- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP , FDA, as well as all applicable company compliance guidelines,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).Responsible to maintain permanent inspection readiness and actively… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience and judgment to plan and accomplish… more
- Novo Nordisk Inc. (Durham, NC)
- …for projects according to science & risk-based validation (SRV). Relationships Manager , Process Support - OFP. Essential Functions Participate & provide feedback ... Track & assess effectiveness of corrective / preventative actions from audits , inspections & investigations Participate in continuous improvement initiatives using… 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 ... applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP , USP, and CDR rules, and guidelines), and ensure...for assigned areas and participate in internal and external audits as SME for department and respond to audit… more
- Merck & Co. (Durham, NC)
- …suite teams, as required.Other: Direct support of regulatory inspections and audits .Direct support of validation activities and all other associated Quality ... collaboration with peers.-Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided by policies and procedures that impact… more
- Merck & Co. (Durham, NC)
- …Ensure individually assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. Provide QA shop floor ... to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review of… more
- Honeywell (Baton Rouge, LA)
- …quality documents; prepares all corresponding documents and reports + Leads all external cGMP audits of vendors, including US and International cGMP , ... The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP ...audits , as needed + Coordinates annual and ongoing cGMP training + Acts as a primary contact for… more
- Houston Methodist (Houston, TX)
- …daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies. + ... as necessary **SERVICE ESSENTIAL FUNCTIONS** + Participates in internal audits and external inspections by Regulatory Agencies and reports...Assists Quality Assurance Manager , cGMP Core Director and/or team members… more
- Element Materials Technology (Ann Arbor, MI)
- **Overview** Element Ann Arbor has an opportunity for a **Department Manager ( cGMP Testing)** to join our growing team in Michigan. In this role you will be a ... of conduct, and company policies and procedures. The **Department Manager ( cGMP Testing)** will provide leadership to...to mitigate risks and uphold quality. + Conduct internal audits to ensure cGMP compliance, maintaining a… more
- Berry Global (Ahoskie, NC)
- …training of employees on defect recognition and cGMP . + Participate in customer audits . + Manager vendor complaint program. + Performs internal audits . + ... events, and develops plant wide quality systems. + Back up Quality Manager , Quality Engineer, and Document control coordinator, as required. + Accepts responsibility… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Aseptic Operations Manager Department: Operations Plant Head Location: Monroe, NC START YOUR APPLICATION ... exceedingly well prepared to take the completion head-on. The Aseptic Manufacturing Manager is responsible for leading a team of production supervisors, team leads… more
- Fujifilm (College Station, TX)
- …**_Summary:_** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an **eQMS Manager ** to lead the configuration, implementation, analysis, and maintenance of ... Quality Management Systems (eQMS)** . This role ensures compliance with ** cGMP , and regulatory requirements** while optimizing eQMS functionality and efficiency. The… more
- Curia (Albuquerque, NM)
- Manager , Microbiology in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... matching contributions + Learning platform + And more! Summary The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology… more
- Sanofi Group (Ridgefield, NJ)
- **Job Title:** Manager , Quality Control **Location:** Ridgefield, NJ **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... infectious diseases and bring hope to patients and their families. **The Manager Quality Control** is responsible for technical management of personnel involved in… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with a variety of dosage forms. * Working experience conducting and/or hosting cGMP audits . * Certification from the American Society for Quality (ASQ) ... include managing and conducting activities related to current Good Manufacturing Practice ( cGMP ) site audits , quality control and manufacturing (QCM) product… more
- ADM (Kennesaw, GA)
- …with the Quality Manager to lead all ISO 17025 and regulatory audits related to the laboratory operation + Submit performance improvement initiatives and drive ... **95334BR** **Job Title:** QC Lab Manager - Kennesaw, GA **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job Description:**… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary The Manager , Microbiological Control is responsible for supervising the laboratory staff ... Ensure laboratory inspection readiness and provide support for regulatory inspections and audits . + Ensure timely completion of periodic review of procedures and… more
- Novo Nordisk (Bloomington, IN)
- …in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, ... in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank… more
- Novo Nordisk (Bloomington, IN)
- …disposition. Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support ... contact for key customers + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records,… more
