- 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 ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality ,… 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
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience working with drug-device ... Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management...Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of… more
- Merck & Co. (Rahway, NJ)
- …a critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy ... wallets.Proven track record in vendor management, strategic planning, and regulatory compliance .Strong analytical, negotiation, and project management… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... relevant processes. Ensures alignment of training processes to corporate & quality systems. Responsible for maintaining Standard Operational Procedures (SOPs) for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Merck & Co. (Durham, NC)
- …packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal ... Job DescriptionOur Quality group ensures every single material inside our...the shop floorConsults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …full alignment across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information ... Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Compass Group (Wichita, KS)
- …policies and procedures. Encourages and mentors staff creativity and innovation. Ensures compliance with all regulatory agencies and is proactive in the ... and talented individuals working in the industry today. Our dedication to quality , exceptional customer service, and unequivocal results allow us to provide the… more
- BioAgilytix (San Diego, CA)
- …and Formulation Chemistry departments. This role oversees daily laboratory operations, scientific quality , and regulatory compliance across both functions, ... and ongoing training for department staff.Develop and maintain SOPs in compliance with regulatory requirements.Drive innovation through evaluation and… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times, ... guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… more
- Merck & Co. (Durham, NC)
- …an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to ... guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Twist BioScience (South San Francisco, CA)
- …that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this ... by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll… more
