- Merck & Co. (North Wales, PA)
- …issues through collaboration with the team and escalation to the DQR-(Device Quality and Regulatory ) leadership team as appropriate. Participation in early ... a Director, the Associate Principal Scientist is responsible for implementing regulatory strategies for our organization in accordance with domestic and… more
- Repligen (Waltham, MA)
- …Director, Global Regulatory Affairs will report directly to the VP, Global Quality .This role will be accountable for the Regulatory oversight of all Repligen ... support quarterly compliance auditsSupports CE testing and global environmental regulatory compliancePromotes a quality -oriented cultureThe ability to support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Legend Biotech.Lead and direct qualification activities to meet company goals, quality , and regulatory objectives. Qualification team will consist of ... the project engineering team and collaborate with other departments (Manufacturing, Quality , Regulatory , Development, Finance, and IT) on qualification… more
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... and investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- Formation Bio (New York, NY)
- … quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry ... pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA, EMA), industry standards (eg, cGMP), and company… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Formation Bio (New York, NY)
- …and manufacturing organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development ... and ensure timely resolution. Collaboration: Collaborate cross functionally with Manufacturing, Quality , and Regulatory colleagues to ensure seamless integration… more
- Tris Pharma (Monmouth Junction, NJ)
- …gather and interpret dataContributes to research protocol and amendment developmentSupports regulatory submissions by preparing high- quality documents meeting ... writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to ensure accuracy and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
- Aequor (Framingham, MA)
- …clearance, and leachable and extractables. Understand cGMP concept and familiar with quality and regulatory framework. Proficient in process data analytics ... Provide technical/scientific support, expertise, and guidance to manufacturing and quality . Ensure a solid understanding of engineering principles and theories… more
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... healthier world to live in.Job OverviewThe QC Supervisor focused on the Quality Control Laboratory, offering project and task management along with technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryAccountable for supporting and managing the Quality Management System (QMS) in accordance with regulatory requirements ... development of internal procedures to ensure compliance with global and harmonized Quality Standards and regulatory requirements for the GMP area.Additional… more
- Merck & Co. (Rahway, NJ)
- …technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory , Quality , and Supply Chain from early development through to ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... positions supports ensuring compliance with standard operating procedure and all regulatory requirements that may arise. This position is responsible for providing… more
- Merck & Co. (Durham, NC)
- …and process stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance, employee and ... for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …process qualification, packaging and labeling. This position will interface with Operations, Regulatory , Quality Assurance, Finance, R&D, Project Management and ... Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles, regulatory agency requirements and… more
- Merck & Co. (Rahway, NJ)
- …with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence ... of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs professionals, to achieve project goals.Key Attributes:Proven ability… more
- Aequor (Swiftwater, MN)
- …programs for appropriate audiences Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines. Assist with ... process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech's function also provides daily support, for manufacturing… more
- Tris Pharma (Monmouth Junction, NJ)
- …with clinical researchers, data managers and other stakeholders to ensure data quality and compliance with regulatory requirementsMentors and trains junior ... accuracy and integrity, contributing to research protocol development and supporting regulatory submissions. Provides expert statistical input in design and analysis… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... timely responses to business units' representative(s) and suppliers' inquiries.Assist with the development and implementation of standard operating procedures, work instructions and training materials.Support end to end supply chain activities and work… more
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