- Catalent (St. Petersburg, FL)
- …Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the ... QA Product Manager Position SummaryThe QA ...QA Product Manager Position SummaryThe QA Product ...all technical documents including but not limited to: a) change controls and associated Master documents, including but not… more
- Catalent (St. Petersburg, FL)
- Manager , QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations,… more
- Merck & Co. (Rahway, NJ)
- …Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development, and Clinical Supply across all modalities. We are ... their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our...more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is… more
- Aequor (Thousand Oaks, CA)
- Remote: 8-5 Minimum 3 years of experience. Digital Product Management and Planisware experience is a required. Nice to have: SAFe agile framework, previous business ... under the umbrella of a new digital platform ecosystem. Work with product owners and software developers to translate business requirements into technical features… more
- Aequor (Thousand Oaks, CA)
- …2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) ... Lead investigations) Lead plant audits, participate in site audits) Approve change -over completion) May perform work of QA Specialist EDUCATION/LICENSES Doctorate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pertain to training objectives for use at Senior Leadership meetings.Special Projects/ Change ManagementAssist the Director in the implementation of new processes, ... is required to keep informed of industry trends and newsworthy happenings, company product pipeline progress, and overall financial position of the Company in order… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data...complex points to a variety of stakeholders and drive change through persuasion but not organizational power required- 4… more
- Aequor (Thousand Oaks, CA)
- Manager is requesting candidates college GPA in the supplier notes of the resume if the candidate is willing to disclose. 8-5pm - Fully Onsite Experience: Open to a ... and/or AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …backup to the Manager for Data Stewards of Patient, Customer and Product masters. Role will also be responsible for day-to-day support activities related to ... Veeva Data Change Requests, field inquires on customer data related to...business rules. This position will also work with NNI Product Master. Role will ensure all Organization Manager… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position ... is responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that… more
- Novo Nordisk Inc. (Albuquerque, NM)
- …disease achieve greater health outcomes. If you are passionate about being a force for change , not afraid to take risks and challenge the status quo, and are looking ... local market and customer needs and positioning Novo Nordisks product and services to improve care of patients with...health. Internally, the OCS reports to the District Business Manager of the specific sales territory. The OCS also… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... Leader in driving strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Merck & Co. (Rahway, NJ)
- …Alliance Managers, and Governance Managers navigate Research & Development product development lifecycles, Research & Development pipeline governance processes, and ... include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and… 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,...for all Notified Body projects. Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated… more
- BioAgilytix (Durham, NC)
- …post-market product changes and decision on appropriate mechanism for change control (eg internal documentation, notification of change , supplemental ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Merck & Co. (Durham, NC)
- …equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Develops standard operating procedures (SOP's) ... for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... This role will support our QC teams under the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates with… more
- Aequor (Thousand Oaks, CA)
- 100% Remote. - manager prefers east coast. Candidate may need have to be flexible to account global hours. (Occasional meetings early mornings or later in the ... US Location or in Thousand Oaks, CA. reporting to Manager or Sr. Manager Supply Chain within...in a continuous improvement role applying tools, methodologies and change management (ie Lean, Six Sigma) Demonstrated experience leading… more
