- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. -Under ... direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Business Partner is responsible for regularly evaluating external compliance trends, internal business strategies, monitoring, auditing, investigations data, and ... time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve as a knowledgeable and effective… more
- Merck & Co. (Durham, NC)
- …metrics and production needs. Serve as the Microbiology subject matter expert for internal and regulatory inspections. Participate in routine audits of Quality ... regulatory requirementsProvides active support during audits and inspections ( regulatory , internal , safety)Supports our Manufacturing Division divisional and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QMS, PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered ... (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the internal and external study teams. This may include participation in internal and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and efficient conformance to all quality expectations and compliance with all regulatory standards. This position is the decision maker for the Quality Management ... through risk monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality Director will represent… more
- Merck & Co. (Rahway, NJ)
- …will have a strong scientific background and will collaborate with both internal and external teams to ensure the successful commercialization of our innovative ... The incumbent will be expected to interact closely with internal development partners and with internal and...The individual will have a deep understanding of the regulatory and business environment and needs related to API… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely ... environment. This role will be responsible for managing multiple vendor relationships, internal and external auditors and payroll and tax providers. The individual… more
- Merck & Co. (Rahway, NJ)
- …and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.Perform investigations with strong technical ... troubleshooting skills.Provide documentation/technical input during inspections and audits ( Regulatory and Internal ) and have a working knowledge of data… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering continuous improvement are the key objectives. ... and implementing efficient and effective means of communicating with both internal and external constituents, and executing those activities, initiatives, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Sterility Assurance and Quality management during routine audits by regulatory agencies, pharma manufacturing partners and internal corporate ... auditors.Assist as a facility sterility assurance SME on product development and commercialization of new productsExperience RequirementsMicrobiology background, ideally within a sterile manufacturing site with more than one sterile production line.Two (2) or… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of ... technology developmentExperience with risk assessments, process characterization, validation, and regulatory authoring.Proven track record of technical innovation and sharing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee production metrics. This individual will support manufacturing investigations , support and manage change controls, and maintain permanent inspection ... readiness and actively support regulatory inspections. This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure… more
- Meta (Menlo Park, CA)
- …and implement strategy for managing and resolving regulatory inquiries and investigations 2. Conduct detailed internal investigations in connection with ... As part of the role, they will partner with internal stakeholders from across the company to mitigate risk.The... regulatory inquiries and investigations , including leading fact development and coordinating with teams… more
- Amgen (Holly Springs, NC)
- …of all findings. + Drive improvements to the investigation process. + Present investigations to regulatory inspectors, internal auditors, and management. + ... + Demonstrated project management ability + Experience presenting to inspectors during regulatory inspections and internal audits. + Excellent written and verbal… more
- Charles Schwab (Westlake, TX)
- …+ You have significant experience supporting and preparing for complex litigations, internal investigations , regulatory inquiries, and corporate governance ... production, and preservation of data and documents across litigations, arbitrations, investigations , regulatory matters, and corporate governance filings. +… more
- LS Power Development, LLC (Chesterfield, MO)
- …submission of compliance reporting obligations. + Provide support with internal investigations , audits and responses to regulatory requests from federal and ... paid premium healthcare, paid parental leave and more. **About the Role:** The Regulatory Compliance Analyst is responsible for providing regulatory support and… more
- Deloitte (Sacramento, CA)
- …under investigation or in litigation and helping clients manage and respond to internal and external investigations , regulatory concerns, litigation, and ... financial accounting and reporting issues enabled by digital technologies. + Regulatory & Forensic Investigations : Assisting with compiling, analyzing, and… more
- Deloitte (Rosslyn, VA)
- …under investigation or in litigation and helping clients manage and respond to internal and external investigations , regulatory concerns, litigation, and ... financial accounting and reporting issues enabled by digital technologies. + Regulatory & Forensic Investigations : Assisting with compiling, analyzing, and… more
- Citigroup (Irving, TX)
- …including electronically stored information, required for internal or external investigations , litigation, or regulatory actions + Responsible for managing ... issuers, underwriters, investment advisors, officers, and directors in anti-trust litigation, regulatory investigations , and class actions brought by or against… more
- Amazon (San Diego, CA)
- Description The Regulatory Intelligence, Safety and Compliance (RISC) team's charter is to protect Amazon customers from products that are illegal, illegally ... risk/loss prevention, or equivalent - Experience establishing successful partnerships with internal and external teams to execute tactical initiatives or equivalent… more
