- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... (Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic ... and performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all… more
- Aequor (Athens, GA)
- …and Global Supply facilities, having direct impact on site performance including EHS, regulatory compliance , quality , future innovation timelines, and animal ... used in clean utilities. Ensure all maintenance activities comply with regulatory standards and safety protocols, including cleanliness of assigned facilities and… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Twist BioScience (South San Francisco, CA)
- …labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements ... The Regulatory Operations Specialist is responsible for ensuring the...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (Durham, NC)
- … Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities to ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Merck & Co. (Rahway, NJ)
- …Metrology, Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing ... Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories Division is… more
- Aequor (Thousand Oaks, CA)
- …on new technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management ... and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc. Determine key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Aequor (Thousand Oaks, CA)
- …and adaptable to changing priorities and requirements? Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance ? ... and laboratory logbooks. Preferred Qualifications ? Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures ... database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an… more
- Pall (Miami, FL)
- … related field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- Aequor (Swiftwater, MN)
- …This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... Quality and Raw Materials. This position requires proficiency and...Validation, Independent Demand, and Stability program. Maintain safety and compliance of the laboratory work area. Perform cleaning of… more
- Michael Page (Skokie, IL)
- …through science, innovation, and integrity. Renowned for their steadfast commitment to quality , regulatory compliance , and consumer trust, they create ... and health claims to ensure compliance with legal and regulatory requirements. Cross-Functional Collaboration: Partner with R&D, Quality Assurance, Product… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance .Excels in technical writing, able to… more
