Senior Clinical QA & Compliance Leader (GCP/GLP)
Scorpion Therapeutics
Scorpion Therapeutics seeks an Associate Director, Clinical QA to provide hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. This role leads audits of CROs, laboratories, and investigator sites domestically and internationally, manages quality events, deviations, and CAPAs, and reviews key study documentation. The incumbent will support vendor qualification, oversight, and inspection readiness, develop and maintain #J-18808-Ljbffr Scorpion Therapeutics
$171.2k - $256.8k
...area of Boston, Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the Executive Director, Quality, is... ...responsible for leading quality assurance oversight across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory requirements....SeniorContract work- Korro Bio is seeking an Associate Director, Clinical QA to oversee quality across clinical and nonclinical programs, ensuring GCP/GLP/GCLP compliance. The role emphasizes auditing CROs, labs, and sites in the US and abroad, with practical risk-based judgment to protect...Senior
- ...PharmaceuticalsSelling Points Drive clinical quality excellence in a hybrid... ...regulatory initiatives for compliance success. Collaborate across... ...adherence to Good Clinical Practices (GCP) and regulatory standards... ...preventive actions.Conduct GLP and GCP vendor audits, ensuring...SeniorRemote work
- Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers across the clinical program and ensures timely, high-quality deliverables. The candidate...SeniorContract work
- ...Tango Therapeutics seeks a Director of GCP & GLP Quality Assurance to oversee compliance across clinical trials and nonclinical laboratory operations in Boston. This... ...sites, vendors, systems, and processes Provide QA oversight of GLP studies at contract research laboratories...SeniorContract work
$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study... ...ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations,... ...candidate brings direct, hands-on GCP QA experience supporting clinical...SeniorFull timeSummer workRemote workFlexible hours2 days per week- Dana-Farber Cancer Institute in Boston seeks a Clinical Trials Monitor to ensure regulatory compliance across the DF/HCC consortium. The role includes designing and implementing a robust monitoring program, performing remote reviews and onsite visits, and guiding staff...SeniorRemote work
$185k - $235k
...Therapeutics is seeking a Senior Director Quality GCP to provide... ...active pre-clinical and clinical programs... ...closely with industry leaders in Boston and... ...a risk-based GCP compliance program. Support... ...remediated.Provide QA GCP review and... ...ICH, MHRA, etc.). GLP experience a plus...Senior- ...of Companies in Cambridge, MA, is seeking a senior CPL to lead strategic medical guidance for preclinicalto-clinical oncology development. The role requires MD/DO... ...teams, designing development plans, and ensuring GCP compliance throughout translational programs in oncology...Senior
$137k - $215.27k
...assurance oversight of the global clinical research programs in Research... ...of significant quality and compliance risks to key stakeholders and... ...:Provide expertise in GCP compliance interpretation, consultation... ...appropriate solutions to senior management for immediate and...SeniorMinimum wageWork at officeLocal areaImmediate startNight shift$215k - $322.4k
...sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and... ...strategic partner to functional leaders across product modalities responsible... ...both non-regulated and GLP work), Biomarker Development,...SeniorFull timeWork experience placementSummer workLocal areaRemote workFlexible hours2 days per week$175k - $195k
...Senior Director, Clinical OperationsSkip to main contentYou may choose to display... ...functional alignment, ensuring compliance with global regulatory... ...timelines. • Ensure adherence to GCP and applicable regulatory... ...executed in accordance with GLP requirements and development...SeniorContract work- ...seeks a Sr. Director, Research and Development Quality Assurance to lead day-to-day GCP/GLP/GVP quality operations, set strategy, budgeting, and team development across non-clinical and clinical trials from first-in-human through commercial authorization. The role...Senior
- ...Health in Cambridge, MA, is seeking a Senior Clinical Regulatory Specialist to oversee regulatory... ..., and CROs, ensuring regulatory compliance and inspection readiness. Bring 4+ years... ...regulatory or research operations, strong GCP/FDA knowledge, and experience with CTMS...Senior
- Novartis Group of Companies seeks an Executive Clinical Program Leader to provide strategic medical leadership across Translational Clinical Oncology programs in Cambridge, MA. The role spans from early target identification through development, partnering with teams to...Senior
- Novartis in Cambridge, MA is seeking a Senior Clinical Pharmacology Leader (CPL) to provide strategic medical guidance for preclinical to transition decision point programs in oncology. The role is hybrid with onsite preference for local candidates. Level depends on skills...SeniorLocal area
- Korro seeks a senior clinical operations leader to drive early phase global trials in rare diseases. You will oversee CROs, study design, budgets, and timelines, collaborating with cross-functional teams to achieve program milestones. The role requires 8+ years in clinical...Senior
- A leading clinical development firm is seeking a Senior Director of Business Development to cultivate strategic partnerships and lead enterprise engagements. You will be responsible for driving account growth and ensuring client satisfaction while working closely with cross...Senior
- ...powering the acceleration of clinical research to transform... ...world-wide.As a Senior Clinical Regulatory Specialist... ..., consistency, and compliance, identifying gaps and driving... ...in monitor visits, QA/QC projects, site-level... ...Clinical Practice (GCP), applicable FDA regulations...SeniorTemporary workWork at office2 days per week
- Novartis is seeking an Executive Clinical Program Leader to provide strategic medical leadership across early oncology development programs in the Translational Clinical Oncology portfolio. The role spans from target identification through transition to later-stage development...Senior
$275k - $285k
...Senior Director, Clinical OperationsCambridge, Massachusetts or Oakland CaliforniaAt Aditum Bio... ...This role requires a collaborative leader who is equally comfortable serving... ...Quality & Continuous ImprovementEnsure compliance with ICH-GCP and applicable global regulations...SeniorFull timeContract workLocal area$217.6k - $326.4k
...DescriptionGeneral Summary:The Sr. Director, GCP Operational Quality will... ...strategies and plans enabling clinical quality outcomes and real time... ...clinical quality, and compliance for assigned programs. This... ...overall quality strategy across QA functions (e.g. audit, operations...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$231.99k - $347.98k
Position: Senior Director, Head of Rare Neurology Thought Leader LiaisonsLocation: Boston, MA (US Headquarters for Alexion... ...in thought leader engagement, clinical acumen, regional strategy... ...marketing operations, legal, and compliance to ensure regional programs meet...SeniorFull timeTemporary workLocal areaNight shift3 days per week$228k - $342k
...position summary:The Senior Director, Quality... ..., Digital Systems & Compliance, serves as a pivotal leader within the Quality organization... ..., Manufacturing, Clinical, and business... ...enterprisePartner with QA leadership and... ...experience (e.g., GMP, GCP, IT). Experience working...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$119.7k - $222.3k
...of artificial intelligence (AI) enabled strategies to transform clinical pharmacology support of transformative new medicines. The... ...Principal Scientist II. 4+ years of experience to be considered for Senior Principal Scientist.Extensive and in-depth knowledge of pharmacokinetics...SeniorFull time- ...Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-impact leader who will drive the operational engine... ...Regulatory Quality & Compliance Ensure all trials are conducted in strict accordance with ICH/GCP requirements, applicable regulations...SeniorWork at office
- ...Shaping the Future of Clinical Research Adams Clinical... .... Job Role The Senior Manager provides site-... ...execution, regulatory compliance, strategic alignment... ...approachable and accountable leader who builds strong... ...required ~ Knowledge of GCP, FDA regulations, and...SeniorWork at officeLocal areaRelocation
- A nonprofit organization is seeking a Senior Finance Officer to oversee finance operations across various entities, ensuring robust financial management and compliance. The ideal candidate will have over 7 years of nonprofit finance experience, expertise in Sage Intacct...SeniorRemote work
$138k - $190k
Job Description The Senior Manager, Clinical Quality Assurance is responsible... ...and oversight of GCP activities related to... ...both quality and compliance of Deciphera sponsored... ...review or revise Clinical QA SOPs to assess... ...and application of GCP, GLP and ICH requirements,...SeniorContract work- ...timelines and budget Leads the regional clinical operations team (including... ...on study progress in the region to senior management and Global Clinical Study... ...activities in region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations...SeniorLocal areaWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Clinical QA & Compliance Leader (GCP/GLP). Be the first to apply!
- recruitment team leader Cambridge, MA
- market leader Cambridge, MA
- manufacturing team lead Cambridge, MA
- mobile team lead Cambridge, MA
- leader Cambridge, MA
- grocery team leader Cambridge, MA
- team lead data science Cambridge, MA
- remote team lead Cambridge, MA
- team leader training Cambridge, MA
- team leader production Cambridge, MA



