- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key Responsibilities Oversee cell therapy production and ensure safe and ... compliant manufacturing operations according to cGMP requirements.Lead a ~250+ organization responsible for either the...have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and… more
- Merck & Co. (Rahway, NJ)
- …for clinical supply manufacture and/or regulatory inspections. Independently performs audits of batch documentation, data, information, procedures, equipment and ... approve GMP documents. Ensure all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch… 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
- 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
- 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
- DuPont (Hemlock, MI)
- …healthcare market quality requirements (including Current Good Manufacturing Practice [ cGMP ] standards). This person will provide leadership while maintaining ... quality certifications, quality-related aspects of supplier relationships, training, quality audits , and Corrective and Preventive Action [CAPA] initiatives. This… more
- WuXi AppTec (Middletown, DE)
- …highly experienced and detail-oriented **CQV (Commissioning, Qualification, and Validation) Manager ** to lead the execution of commissioning qualification, and ... validation activities at our pharmaceutical manufacturing facility. The CQV Manager is responsible for ensuring all equipment, computerized systems, facilities, and… more
- PCI Pharma Services (Philadelphia, PA)
- …network to pioneer and shape the future of PCI. The Sr. Operations Manager is responsible for the safety, quality, and operational excellence for Advanced Drug ... along with all federal, state and local regulations, including OSHA, FDA, cGMP standards and employment law + Demonstrate substantial knowledge of the pharmaceutical… 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
- Kedplasma (Houston, TX)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... corrective action(s) as needed. . Responsible, in collaboration with the Center Manager , for overseeing all activities related to product quality, and ensuring… more
- ThermoFisher Scientific (Plainville, MA)
- …validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance, ... rare, and otherwise untreatable diseases. **Discover Impactful Work:** The Manager , Quality Control Bioanalytical & Analytical Transfer provides leadership and… more
- BioLife Plasma Services (Latham, NY)
- …manufacturing is performed consistently according to current Good Manufacturing Practices ( cGMP ), the Shire Quality System, and other applicable regulations for a ... must also maintain complete and accurate records, in accordance with cGMP . ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local… more
- Actalent (Orlando, FL)
- Description Ensure facility compliance with cGMP regulations (21 CFR Part 111 for dietary supplements, 21 CFR 210/211 for OTC drugs if applicable, and ISO 22716 for ... instructions, and quality manuals. Manage regulatory inspections (FDA, state, third-party audits ) and coordinate responses to findings. Stay updated on relevant… more
- Actalent (Orlando, FL)
- Job Title: Quality Operations ManagerJob Description As a Quality Operations Manager , you will ensure facility compliance with cGMP regulations, oversee the ... regulatory compliance across all operations. Responsibilities + Ensure facility compliance with cGMP regulations for dietary supplements, OTC drugs, and skin care. +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Manager provides Quality support and oversight ... RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Manager , QA for QC is responsible for quality oversight of the Quality Control… more
- Biomat USA, Inc. (Worcester, MA)
- …and services in more than 110 countries and regions. **Quality Systems Manager (QSM)** **PRIMARY RESPONSIBILITIES** : . Evaluates processes, develops action plans, ... staff competency in their assigned job duties. Maintains and audits training records and files. . Collaborates with Center... training records and files. . Collaborates with Center Manager to ensure the donor center operates in a… more
- Biomat USA, Inc. (Pocatello, ID)
- …and trust, then consider furthering your career with us as a **QUALITY SYSTEMS MANAGER ** ! Please read on **JOB TITLE:** QUALITY SYSTEMS MANAGER **Summary:** ... as required. + Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation… more
- PCI Pharma Services (Rockford, IL)
- …Quality Specialist(s) and Quality Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality product, on time. Drives ... on-boarding of new employees to the team. + Provide support for customer audits , visits, and conference calls. Work with Clinical Customer Focused Team to develop… more
