- Endo International (Raleigh, NC)
- …is the primary point of contact for the testing of all raw materials, in- process , finished goods, and stability samples. She/he manages the Quality Control group and ... with GMP and regulatory guidelines.** + **Oversee analysis of raw materials, in- process samples, and finished products to ensure they meet specifications.** +… more
- GRAIL (Durham, NC)
- …For more information, please visit grail.com . Reporting to the Senior Director , Quality Strategy & Operational Excellence, the Senior Quality Engineer is ... and coordinate the CAPA program, NCR program, quality metrics, and quality planning process . + Maintain and improve these programs in compliance with GRAIL's Quality… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing ... collaboration to drive continuous improvement and adherence to regulatory standards. The Director , Process Validation is crucial in enhancing the site's … more
- Lilly (Raleigh, NC)
- …expectations and business objectives. **The Senior Advisor/ Director , MSAT Global Process Owner for Sterilization Validation QMS is responsible for these ... Assurance function and capability to provide increased technical sterilization validation capacity across the network. **Position Brand Description:** + The… more
- Fujifilm (Holly Springs, NC)
- …to ensure full CGMP compliance by operations launch * Ensures the integration of process validation (PV), CV, and computerized system validation (CSV) into ... **Position Overview** The Associate Director , Cleaning Validation is responsible for...This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment… more
- Stantec (Raleigh, NC)
- …design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/ validation , you will work on a variety of ... reports to assist in closure of protocols. - Assist Director of Commissioning/ Validation with client presentations, client...At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable… more
- Lilly (Raleigh, NC)
- …provide increased technical capacity across the network. **Position Brand Description:** The Director /Senior Director , Global Process Owner for Sterility ... agency standards, industry trends and scientific principles. **Key Objectives/Deliverables** **The Director /Senior Director , Global Process Owner for… more
- Fujifilm (Holly Springs, NC)
- …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation… more
- United Therapeutics (Research Triangle Park, NC)
- …Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems + Continuous Process Validation experience + Knowledge of software validation ... and process development and improvement, implementation of product/ process verification, validation activities, and commercialization. Responsibilities for… more
- Lilly (Durham, NC)
- …formulation and filling in aseptic environment + Previous equipment qualification and process validation experience + Previous experience with deviation and ... North Carolina. The Technical Services / Manufacturing Science (TS/MS) Director is responsible to provide leadership to the TS/MS...and efficiency. + Oversee the manufacturing of RTP products process control and validation strategy. The scope… more
- United Therapeutics (Research Triangle Park, NC)
- …our GxP Systems, SAP, and Automation & Control teams. The Associate Director , Operational Technology will provide leadership and management of Operational Technology ... staff and ensure the ongoing development of the team. The Associate Director , Operational Technology will maintain a strategic approach to technology and automation… more
- United Therapeutics (Research Triangle Park, NC)
- …to "roll up your sleeves" and be hands-on whenever needed. The Senior Director of Quality Operations for Solid Dose leads site quality operations, including all ... manufacturing, packaging and distribution quality. This person drives lifecycle process quality in Manufacturing, Packaging, Distribution & CMOs, ensuring compliance… more
- Meta (Raleigh, NC)
- **Summary:** As the Mechanical & Controls Systems Engineering Director , you will lead, drive and execute on our strategy to engineer and design large-scale data ... connection and the technology that makes it possible. **Required Skills:** Director , Mechanical & Controls Systems Engineering Responsibilities: 1. Lead new data… more
- Amgen (Holly Springs, NC)
- …us and transform the lives of patients while transforming your career. **Associate Director Information Systems** **What you will do** Let's do this. Let's change ... and Business Practice. The Capital portfolio spans across multiple functions; Process Development, Manufacturing Clinical & Supply Chain, and Commercial areas and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more
- Ford Motor Company (Raleigh, NC)
- …way the world moves? **In this position ** We are seeking an Executive Director of Functional Safety to lead the development and implementation of functional safety ... regulatory and internal standards. + Establish and refine safety assessment and validation methodologies to improve early detection and mitigation of safety risks. +… more
- Eaton Corporation (Raleigh, NC)
- **Primary Function:** Eaton Corporation is seeking an Engineering Director , Digital Solutions, to lead a high-performing team dedicated to delivering simplified, ... strong project management processes around requirements gathering, software development & validation (scrum teams), testing and production support. + Manage the… more
- Sumitomo Pharma (Raleigh, NC)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the… more
- VTI Life Sciences (Raleigh, NC)
- …you - and deliver the world's most challenging Commissioning, Qualification, and Validation projects, together! Reports to Director of Operations, CQV. Direct ... (preferred but not required). They must have previous Engineering and/or Validation experience. The candidate will have some business development responsibilities… more
- Dispatch Health (Cary, NC)
- … process , arrange MATs (medical assessment tool) as needed, and complete Clinical Validation Process for all APP hires. + Evaluate New Grad Applicants and ... with the Market Manager (MM) and the Regional Medical Director and cross functionally with Central Services teams, to...for assigned area will be discussed during the interview process . **What You'll Do** **Recruitment/Hiring** + Build a highly… more
