- Merck & Co. (Rahway, NJ)
- …and/or approve GMP documents. Ensure all API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy ... clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key Responsibilities Oversee cell therapy production and ensure safe and… more
- Merck & Co. (Rahway, NJ)
- …Product/sterile experience. Required Experience and Skills :-Strong familiarity with Quality , cGMP , Safety & Environmental Policies and Procedures.Familiarity ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating ... internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract… more
- Houston Methodist (Houston, TX)
- …and prioritize daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in ... defining quality policies. + Assists Quality Assurance Manager , cGMP Core...of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations + Experience performing equipment validation… more
- WuXi AppTec (Middletown, DE)
- …seeking a highly experienced and detail-oriented **CQV (Commissioning, Qualification, and Validation ) Manager ** to lead the execution of commissioning ... alignment on validation strategies includes CSV strategy. + Coordinate with quality and manage the deviation and change control procedure during CQV phase. +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- BeOne Medicines (San Carlos, CA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in San Carlos, CA: **Job Duties:** Manage the entire GxP change control process ... and revise accordingly based on guidance and feedback from Quality team. Manage validation activities of cross...21 CFR Part 11, 210 & 211, GLP, GCP, cGMP (current Good Manufacturing Practice) regulations. Any suitable combination… more
- Curia (Rensselaer, NY)
- …in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control laboratory or sterile fill ... Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation ...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …formulation. The **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and processes to assure ... that pertain to Installation, Operational, and Performance Qualification. + Assuring cGMP compliance related to Qualification and Validation of… more
- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation... protocols. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
- AbbVie (North Chicago, IL)
- …Validation Section Manager , will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ ... Validation Specialists + This role serves to provide Quality Assurance oversight of site validation documents/...to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation + May supervise… more
- Danaher Corporation (Fargo, ND)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation ... improve human health. This position is part of the Quality and Regulatory Affairs Department located in Fargo, North...and will be responsible for representing the Analytical Method Validation team as a subject matter expert (SME) on… more
- Danaher Corporation (Fargo, ND)
- …a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation ... experience in a life sciences company + Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and… 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 ... be the global leader in radiopharmaceuticals. **Summary** The Senior Manager , QA for QC is responsible for quality...review, method development, validation , and transfer, equipment validation , and associated projects. The Senior Manager … more
- DuPont (Hemlock, MI)
- …to the Quality Management System [QMS] to meet healthcare market quality requirements (including Current Good Manufacturing Practice [ cGMP ] standards). This ... Work in a highly-matrixed and geographically-diverse business environment. + Develop and deliver cGMP & quality training to all required personnel involved with… more
- Hologic (San Diego, CA)
- Manager , Supplier Quality Auditing San Diego, CA, United States **Join Our Team as a Supplier Auditing Manager at Hologic** Hologic is seeking a committed ... Supplier Auditing Manager to become a vital part of our innovative...ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead and guide a team… more
- Cambrex High Point (Longmont, CO)
- …compliance with company SOPs, cGMP /cGLP standards and FDA/EU regulations. The Associate Manager of Quality Assurance leads and mentors the quality team ... You Matter by applying today! Job Overview The Associate Manager of Quality Assurance is responsible for...the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection… more
- Bristol Myers Squibb (Warren, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . The Portfolio Delivery Manager supports the successful operation of facility, laboratory, and business ... The incumbent's focus is support of small to medium size validation projects, such as new product introduction, facilities/utilities upgrade and modification,… more
- Actalent (Orlando, FL)
- …Actions (CAPA). Manage change control for processes, materials, and equipment affecting product quality . Train staff on cGMP , SOPs, hygiene, and quality ... Description Ensure facility compliance with cGMP regulations (21 CFR Part 111 for dietary...ISO 22716 for skin care). Maintain and oversee the Quality Management System (QMS), including SOPs, work instructions, and… more
