Quality Operations Manager, GMP & CMC (Pharma)
Convergent Therapeutics, Inc.
A clinical-stage radiopharmaceutical company is looking for a Manager of Quality Operations to oversee quality assurance systems and support the CMC activities. The role requires at least 5 years of quality assurance experience in the pharmaceutical industry and expertise in GMP regulations. The candidate should have excellent communication and interpersonal skills, a strong track record in managing quality systems, and the ability to work in a fast-paced environment. This mid-senior level position offers a full-time role with travel of up to 15%. #J-18808-Ljbffr
- Fagron US is seeking a Quality Site Head for its 503B Outsourcing facility in Canton, MA,... ...leads QA/QC investigations, audits, and management reviews, while coordinating training, budgets... ...for a ~175-person site. Strong GMP knowledge and leadership are essential....Suggested
- ...The GMP Operational Quality Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. This role coordinates or executes activities on multiple complex projects with emphasis on QA GMP disposition of drug products...SuggestedContract workShift work
$85k - $130k
Team: Quality & Security & ComplianceCity: BostonState: MA Veeva Systems is a mission... ..., and communities.The RoleThe Quality Operations Program Manager role ensures the integrity, compliance... ...(eQMS)Good understanding of GxP (GMP, GCP, etc.) regulations, principles of...SuggestedWork at officeLocal areaRemote workWork from home3 days per week$141.7k - $173.19k
...organization's commitment to operational excellence, scalable project management, and digital transformation within CMC.The Manager, the CMC... ...Manufacturing, Supply Chain, and Quality representatives to ensure... ...risks).Working knowledge of GMP, quality, supply chain, and...SuggestedFull time$180k - $264k
...how health is understood and managed, and support the communities... ...close collaboration among R&D, CMC, Quality, and Supply Chain teams and a... ...are seeking an experienced GMP manufacturing project manager... ...manufacturing and fill‑finish operations. Demonstrated experience building...SuggestedFull timeFlexible hours- ...seeking an experienced Director of Quality Assurance to lead External and CMC QA. This role provides governance over... ...manufacturers and labs, ensuring GMP/GxP compliance and product release for... ...in a scientific field, 12+ years in pharma/biotech with 5+ years in #J-18808-Ljbffr...Contract work
$141.7k - $173.19k
...Intellia Therapeutics seeks a Manager of CMC Program Operations to lead operational excellence and digital transformation for chemistry, manufacturing... ...for operations reporting ~ Working knowledge of GMP, quality, supply chain, and regulatory requirements in biopharma...- Role: CMC Program Operations Manager leading digital transformation and operational excellence in biopharma... ...with Regulatory, Manufacturing, Quality, and Supply Chain teams, and track regulatory... ..., scripting); working knowledge of GMP, quality systems, supply chain,...
$116k - $174k
...report to the Director of Quality and operate across departments,... ...This new role will support CMC development and clinical... ...development cycle. The Manager, Quality Assurance, will provide GMP QA oversight for Tango’s... ...related field plus 5 years pharma manufacturing, packaging...Contract work$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and... ...partner closely with Technical Operations, Regulatory Affairs, Clinical... ...validation, product lifecycle management, and regulatory commitments.... ...appropriate Quality oversight of CMC and analytical strategies,...Contract workFor contractorsShift work- ...Pharmaceuticals Incorporated is seeking an Associate Director, GMP Operational Quality to oversee a Quality team, ensure compliant GMP activities,... .... You will coordinate with internal and external partners, manage QA for change controls, investigations, and CAPAs, and...
$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection... ...and associated governance across all GMP areas. This position focuses not just on... ...for inspection readiness, inspection management, and compliance programs across all GMP...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...and motivated Director of Quality Assurance to support External and CMC Quality Assurance. This... ...role is responsible for managing quality system records (change... ...across outsourced operations and support health authority... ...Strong working knowledge of GMP/GxP requirements, FDA/EMA...Contract work
$200k - $275k
...seeking a Director/Sr. Director, Quality Assurance to lead and scale our Quality Management System (QMS) as our small... ...appropriate Good Manufacturing Practice (GMP) oversight for our drug... ...close partnership with Clinical Operations, CMC, and external partners, the Director...Temporary work$167k - $300.7k
...RoleReporting to the Executive Director of Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio... ...multi-vendor delivery models and optimize for cost, quality, speed, and risk.Partner with Finance and Operations...Permanent employmentFull timeWork at officeWork from homeShift work- ...Senior Director of GMP Quality will establish and maintain quality systems, provide... ...independent quality oversight of CMC strategies, control strategies, and... ...partners including audits and performance management Advise Technical Operations, Regulatory Affairs, and executive...Contract work
- Scorpion Therapeutics seeks a CMC Program Operations Manager to lead digital transformation and drive operational excellence in cell & gene therapy... .... You will coordinate with Regulatory, Manufacturing, Quality and Supply Chain teams, monitor regulatory commitments, and...
- .... is seeking an Associate-level operations professional to join the Laboratory... ..., MA. The role covers R&D and GMP environments, emphasizing CMMS use, asset management, calibration, and cGMP-compliant... .... You will collaborate with Quality Assurance, Validation, and Maintenance...
$195k - $330k
...you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage programs, including... ...substance, drug product, analytical, quality, regulatory, and supply chain workstreams... ...CDMOs and CROs, technology transfer, GMP manufacturing, and commercial supply management...$180k - $195k
...Associate Director, Quality Assurance CMCBoston, MASeaport Therapeutics is a clinical-stage biopharmaceutical company advancing the... ...seeking an experienced Associate Director, Quality Assurance CMC to manage GMP quality assurance activities supporting clinical development...- ...Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate...
$210k - $320k
...and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of in-vivo... ...of the business, status reporting, risk management, escalation and resolution of issues.... ...partnering with Analytical Development and Quality Control.Develop and implement strategic directions...Full time$77k - $202k
...Description & SummaryThe Opportunity As a Pharma and Life Sciences R&D Operations Consultant, Senior Associate, you... ...client needs and deliver quality outcomes. Your role will involve mentoring... ...to optimize portfolio and resource management - Developing and implementing...Full timeContract workH1b- Judo Bio is seeking a Director of Quality Assurance to lead GMP and quality systems across outsourced manufacturing and testing. The role will drive... ...environment. The candidate should bring 10+ years in pharma/biotech QA, strong GMP knowledge, and proven leadership to...
- ...Therapeutics in Waltham, MA, is seeking an Associate Director, CMC Operations, to drive planning and execution across development programs,... ...with hub-based collaboration. The role requires 10+ years in pharma drug development, strong leadership, and advanced Smartsheet skills...Remote work
$188k - $230k
...A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will have over 10 years of experience in GMP Quality Operations and leadership...$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible... ...Team, influencing cross-functional alignment, proactively managing risk, and providing timely quality direction in support of...Full timeContract workSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development... ...associated CAPAs.Track performance metrics and report to Sr Management; develops tactics to improve performance...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$148k - $180k
...serve.This is hybrid role with 2-3 days per week onsite in our Waltham, MA or Newark, CA office.Position Summary: The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners...Full timeContract workWork at officeFlexible hours2 days per week3 days per week- Scholar Rock seeks an experienced Director of Quality Assurance to support External and CMC Quality Assurance. You will oversee external partner governance... .... The role requires leadership in quality, risk management, and a proactive approach to drive continuous improvement...
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