gmp quality

About the Position The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio’s portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports...

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and...

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and...

BioSpace seeks an experienced Quality Oversight Manager to provide independent governance of QA for Engineering, Manufacturing, and MSAT, ensuring cGMP and regulatory compliance. You will help ensure outputs meet quality standards and maintain a robust QMS. You will review and approve documentation and system deliverables, drive inspection readiness, and...

Civica is seeking an accomplished Quality governance leader to oversee engineering, manufacturing, and technical support activities ensuring cGMP, regulatory, and internal quality standards. You will review and approve QMS records, investigations, protocols, and system deliverables to sustain a robust QMS and inspection readiness for sterile injectable...

CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies...

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and...

Description The Manager, GMP Quality Operations is responsible for day-to-day Quality oversight of GMP manufacturing and testing activities across Viking’s external manufacturing network, supporting late-stage clinical development and future commercial programs. The Manager will work closely with Viking Quality, Technical Operations/CMC, Regulatory...

Vertex Pharmaceuticals Incorporated in Boston seeks an Associate Director of GMP Operational Quality Assurance to lead global validation programs and ensure cGMP compliance across product launches and continuous improvements. You will partner with internal stakeholders to standardize validation processes, drive CAPA actions, and oversee quality assurance...

The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and...

Job DescriptionJob DescriptionJob Title: Senior Manager, GMP Quality Duration: 6 Months (Contract)Work Schedule: 40 hours per weekLocation: RemotePay Rate:$100-$104 on W2 /hr.Role OverviewThe Senior Manager, GMP Quality will serve as a key Quality Assurance representative on cross-functional teams, supporting clinical and commercial manufacturing activities....

About the job Title: Clinical GMP Quality Assurance Manager Location: Greater Waltham, MA Area (Hybrid – 3 days onsite/week) Employment Type: Contract – 6 Months Status: Accepting Candidates About the Role Seeking an experienced Clinical GMP Quality Assurance Manager to provide quality oversight for clinical packaging, labeling, and pharmaceutical...

Overview: * This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager. * The purpose of this role is to work together with global or regional Quality Management teams, functional teams, and other stakeholders in a joint effort to clearly define the...

The Wright Group is seeking a Quality Technician to support quality across incoming materials, manufacturing, and finished product shipping in our Crowley, LA facility. You will collaborate with production, warehouse, and operations to ensure quality and food safety standards are met under cGMP guidelines. Responsibilities include inspecting materials,...

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals...

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Summary #LI-Remote Location: Remote/Canada or Remote/Mexico. For the role posting in Mexico, please see REQ- .Novartis will not...

Swanson Health Products is seeking a qualified Quality Systems professional to join our Fargo-based team. The role focuses on developing, writing, and implementing GMP policies and procedures to support our food, dietary supplement, and pharmaceutical manufacturing standards. You will coordinate GMP training, document control, supplier qualification, and...

Exelixis Inc. seeks an Operations QA Manager - Commercial to oversee end-to-end GMP operations at CMOs, including drug substance, product, renders, raw materials, packaging and labeling. You will assess vendor processes and review batch records, partnering to mitigate risks to products from vendor sites and collaborators. The role requires strong GMP...

Job DescriptionJob DescriptionThe Position At Maze, we're translating human genetic insights into precision medicines for patients with serious diseases. With our lead program, MZE829, preparing to advance into pivotal development and MZE782 in Phase 2, we are entering an important stage in building the capabilities needed to support late-stage development...

Job DescriptionJob DescriptionDuties:   Be the QA representative on cross-functional project teams.Responsible for communicating with the Quality and Production departments at domestic and international contract manufacturingorganizations, and within CLIENT's Quality, Supply Chain, CMC, and Commercial Manufacturingdepartments.Conducts product release...