testing + Experience with designing and operationalizing regulatory compliance programs for new and emerging… more
- Banner Health (CO)
- …the best care for our Sophia's. Responsibilities include interpreting and implementing regulatory requirements, conducting compliance audits , and ensuring we ... health care advancements and excellent patient care. As a Regulatory Senior Systems Specialist, you will play...to all applicable regulations and standards within Facility Operations. Regulatory compliance is not just a requirement;… more
- The Cigna Group (Bloomfield, CT)
- …such as CISA, CIA, CISM, or CISSP preferred + Expertise in executing or managing regulatory compliance audits such as SOC1, SOC2 and SOX + Experience ... Compliance and Delivery Manager** This is a senior , individual contributor role **Job Description:** This is a...and respond to internal and external data requests for regulatory audits + Advise management on control… more
- Globus Medical, Inc. (Audubon, PA)
- …+ Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events + Regulatory Compliance & Audits : + Ensure CAPA and complaint processes align with ... improvement of quality-related issues related to customer complaints and regulatory compliance . This role ensures that CAPA...regulations + Serve as SME (Subject Matter Expert) during regulatory audits and inspections + Maintain compliant… more
- Medical Mutual of Ohio (OH)
- …health plan clinical operations which includes work in government programs (Medicare) compliance , regulatory audits and process improvement. **Professional ... improve quality, and enhance MA member satisfaction. Represents Clinical Operations in audits and committees and in MA Compliance activities. . Performs… more
- Molina Healthcare (Roswell, NM)
- …audits and mitigate findings. + Manage documentation (eg, requesting, reviewing, preparing) for regulatory and compliance audits & assessments. + Ensure ... Management programs, concentrating on internal and third-party risk assessments and audits . Assessment and compliance activities include validating controls in… more
- MongoDB (Palo Alto, CA)
- …organization's compliance program, ensuring alignment with industry standards and regulatory requirements + Lead compliance audits and investigations, ... laws, regulations, and industry standards + Lead and manage compliance audits and investigations, including preparing detailed...+ A minimum of 10 years of experience in compliance , legal, or regulatory roles + Strong… more
