- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory ... regulatory requirements as appropriate through customer complaints, internal audits and training systemsConduct trainings and/or communicate appropriate materials,… more
- Aequor (TX)
- …4 Years of experience minimum (pure medical devise) Support the NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory ... Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the...and Alcon QMS in coordination and execution of NB audits . Collaborate with the MDR PMs, GRA strategists and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …checks. Support lessons learned information flow based on read outs from audits , inspections, Quality Events, regulatory intelligence, effectiveness checks on ... checks. Support lessons learned information flow based on read outs from audits , inspections, Quality Events, regulatory intelligence, effectiveness checks on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data… more
- Merck & Co. (Durham, NC)
- …any team related compliance discrepancies noted during day-to-day activities and/or audits . -Escalate as per IPT management processes.Ensure 100% PM compliance per ... maintenance schedule within team.Participate in internal and external audits and inspections. Continuous Improvement: Provide a leadership presence on the… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations of ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Catalent (St. Petersburg, FL)
- …technical transfers and routine production.Provide support to internal, client, and regulatory audits .Engage in monitoring quality systems to maintain awareness ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and… more
- Tris Pharma (Monmouth Junction, NJ)
- …but not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits , as needed; Performs and/or ... New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...participates in internal and external audits , as neededManages, coaches and mentors direct reportsAny other… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... Quality Assurance activities that support VMF, including periodic shop floor audits , direct in-line Quality support for all compliance and environmental monitoring… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits , Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …plus Strong knowledge of cell therapy process preferred Experience in cGMP regulatory body audits Strong interpersonal and written/oral communication skills ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in...in Raritan, NJ. Role Overview The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities… more
- Merck & Co. (Rahway, NJ)
- …issues related to protocol conduct,-recruitment, retention, protocol deviations, regulatory documentation, site audits /inspections-and overall site ... assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead ... and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues Performs vendor audits as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …facility, and deviation issues Assists in performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job ... QA presence on the manufacturing floor. Essential Functions Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and...for assigned areas and participate in internal and external audits as SME for department and respond to audit… more
- Novo Nordisk Inc. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & ... Standards "Gatekeeper". Relationships Senior Project Manager - OFP. Essential Functions Support plans to maintain & improve process control systems Schedule &… more
- Sodexo (Little Rock, AR)
- …opportunities and a rewarding environment.** Sodexo has a new opening for **a Senior Manager , HSE Food Manufacturing Audits ** to join our team. This position ... should reside in the Central Time Zone. The **Senior Manager , HSE Food Manufacturing Audits ** will conduct...audits to ensure food safety, quality, sanitation, and regulatory requirements of internal and external suppliers are meeting… more
- Capital One (Melville, NY)
- …dispositioning findings identified by compliance testing + Supporting manager on regulatory exams and/or internal audits , as necessary + Maintaining expert ... 1307 Walt Whitman (22600), United States of America, Melville, New York Compliance Manager - Lending & Finance Corporate Compliance is seeking a Compliance Advisor … more
- Randstad US (Morton Grove, IL)
- …on the execution of the cleaning and sanitation SOP's + Supports the Sr. Quality Manager during external and regulatory audits . + Leads the activities ... able to support the facility during internal and external audits . Position requires ability to problem solve, work on...of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Fareva SOPs. + In addition… more
- Abbott (Plano, TX)
- …Our Plano or Austin, Texas locations, currently have an on-site opportunity for a ** Regulatory Affairs Manager ** . This position leads project submissions for ... with regulatory strategy and business objectives. + Assist with audits and inspections, as needed. **Required Qualifications** + Bachelor's Degree OR an… more
