Senior Manager, GCP QA - Clinical Audits & Compliance
$160k - $180kOlema Oncology
Olema Oncology is seeking a Senior Manager for GCP Clinical Quality to oversee compliance and audit functions within clinical trials. This hybrid role requires strong knowledge of GCP regulations and a Bachelor’s degree in a scientific discipline. Ideal candidates should have at least 8 years of relevant experience in Quality Assurance, excellent communication skills, and a proven track record in regulatory inspections. The position offers a competitive salary between $160,000 and $180,000 annually, along with a comprehensive benefits package. #J-18808-Ljbffr Olema Oncology
- Olema Oncology is seeking a Senior Manager for GCP Clinical Quality to ensure compliance and improve processes in clinical trials. This position will involve auditing and preparing for health authority inspections, as well as collaborating across departments. Applicants...Senior
$265k - $300k
A biopharmaceutical company is seeking an Executive Director, Clinical Quality Assurance to lead QA operations focused on GCP, GPvP, and GLP compliance. The ideal candidate will have extensive experience in regulatory practices, strong problem-solving skills, and the ability...SeniorRemote job$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership... ...of Alkermes GLP/GCP/GVP quality programs to ensure compliance across global... ..., implements and manages risk-based quality... ...experienced Clinical QA Senior leader who... ...assessments, audit strategy, oversight...SeniorLocal areaWorldwide$160k - $180k
...presentations here. About the Role Senior Manager, GCP Clinical Quality As the Senior... ...teams to ensure GCP/GVP compliance, assisting in identifying... ...and plans and supporting audits. This hybrid role is based... ...the following activities: QA review/approval of deviations...SeniorWork at officeFlexible hours2 days per week$160k - $180k
...potential. About the Role As the Senior Manager, GCP Clinical Quality reporting to the... ...teams to ensure GCP/GVP compliance, identify and communicate... ...documents and plans, and support audits. This hybrid role is based... ...internal and external QA audits and developing risk‑...SeniorWork at office2 days per week- Healx is looking for a part-time Senior QA Auditor to lead quality assurance and compliance activities. You will work closely with the Global Head of Clinical Development, ensuring that processes meet GCP and GMP standards while collaborating with various teams in the company...SeniorPart timeFlexible hours
- ...Therapeutics, a clinical-stage biotechnology... ...for a Director/Senior Director, GCP Quality Assurance... ...serving as sponsor QA counterpart to... ...and reported in compliance with applicable regulations... ...standards, and manage issue escalation.... ...CRO, and vendor audits; review reports,...SeniorFull timeRemote workFlexible hours
- ...Manager/Sr. Manager, Clinical Operations Watertown, Massachusetts, United States What's the opportunity? LifeMine Therapeutics... ...according to the highest standards, in compliance with Good Clinical Practices (GCP), and within timelines and budget. Provide strategic...SeniorContract work
$270k - $300k
.... The Company’s clinical-stage pipeline includes... ...are seeking a Senior Director, R&D Quality (GCP–GLP–GvP) is a... ...-appropriate compliance with global GxP... ...and direction for QA activities supporting... ..., CAPA management, and ongoing performance... ...a risk-based audit strategy for...SeniorContract workTemporary workWork at officeLocal areaFlexible hours$138k - $190k
...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... ...senior management Audit Planning and Oversight...SeniorContract work$130k - $160k
...a Boston-based medical technology company, is seeking a Clinical Quality Assurance (CQA) Manager to lead their CQA team. In this role, you will shape the... ...ideal candidate will have a strong background in Clinical QA testing, regulatory knowledge, and team management....Senior- Hemab is a clinical-stage biotechnology company dedicated to... .... Position Overview The Senior Director, Quality Assurance GCP is a key role within... ...lifecycle. Key Responsibilities Audit Planning and Execution... ...Quality Events Management Oversee the management of...Senior
$164.5k - $222.5k
Associate Director, Clinical Quality and Continuous Improvement... ...Provides strategic QA oversight across... ...development procedures to ensure compliance with GCP requirements,... ...and multi-study issue management. Ensures that quality events, audit and inspection learnings...Full timeTemporary workLocal areaRemote workFlexible hours$247.2k - $334.4k
The Senior Legal Director, R&D and Regulatory is a strategic legal... ...development, and lifecycle management. This role provides expert... ...intelligence and enhanced oversight of clinical compliance frameworks. Reporting to... ..., and Legal colleagues on GCP compliance and related risk...SeniorFull timeTemporary workLocal areaFlexible hours$142.4k - $224.1k
...Description Our Clinical Research and... ...operational quality management and inspection... ...responses to audit and inspection... ...research division QA and acting as... ...and maintains GCP inspection procedures... ...and achieve compliance outcomes.... ...risks to Company Senior Management. Develops...For contractorsWorldwide$265k - $300k
A clinical-stage biotechnology company is seeking an Executive Director of... ...role requires expertise in GCP, GPvP, and GLP, ensuring compliance with regulations. Responsibilities include providing QA oversight, leading risk-based audit strategies, and maintaining inspection...Remote work- ...Clinical Quality Manager – Clinical Trial Audits We are looking for a clinical quality professional with hands-on GCP audit experience who can independently assess... ...risks, and strengthen compliance across global studies.... ...in Clinical Quality / QA (not solely clinical...
- South Shore Health System is seeking a Coding & Compliance Auditor to ensure medical coding accuracy and compliance. The role involves establishing audit processes, conducting training for clinical staff, and monitoring regulatory changes. Applicants should have at least...Senior
- Datavant is seeking a Client Coding Project Manager to provide superior quality in auditing risk adjustment coding efforts and ensuring compliance with organizational regulations. This role involves monitoring operations performance, providing training, and maintaining...Senior
- The Senior Project Manager, reporting to the Administrative Director of Quality and partnering closely... ...- including Hospital Quality, Compliance, Infection Control, Risk & Safety, and... ...quality goals. Partner with executive, clinical, and operational leaders to drive...SeniorWork at officeFlexible hours
- ...Senior Manager, Clinical Operations Boston, Massachusetts - Onsite A growing... ..., staff development, compliance initiatives, and clinical trial... ...Ensure compliance with GCP, FDA regulations, study protocols... ...partners Support audits, inspections, quality initiatives...Senior
$48 - $55 per hour
Vedanta Biosciences in Cambridge, MA is seeking a Senior Clinical Trial Associate to manage and support clinical trial activities, ensuring compliance with GCP guidelines. This role involves coordinating with internal and external stakeholders, and maintaining study-related...SeniorRemote jobHourly pay$252k - $269k
Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves... ...and operational oversight of GCP/GLP/GVP quality programs to ensure compliance in clinical trials.... ...activity and 8+ years in GCP management. The position offers a salary...Senior- ...Pharmaceuticals in Boston is looking for a Senior Manager, Investigational Supply Operations... ..., packaging, and distribution for clinical studies. You will ensure compliance with industry standards while... ...a strong understanding of GMP and GCP standards, and proficiency in...Senior
- ARTBIO is seeking a Senior Clinical Trial Manager to oversee the daily operations of clinical trials in Cambridge, Massachusetts. The ideal... ...functional teams, managing clinical sites, and ensuring compliance with GCP, ICH, and FDA regulations. Excellent communication and...Senior
- ...Bicara Therapeutics is seeking a Senior Project Manager to provide project... ...stakeholders. In partnership with the Clinical Operations Team, the Project... ..., and internal and external audit preparation and follow-up.... ...with solid knowledge of ICH/GCP and related guidelines and...SeniorWork at officeLocal area3 days per week
- ...Therapeutics in Cambridge, Massachusetts is seeking a Clinical Operations professional with 5-7+ years of... ...studies, overseeing budgets, and ensuring compliance with ICH-GCP guidelines. The ideal candidate excels in project management, possesses strong problem-solving skills,...SeniorRemote job
$127.7k - $269.3k
...been a core part of our DNA across our audit, tax, and consulting groups. That's why... ...seeking a highly accomplished Federal Tax Senior Manager to join our Lead Tax Services team.... ...forward-thinking tax planning strategies, compliance expertise, and technical tax research...SeniorLocal areaRemote workWorldwide$160.6k - $240.8k
...Associate Director, GCP Compliance The Associate Director... ...Quality Issues Management and other activities within... ...escalation of these events to Senior Management and other... ...Quality, Global Clinical Quality and other Subject... ...including inspection, audit activities Assist...Work experience placementSummer workRemote workFlexible hours2 days per week- ...Description & Requirements The Senior Director, Global Information Security... ...wide information security posture, risk management, and compliance maturity. Reporting to the CIO, this... ...effective, repeatable, and auditable, supporting both regulatory obligations...SeniorWork at officeLocal areaFlexible hours3 days per week
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