Quality Assurance Director, External & CMC (Biologics)
Scholar Rock, Inc.
Scholar Rock in Cambridge, MA is seeking an experienced Director of Quality Assurance to lead External and CMC QA. This role provides governance over contract manufacturers and labs, ensuring GMP/GxP compliance and product release for clinical and commercial use. You will partner with manufacturing, QC, MSAT and other teams to build a robust quality system and maintain inspection readiness. The ideal candidate has a BS/MS in a scientific field, 12+ years in pharma/biotech with 5+ years in #J-18808-Ljbffr Scholar Rock, Inc.
- ...critical unmet need. As a global leader in myostatin biology, a field focused on proteins that regulate muscle... ...Rock is seeking an experienced and motivated Director of Quality Assurance to support External and CMC Quality Assurance. This role will provide oversight...SuggestedContract work
- Scholar Rock seeks an experienced Director of Quality Assurance to support External and CMC Quality Assurance. You will oversee external partner governance for manufacturing, testing and release of biological products, and collaborate with CMC teams to maintain quality...Suggested
$135.46k - $203.19k
Job Title: Associate Director, External QualityLocation: Boston, MA Hybrid... ...of RCs.The Role:AD, External Quality - Radio Conjugates is accountable... ...to regulatory submissions (CMC quality sections) and post-... ...in pharmacy, Chemistry, Biology, Engineering, or related scientific...SuggestedFull timeContract workTemporary work$226.1k - $339.1k
...DescriptionGeneral Summary:The Senior Director, Analytical Development is a senior... ...Manufacturing, Process Development, Regulatory, Quality, CMC, and external partners to generate high-quality... ...characterization of cell, gene and biologic therapy processes and products. This...SuggestedFull timeSummer workFlexible hours$184k - $253k
...This Role: As the Head of Global Product Quality for Biologics, you will lead a dynamic team... ...activities between business partners, the CMC Asset Team, and the Quality organization... ...of specifications. Represent Biogen at external forums to stay abreast of emerging expectations...SuggestedTemporary workWork at officeLocal area$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture. This position...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week$94.6k - $141.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced... ...be a key member of the Vertex Biologics and Devices Quality Team,... ...timely quality direction in support of external drug substance manufacturing and disposition...Full timeContract workSummer workRemote workFlexible hours2 days per week$176.9k - $221.22k
...Innovation!Position Summary:The Director of Analytical Development and Quality Control will lead the... ...methodologies to support biologics product development from... ...transfer to internal and external manufacturing and QC labs... ...ICH guidelines.Support CMC strategy, inspections, and...$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per week- ...Vertex Pharmaceuticals LLC in Boston seeks a Director of CMC Quality Compliance to lead inspection readiness and cross-functional quality programs across GMP areas, including external CMOs and internal facilities. You will shape governance, drive risk-based decision...
- ...Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems. The role requires...
- ...Biosciences, Inc. is seeking an Associate Director of QA Oversight for QC and CTO to lead... ...ensure compliant testing across internal and external labs. This role focuses on cGMP... ...oversee audits, and ensure alignment on quality agreements and regulatory expectations while...
$116k - $174k
...role will report to the Director of Quality and operate across... ...new role will support CMC development and... ...The Manager, Quality Assurance, will provide GMP QA... ...Operations, Regulatory, and external manufacturing... ...Degree in Chemistry, Biology, Engineering or related...Contract work$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit... ...Development, Supply Chain, external vendors, and internal company... ...appropriate Quality oversight of CMC and analytical strategies,... ...experience supporting biologics development, including GMP and...Contract workFor contractorsShift work$147.5k - $221.3k
...Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs for external manufacturing sites. The role... ...collaboration to evaluate quality compliance, drive continuous improvement... ...field ~8+ years of relevant CMC quality or compliance...- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This... ...oversight, and cross-functional collaboration with CMC teams to drive quality excellence and continuous improvement....
$180.8k - $271.2k
# Snr Director, Quality CGT Personalized MedicineVertex PharmaceuticalsBoston... ...participating in key CMC Quality initiatives to... ...CGT internal and external quality operations,... ...CGT treatment journey assuring GMP requests are... ...cell and gene therapy, biologics, and advanced therapy...Summer workRemote workFlexible hours2 days per week$60 - $80 per hour
...Job Title: Quality Assurance Manager Job Description This role leads and supports quality... ...and quality control activities for biologics manufacturing, with a strong focus on... ...for both internal manufacturing and external contract manufacturing partners. This...Full timeContract workTemporary workMonday to Friday$105k - $150k
...Manager, Product Quality Boston, MA Centessa... ...to the Executive Director, GMP Quality Assurance, this individual will... ...Technical Operations, CMC Development,... ...Clinical Supply Chain, and external manufacturing... ...degree in Chemistry, Biology, Pharmaceutical Sciences...Full time- ...Where a job isn’t merely a job but the start of a career where you can flourish. Job Summary The Food Safety & Quality Assurance Director ensures that multiple food service locations—operate with the highest standards of food safety, sanitation, and product...Local areaRemote workFlexible hoursShift work
$240k - $305k
...preserves vision and quality of life. For... ...Summary The Executive Director, GCP Quality Assurance provides strategic... ...vendors, and other external partners supporting... ...understanding of drug and biologic development,... ...of nonclinical and CMC/manufacturing processes...Temporary work$240k - $305k
...also preserves vision and quality of life. For more... ...Executive Director, Product Quality to serve... ...across Product Quality, CMC, manufacturing, analytical and QC activities, external manufacturing and testing... ...strategies supporting biologic and, as applicable, small...Contract workTemporary work- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview An... ...company developing next-generation biologics and engineered fusion protein... ...Collaboration Partner with CMC, Process Development, MSAT, Regulatory, and External Manufacturing teams to support...
- ...current.• Provide support during internal and external audits and ensure that assigned audit... ...CGMP regulations• The ability to apply quality systems and procedures to ensure... ...Compliance, or manufacturing• Must have previous biologics, biotechnology, pharmaceutical or...Immediate start
$184.6k - $277k
...DescriptionGeneral/Position SummaryThe Director, Manufacturing Process & Technical Quality provides Quality... ...Chain, Regulatory, and external partners, the Director... ...a site, program, CMC, or R&D leadership team... ...Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).· In depth...Full timeSummer workRemote workFlexible hours2 days per week- ...SDO seeks a detail-oriented professional to serve as Director of Compliance and Quality Assurance.The Supplier Diversity Office’s Compliance and Quality... ...public service, and responsive service to internal and external stakeholders.· Anticipates program needs, identifies potential...Full timeContract workPart timeFor contractorsWork experience placementWork at officeFlexible hours
$112.1k - $154.2k
...reliable milestone verification, maintaining visibility on gameplay quality status and risks, and continuously improving QA workflows,... ...Stakeholder Collaboration: Partner with development, production, and external QA vendors to coordinate dependencies, gameplay requests, and...Full timeCasual workWork at officeHome officeFlexible hoursShift work$99k - $232k
...product development and manufacturing processes, with an emphasis on quality management systems, validation, and Veeva-enabled solutions... ...: Analytics/Data Science, Artificial Intelligence/Robotics, Biology/Biomedical Sciences, Business Administration/Management, Computer...Full timeH1b$184.6k - $277k
...Vertex Pharmaceuticals seeks a Director of CMC Quality Compliance to lead inspection readiness and compliance programs across internal and external manufacturing sites. This role provides technical and strategic oversight of GMP compliance, quality culture, and regulatory...Work experience placement$200k - $240k
...MATechnical Operations - Quality Control /Full-Time /On... ...leader in myostatin biology, a field focused on... ...experienced and motivated Director of Global Quality... ...lifecycle activities, external laboratory oversight,... ...Development, MSAT, and Quality Assurance to support commercial...Full timeContract work
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