- Amgen (Holly Springs, NC)
- …in new facility start-up or tech transfer projects + Expertise in global regulatory requirements ( FDA , EMA, etc.) + Strong background in laboratory compliance, ... companies, is investing $550 million to build a new multi- product drug substance bio manufacturing facility in Holly Springs,...space. Amgen is targeting 2024 for site completion. Senior Manager Quality Control Support **What you will do** Let's… more
- Novant Health (Charlotte, NC)
- … regulatory entities including FACT, CLIA, NMDP, CIBMTR, and FDA . Responsible for qualification, validation, auditing of all critical processes,equipment, ... Job Summary The Cell Processing Lab Manager is an integral leader within our growing...maintenance of critical documents such as SOPs, forms,worksheets, and product labels. Approves technical lab processes and procedures. Manages… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …annual product reviews. + Participates for direct interaction with regulatory and internal inspections/audits including presenting site EM test and trending ... guidance as well as consults with manufacturing and internal regulatory departments on GXP matters. + Uses expertise and...results to production business units to be used for product related decisions. + Serves as SME regarding environmental… more
- West Pharmaceutical Services (Kinston, NC)
- Operations Manager Requisition ID: 70918 Date: Jul 31, 2025 Location: Kinston, North Carolina, US Department: Operations Description: At West, we're a dedicated team ... manufacturing experience preferred + Experience working with ISO standards, FDA and cGMP required + Pharmaceutical manufacturing experience preferred +… more
- ITW (Washington, NC)
- …This position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated with the ... to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including… more
- J&J Family of Companies (Wilson, NC)
- …efforts. + Serves as Subject Matter Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of ... projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and...in a multi-cultural and matrixed environment. + Knowledge of FDA /EMEA regulatory requirements related to biologics and/or… more
- Merck (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... be used to produce the bulk active ingredient, finished product , and laboratory testing for the BCG vaccine. The...a team environment **Preferred:** + Experience with responding to regulatory questions with multiple agencies ( FDA , EMA,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. ... to the Stability and Quality Control departments. + Represent Glenmark as appropriate in FDA , notified body, internal and other regulatory audits. + Work in… more
- ThermoFisher Scientific (Greenville, NC)
- …Position will support to the Greenville, NC, site and will report to the Sr Manager , Validation. The Drug Product Division - North America (DPD-NA) is one of ... for negotiating with clients on agreements/projects and resolving significant validation, product , and regulatory issues. + Evaluate new regulations, changes… more
- Medtronic (Charlotte, NC)
- …used in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with ... part of the RAS service team, will be responsible for providing product technical troubleshooting for Global field technical escalations, spare parts provisioning,… more