- Merck & Co. (North Wales, PA)
- …AND BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission ... authoring, review and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in regularly scheduled call quality calibrations, provides feedback on quality assurance activities and case review Identify procedural deficiencies and ... Call Center Oversight is responsible for overseeing the initial evaluation of technical complaints for US Operations (USO) post-marketed products from all… more
- Merck & Co. (North Wales, PA)
- …lyophilization (freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and ... practical commercial manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of freeze-drying and fill-finish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, & Vendor ... Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor...Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance , Regulatory Affairs, etc.); advanced degree… more
- Security Risk Advisors (Philadelphia, PA)
- …Writing Sound Decision Making Analytical Thinking Workforce Scheduling Quality Assurance Data Reporting Strategic Planning Team Supervision Technical ... of services. Maintain communication between internal resources, escalating issues to Team Lead (s) when necessary. Liaise with account leads and internal team members… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …CFR 820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). + Demonstrated ability to lead QA medical device and combination products compliance and auditing ... related to medical device and combination products (FDA/ISO). + Lead Management Review meeting ensuring the Quality ...detail. + Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment.… more
- BeOne Medicines (Pennington, NJ)
- …to the MST leadership, this role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. ... Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support...Responsible for technical transfer, validation, investigation, and technical support of aseptic manufacturing operations in… more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job...or GXP with at least 8 years focused on product quality . Preferred Active member of ASQ or ISPE. + Prior ... and electronic, or paper-based batch records desirable. + Excellent Technical writing and oral communication skills are required. +...environment. About the Role DUTIES AND RESPONSIBILITIES: * Provide QA support to the Devens site and QA… more
- Genentech (Philadelphia, PA)
- …where we all have more time with the people we love. That's what makes us Roche. The QA Technical Operations Lead - Philadelphia, is part of the Pharma ... mission. **The Opportunity:** As an integral part of the QA Technical Operations team your...Operations team your main focus will be providing Quality Assurance oversight for the implementation and… more
- American Water (Camden, NJ)
- …Implement steps required to improve the processes * Be an advocate of Quality Assurance , continuous improvement and industry recognized Best Practices * Define ... applications * Own testing strategy, tools and techniques * Lead extended team of QA resources including...and implemented correctly * Experience in running strictly defined quality assurance processes. Test plans definitions and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …site. The Associate Director, QA is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations ... to business demands. The **Associate Director, Quality Assurance ** is responsible for directing the QA ...site management on a regularly scheduled basis + Provide QA Technical recommendations based on trend analysis… more
- Coinbase (Trenton, NJ)
- …Attendance is expected and fully supported. You will be a part of the Compliance Operations Quality Assurance team, which is responsible for conducting ... Quality Assurance audits on transaction monitoring system (TMS) cases, working...2LoD reviews and provide timely responses to findings * Lead calibrations & office hours supporting other QA… more
- Public Consulting Group (Trenton, NJ)
- …**Duties and Responsibilities** + Provides leadership, management, and direction to the Quality Assurance Analyst team. + Leads and manages department providing ... relevant technical discipline; Masters preferred + 7+ years relevant QA experience, 1 - 2 years supervisory/management experience **Working Conditions** + Office… more
- Merck (West Point, PA)
- …lyophilization (freeze‑drying) capacity being built at the site. This role is the Technical Lead for Lyophilization with both deep scientific experience and ... practical commercial manufacturing judgment. You will lead technical strategy, science‑based technology transfer and scale‑up of freeze‑drying and fill‑finish… more
- Meta (Trenton, NJ)
- …risk management and change management on projects. 5. provide day-to-day coordination and quality assurance for projects and tasks assigned. 6. Furthermore, they ... to Job" online on this web page. **Required Skills:** Technical Program Lead Responsibilities: 1. Manage cross-functional...17. 3. Working at scale and with 24x7 production operations 18. 4. Working with highly technical … more
- Public Consulting Group (Trenton, NJ)
- …Solutions + Project Assurance PCG is hiring a Senior Consultant to lead technical oversight on a public sector state government modernization project while ... providing a combination of the following services: Implementation, IV&V, project management, quality assurance ( QA ), and other project oversight services… more
- Deloitte (Philadelphia, PA)
- …a Martech Technical Architect at Deloitte Digital, you will serve as a technical lead and subject matter expert in both platform and custom development ... Work with offshore/nearshore Delivery Center resources, supporting front-end development oversight, quality assurance and skills development. + Act as marketing… more
- Merck (North Wales, PA)
- …BE ONSITE 3 DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission ... and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand...process questions and issues related to submission content management, quality and standards compliance + Engage across functional areas… more
- Deloitte (Princeton, NJ)
- …Planning: Lead sprint planning, backlog grooming, and retrospectives. + Quality Assurance : Oversee code reviews, automated testing, and CI/CD pipelines ... success. You'll work alongside talented professionals reimagining and reengineering operations and processes that are critical to businesses. Your contributions… more
- Penn Medicine (Philadelphia, PA)
- …is assigned to the individual, they will work with the Division's Quality Assurance manager in functioning as liaison to accrediting/regulatory agencies ... for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn Medicine,… more
