- Aequor (MA)
- …timely initiation of GMP manufacturing activities. Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, ... BOM approval. Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be...of relevant experience Minimum 5 years of experience in Quality Working knowledge and ability to apply Quality… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... Global Incoming Quality Process Operations to support Global Process Owner lead . Interface with IQA Network, various sites and business partners to ensure… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records ... with specifications and procedures Releases product based on Quality Assurance record review and approval by...Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality… more
- Eisai, Inc (Nutley, NJ)
- …the development of global standards and processes for supplier security assessments. Compliance Adherence and Assurance : Coordinate, participate and drive ... Additional Certified Information Systems Auditor certification is advantageous.ISO 27001:2013 Lead Implementer / Auditor certification.Practical experience managing compliance… more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data...primary responsibilities of this position include but not limited to: Lead efforts to design, build, and maintain data pipeline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliance of all required DS documentation for quality control/ assurance , legal, finance, operational and educational requirements.Operates at ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...compliance and alignment with DS highest standards. Uses quality improvement techniques to increase the quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... quality indicating data and identifying trendsProvide oversight for trending of quality compliance metricsWork in a collaborative team setting with … more
- Merck & Co. (Rahway, NJ)
- …will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including ... goals and metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance ...development processes (Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product validation, verification,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... efforts, site escalations, and quality projects.Key Responsibilities Provide quality and compliance input for identified continuous improvement efforts… more
- Merck & Co. (Upper Gwynedd, PA)
- …effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical ... quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality … more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... Support and lead continuous improvement projects.Managing people to support Quality improvement initiatives.Provide quality and compliance input for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision...in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research… more
- BioAgilytix (Durham, NC)
- …a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementTrack project ... a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementPrepare Sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... and coach cross functional team staff in areas such as quality , compliance , safety, project planning, process development, technology development.Communicate… more
- Aequor (Louisville, KY)
- …absence of a Life Sciences degree, 4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing ... Candidate: Bachelors &plus 2 years of working experience. Labatory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma ... compliance .Must have a strong knowledge and experience with cGMP, GCP, GLP, Quality and Compliance .Must have strong authorship and be able to critically… more
- BioAgilytix (Durham, NC)
- …budget.Workstream Coordination: Manage all internal BioAgilytix teams (lab operations, IT, quality assurance ) and external resources to ensure efficient project ... planning to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite… more
