- Repligen (Waltham, MA)
- …Change Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... team. You will a key role in ensuring the quality , compliance , and performance of Repligen's global...root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is… more
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …not limited to: Lead and oversee analytical investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak ... chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and business improvements.Demonstrate the ability to influence meaningful… 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. (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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 (West Greenwich, RI)
- …as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines, ... cGMPs/CFRs and other applicable regulatory requirements. Shift: Saturday - Tuesday shift schedule. Skills: Previous lab experience is preferred.Basic Qualifications:… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to...as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders… more
