Director, Clinical Quality & Inspection Readiness
$185k - $260kBeam Therapeutics
Beam Therapeutics in Cambridge is seeking an experienced Clinical Quality professional to join their Quality Team at the Associate Director / Director level. This role involves leading GCP inspection readiness strategies, supporting clinical quality activities, and ensuring compliance with regulatory standards. The ideal candidate will have over 10 years of experience in clinical quality in the biotech sector. The position offers a competitive salary range of $185,000 — $260,000 USD based on relevant experience and qualifications. #J-18808-Ljbffr Beam Therapeutics
$252k - $269k
...Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality programs... ...clinical trials. This leader ensures the organization is ready for inspections, implements and manages risk-based quality systems,...SuggestedLocal areaWorldwide$265k - $300k
Executive Director, Clinical Quality Assurance Boston; San Francisco; Seattle About Jade Biosciences Jade Biosciences is a clinical‑stage... ...programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory...SuggestedWork at officeRemote work$185k - $260k
...Position Overview: Beam is seeking an experienced Clinical Quality professional at the Associate Director / Director level to join our grown Quality Team.... ...strategic and operational leadership for inspection readiness, program quality oversight, and vendor oversight...SuggestedFull time- Vertex Pharmaceuticals Incorporated seeks a Clinical Study Quality Lead (SQL), Associate Director for comprehensive quality assurance of clinical trial... ..., managing vendor relationships, and leading inspection readiness activities. A bachelor's degree along with 8+ years...SuggestedFlexible hours
- ...healthcare solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate will provide... ...assurance oversight for clinical research programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in the...SuggestedHourly pay
$192.6k - $260.6k
Overview Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence... ..., computerized systems, audits, inspections, deviations, CAPAs, and quality... ...oversight to enhance compliance, inspection readiness, and operational effectiveness. This...Local areaRemote workShift work$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay range: $120.00/hr - $170.00/hr Location: Cambridge, MA (Hybrid - 2 days onsite... ...Products Development (MPD) with the overall goal of inspection readiness. Serves as a Strategic Quality Thought Partner to Clinical...Temporary workFor contractorsWork at officeImmediate startNight shift2 days per week- ...Director of Clinical Quality Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional... ...Assurance Coordinating audits (internal, external) Inspection experience (FDA) Need to have worked in a development...Permanent employmentFor contractorsInterim roleLocal areaNight shift
$198k - $242k
...COMPANY OVERVIEW: Disc Medicine is a clinical-stage biopharmaceutical company... ...company is introducing a new role: Director of Clinical Quality Control. The successful candidate will... ...commercial licensure. Support GMP audits and inspections. Act as the team leader to ensure...Remote workFlexible hours$153.6k - $241.34k
Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description... ...audit program, hosting or leading regulatory inspections, investigations, and remediation activities on a global level...Temporary workLocal areaRelocation package$252k - $269k
Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves strategic leadership and operational oversight of GCP/GLP/GVP quality programs to ensure compliance in clinical trials. Candidates must have 15+ years of experience in clinical...- ...manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information,... ...website at eliquent.com. Key Responsibilities Real-time Inspection Readiness Develop, manage and contribute to ongoing maturity of GMP...Work experience placement
$160k - $187k
...Are you ready to join a team committed to making a meaningful impact... ...Functions Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA) is... ...quality issues. Support clinical inspection readiness activities for assigned...Summer holidayWork at officeHome office- A biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong...
- ...We are seeking an experienced Clinical Quality Assurance (CQA) Manager to lead and execute Good Clinical Practice (GCP) quality assurance... ...quality systems, with a strong emphasis on auditing and inspection readiness . This individual will collaborate closely with Clinical...
$140k - $160k
...strategic partner for global clinical development. Our unique... ...for conducting independent quality control (QC) assessments to... ...position reports to the Executive Director, Head of US Clinical... ...cross‑study trend analysis. Inspection Readiness Support Support inspection...Work at officeRemote workWorldwideRelocation package$200k - $245k
...LinkedIn. Summary of Position: Position Responsibilities Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment. Optimize core QMS processes (change control,...- ...submission, manufacturing ramp, and product launch. We need a Director of Quality who has been here before: someone who can hold the rigor... ...for a 70-person company moving fast, ensuring we’re inspection-ready without drowning in overhead, and scaling the system as we...Day shift
$265k - $300k
A clinical-stage biotechnology company is seeking an Executive Director of Clinical Quality Assurance to oversee quality assurance for clinical trials. This remote role... ...based audit strategies, and maintaining inspection readiness. The expected salary range is $265,000...Remote work$213.6k - $320.4k
Position Summary The Senior Director, Global Quality Systems holds a pivotal... ...roadmap for evolution ensuring readiness and sustainability for... ...into operating standards, inspection readiness, compliance and... ...Experience across preclinical, clinical, and CMC processes, with...Contract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS), reporting... ...efficiency, and sustained inspection readiness. As a key member of the Quality leadership... ...alongside organizational growth across clinical and commercial activities. This role...Local areaRemote work3 days per week
$229k - $280k
...conditions. What You’ll Do The Senior Director, Quality Systems is a high-impact leadership... ...Management System (QMS) to support global clinical development and future... ...Volume 4). Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory...Full timeLocal areaFlexible hours3 days per week$145.5k - $218.25k
...safe or helping find cures for cancer. Description The Director, Quality (Contamination Control and Microbial Excellence) at Thermofisher... ...(e.g., autoclaves, SIP, filter integrity testing). Inspection Readiness Support digitalization and innovation across PSG sites...Temporary workWork at office$215k - $260k
Job Summary The Senior Director, U.S. Quality is responsible for leading and executing the Quality Management strategy across the U.S.... ...with FDA and applicable regulatory requirements; lead U.S. inspection readiness and support regulatory interactions and audits....Temporary work- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview... ...enabling studies and early clinical development, this leader... ...transfer, and later-stage readiness. Grow, mentor, and manage... ...Represent QC in regulatory inspections and ensure readiness aligned...
$245k - $335k
...scholar rock to protein structures, the clinical-stage company is focused on... ...an experienced and motivated Senior Director of Global Quality Control. Reporting to the Head of Global... ...a phase-appropriate, scalable, and inspection-ready global QC strategy for a fully outsourced...Contract work$138k - $190k
...Senior Manager, Clinical Quality Assurance The Senior Manager, Clinical Quality Assurance... ...Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to... ...10% ~ Assist with inspection readiness, and regulatory inspections as needed...Contract work$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...Remote work$156.6k - $234.8k
...Description General Summary The Associate Director, GMP Operational Quality is responsible for oversight of... ..., working cell banks and clinical and commercial drug products internally... ...teams and functions for proactive inspection readiness across assigned programs. Provides...Work experience placementSummer workRemote workFlexible hoursDay shift2 days per week$137.8k - $206.8k
Job Description The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to... ...escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and...Remote workFlexible hours2 days per week
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