- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across...and that evidence is archived.Ensure up to date audit CAPA information in the eQMS in a timely manner.Support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as chair of PV ... Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred Excellent interpersonal skills and ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA information in the eQMS in a timely manner. Collaborate with QMS Team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) ( CAPA ) in connection with audit and/or inspection responses, and ensure ... proper implementation across various areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs Maintains current understanding of laws and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: Ability to travel up to 10% Business… more
- Aequor (Houston, TX)
- …of Supply Chain Quality Records (such as deviations, material recalls, and CAPA ) in partnership with applicable SMEs. Leads error prevention and continuous ... customer satisfaction within the scope of their role under guidance of supervisor/ manager o Generously shares information and knowledge with others across the team… more
- Cytiva (Pensacola, FL)
- …about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional leadership ... CFR requirements, and quality management practices, including operational controls, CAPA , complaints, audits, and risk management.Analytical and Process Optimization:… more
- Merck & Co. (Rahway, NJ)
- …reporting, investigations, and any related corrective action/preventive action ( CAPA ).- Facilitate equipment/system changes, execute periodic reviews and support ... Project management.-Track-record of independent problem-solvingSAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance (Gatekeeping and Work Order… more
- Caris Life Sciences (Phoenix, AZ)
- …**Position Summary** As part the Quality Assurance team at Caris Life Sciences, the Manager , CAPA & Complaints position provides quality oversight of the CAPA ... and timeliness along with the review and approval of CAPA changes and extension requests. + Responsible to for...and standards. + Apply Risk Management standards to all CAPA system and Complaints processes. + Work with other… more
- Cook Medical (Pittsburgh, PA)
- …by helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for ... overseeing all activities performed by the Investigations Writing team. The manager works closely with QA Management to ensure Investigations, CAPAs, and Complaints… more
- PCI Pharma Services (Philadelphia, PA)
- …systems processes including Deviations, Change Controls and Corrective and Preventative Actions ( CAPA ). The Manager will also drive initiatives to analyze ... to pioneer and shape the future of PCI. The **Quality Systems Manager ** is responsible for overseeing and maintaining the Electronic Quality Management System… more
- Fresenius Medical Center (Waltham, MA)
- **ADDENDUM:** **_GMS CAPA Office Focus_** + Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality ... Management and formerly used NC/ CAPA tools into one global electronic NC/ CAPA ... Review Board meetings. + May escalate issues to supervisor/ manager for resolution, as deemed necessary. + Mentor other… more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective Action and Preventive Action ( CAPA ) investigations as well as Non-Conformance (NC) ... NCs. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel… more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job Location Devens, MA Workspace On-site position (no remote or hybrid options) Target Hiring Date July 14, 2025 Work ... AND RESPONSIBILITIES: * Provide QA support to the Devens site and QA Manager by reviewing and approving investigations and corrective actions (CAPAs). * Make… more
- Medtronic (Mounds View, MN)
- …investigations, and coordinating marketing aspects of Corrective and Preventive Actions ( CAPA ). The Marketing Quality Program Manager ensures that commercial ... in the Life** The Sr. Principal Marketing Quality Program Manager serves as the critical link between the quality,...an action in progress. Your day may include a CAPA triage board call, where a product or system… more
- Danaher Corporation (Fargo, ND)
- …Quality Control Clinical team, report to the Quality Control Release Testing Manager , and be responsible for ownership of various technical writing and continuous ... improvement projects including deviation investigations, CAPAs, and change controls. In this role, you will have the opportunity to: + Lead and author deviation investigations including root cause analysis, trend investigation, and impact assessment + Manage… more
- Integra LifeSciences (Columbia, MD)
- …test method validations and monitoring procedures. + Change control, non-conformance and CAPA support. + Support the department manager with providing direction ... to the team, coordinating work flow, and providing guidance in the resolution of problems or areas of concern + Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. **DESIRED MINIMUM QUALIFICATIONS** The requirements… more
- Actalent (Lawndale, CA)
- Job Title: Quality Manager Job Description We are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance ... audits, including FDA inspections and ISO certification audits. + Oversee CAPA , nonconformance, and complaint handling processes. + Collaborate with cross-functional… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- **Job Description Summary** Sr Design Quality Systems Manager reports to the Director, Quality Management, WWIPD. The Sr Design Quality Systems Manager is ... trends, and prepare Management Review meetings. + Maintain effectiveness of the CAPA process. + Ensure effective and consistent application of design controls across… more
- Jabil (West Chester, PA)
- …you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory Compliance Manager to work in West Chester, PA. As the Regulatory Compliance ... Manager , you will manage all Regulatory Compliance Activities at...site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners,… more
