- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control , and compliance protocols.Define standards, ... integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks… more
- BioAgilytix (Durham, NC)
- …monitoring, and disaster recovery planning.Strengthen identity, access, and endpoint security controls across the enterprise.Drive data protection and privacy ... security and SaaS shared‑responsibility models; vendor RACI, audit rights, and data residency controls .Demonstrated BCDR delivery for mission‑critical workloads… more
- Merck & Co. (Millsboro, DE)
- …Technology Applications, Interpersonal Relationships, Management Process, Productivity Initiatives, Quality Control Management, Quality Improvement ... part in our operational excellence. Specifically, you would be the Site MPS Lead for the Millsboro site, responsible for collaborating on and managing the lean… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute to maintain investigation ... treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality ...Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA… more
- Merck & Co. (Rahway, NJ)
- …Industrial Hygiene, Innovation, Inventory Management, Management Process, Manufacturing Quality Control , People Management, Pharmaceutical Biology, ... degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth… more
- Merck & Co. (Rahway, NJ)
- …Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within ... business applications, laboratory instrument systems, manufacturing automation systems and data analysis packages.Endorse and build Quality Management System… more
- Aequor (Cincinnati, OH)
- …Like all Quality department professionals at , this position will lead initiatives which specifically protect our brands. This role will require high learning ... Job Title: Food - Quality Technician Location: Cincinnati, OH 45241 Duration: 03... notifications in SAP for defective materials or packaging Lead the plant sensory program, documentation, and gold standard… more
- Aequor (Davie, FL)
- Job Title: Automation Engineer - IT/OT & Controls Integration (Pharmaceutical)100% Onsite - Local candidates only.Shift: Monday - Friday 8:00am - 5:00pmTemp to Perm: ... with Master's Degree or Ph.D.2. Min 3 years experience with AI/OT/ controls experience within a GMP-regulated pharmaceutical or medical device environment.3. Min 3… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. Controls and assures the quality of the material content of any ... of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Merck & Co. (Durham, NC)
- …manufacturing facility.- Responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance ... or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and ... Data Management teams, MA stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout the clinical trial… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key ... packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …years of relevant work experience Strong background across manufacturing operations, technology, quality , and supply chain.- Proven ability to lead global, ... Small Molecule VCM Product Leader (PL) is the end-to-end (E2E) supply chain lead responsible for developing and executing product supply strategies for one or more… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing ... sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr. Manager, Strategic Initiatives to support various strategic… more
- Merck & Co. (Boston, MA)
- Job DescriptionWe are seeking an experienced Technical Product Manager to lead pharmaceutical process and meth od development data product portfolio. This unique ... Successful candidate will be accountable for timely availability of quality , reliable data to support insights needs...to learn and evolve the product. - Create and lead cross-functional teams comprised of data scientists,… more
- Capital One Bank (Riverwoods, IL)
- …function is a dedicated group of professionals focused on delivering top- quality assurance services to the organization's Audit Committee. Audit professionals are ... Services as part of our integration effort. Responsibilities include:Plan, perform, and lead large/complex audits at the enterprise level as well as other diverse… more
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems, Regulatory ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Capital One Bank (Fredericksburg, VA)
- …function is a dedicated group of professionals focused on delivering top- quality assurance services to the organization's Audit Committee. Audit professionals are ... Services as part of our integration effort. Responsibilities include:Plan, perform, and lead large/complex audits at the enterprise level as well as other diverse… more
- Merck & Co. (Rahway, NJ)
- …analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...(separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data … more
