Quality Systems Lead, GxP & Compliance
Socket.dev
Stoke Therapeutics in Bedford, MA seeks an Associate Director of Quality Systems to lead the QMS, ensure GxP compliance, and drive continuous improvement across quality processes. The role interfaces with CMC, Regulatory, Clinical Operations, and IT to mature systems for product development and clinical trials. You will manage change controls, audit programs, and risk assessments while fostering a culture of inspection readiness. Hybrid work with relocation to Waltham is anticipated. #J-18808-Ljbffr Socket.dev
- Kymera Therapeutics is seeking a Quality Systems professional to manage the operational infrastructure of the QMS, including... ...document control, training program management, and compliance monitoring. This role ensures GxP documents and personnel training records meet...Quality
- ...MA is seeking a senior QA leader to manage the Quality Management System and Validation programs. The role ensures compliance with regulatory requirements and company... ...Director, Quality Assurance and requires deep GxP experience. #J-18808-Ljbffr Ocular Therapeutix...Quality
- EyePoint is seeking a Sr. Manager Training & Quality Systems to lead the GxP quality training program and coordinate with GLP, GCP, and GMP partners... ...learning resources, SMEs collaboration, training compliance, and supporting audits. #J-18808-Ljbffr Initial Therapeutics...Quality
- ...Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes. The ideal...QualityCasual workMonday to Friday
$185k - $209k
...of the central nervous system and the eye that are caused... ...Associate Director, Quality Systems will support... ...systems for Stoke to ensure compliance with US and... ...administering Stokes QMS. Lead QMS changes and process... ...compliance with evolving GxP regulations and business...QualityTemporary workFlexible hours- EyePoint is seeking a Sr. Manager, Training, Quality Systems in MA (Watertown or Northbridge) with a hybrid schedule. You will lead the GxP Quality Training program, build... ...maintaining SOPs, managing the LMS, and reporting training compliance. #J-18808-Ljbffr EyePointQuality
$130.8k - $209.4k
The RoleThe GxP Endpoint Engineer will serve as the primary... ...and processes align with Quality Assurance (QA) guidance and compliance requirements.This role is... ...that supports operating system deployments, in-place... ...have aspired to build the leading mRNA technology platform,...QualityPermanent employmentFull timeWork at officeWork from home$251.77k - $307.72k
...an experienced QMS and Digital Compliance Senior Director to lead transformational change within our quality compliance organization. This... ...maturing the quality management system and digital compliance... ...policiesDevelop and implement GxP standards, procedures, and best...QualityFull time- Stoke Therapeutics is seeking an Associate Director of Quality Systems to lead the QMS, drive regulatory readiness, and partner with IT for system improvements. The role demands 10+ years of biotech/pharma experience, strong GMP knowledge, and a track record in audits and...Quality
- ...Davis Companies in Massachusetts seeks a Document Control & Quality Systems Coordinator to maintain SOPs, forms, specs, and training records... ...internal audits, supplier and internal CARs/SCARs, ISO 9001 compliance, and calibration program coordination. #J-18808-Ljbffr The...Quality
- Vericel Corporation, a leader in regenerative medicine, is seeking a Manufacturing Compliance Specialist to ensure cell therapy operations meet cGMP and quality systems. You will partner with Manufacturing, QA, QC, Engineering, Development and Supply Chain to investigate...QualityShift work
- Werfen is seeking a QS Specialist I to support the Quality Management System, ensuring GMP compliance and FDA/ISO standards adherence. You will assist CAPA activities, audits, and management reviews under supervision, contributing to quality improvements across the organization...Quality
$190k - $260k
...technologies, end-to-end services, and industry-leading manufacturing expertise to develop... ...efficiently.The Role:The Director, Quality Systems and Compliance provides strategic direction and... ...Owner / Digital Process Owner in a GxP environmentStrong expertise in global...Quality$135k - $155k
...in Burlington, MA is looking for a Sr. Manufacturing Compliance Specialist to ensure compliance with Good... ...therapy operations. This role requires expertise in Quality Management Systems and the ability to lead cross-functional projects. The ideal candidate will...QualityFull time- Werfen is seeking a Quality Systems Specialist I to assist in planning, coordinating, and improving the Quality Management System to ensure GMP, FDA and ISO compliance. You will support CAPA, audits, quality agreements, and management review activities under supervision...Quality
$200k - $260k
...Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of... ...We are seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to be a key leader within Crescent’s Quality...QualityContract workTemporary workFlexible hours$110k - $150k
...be a part of the process that leads to new cures. WORKING AT... ...JOB SUMMARY The Lead, Quality Control Technical Services (QCTS... ...ensuring that QC laboratory systems, instruments, software, and associated... ...for data integrity and GxP compliance. This role provides expert oversight...QualityLive inVisa sponsorship- ...used in product manufacturing. You will serve as SME in material inspection, material disposition, documentation review, and quality system compliance. The role requires 4+ years in a cGMP environment, strong attention to detail, excellent communication, and proficiency...Quality
- ...Bedford, MA seeks a seasoned Document Control Senior Specialist to oversee the corporate document control program within Quality Systems and Compliance. You will manage lifecycle controls in eDMS TrackWise Digital, ensuring documents are created, reviewed, approved,...Quality3 days per week
$95k - $245k
....Job Description Summary:The Systems Concepts and Design Division... ...internship cohorts•Ensuring the quality of technical work products... ...expense reports•Ensuring group compliance with Draper policies,... ...management to group members.Lead, mentor, build depth in their...QualityFull timeWork at officeLocal area- ....Position Summary:The Manager, Quality Management Systems & Validations is responsible for... ...activities to ensure compliance with regulatory requirements and... ...Validations responsibilities include leading and overseeing the validation of GxP systems and processes, managing...QualityLocal area
$250k - $273k
The Senior Director, Quality Compliance is responsible for providing strategic leadership and... ...industry best practices. This role leads key quality systems including supplier oversight,... ...continuous state of readiness across all GxP areas.Serve as inspection lead and primary...QualityWork at officeRemote work- PCI Pharma Services is seeking a QA Specialist II to ensure product quality and compliance across clinical and commercial products. The role emphasizes batch record review, CAPA management, and oversight of deviations and investigations to uphold GMP standards. The position...Quality
$178.1k - $244.86k
...access globallyACCOUNTABILITIES Lead end-to-end strategy... ...analytics, in partnership with systems teams, to optimize program design... ...deliveryChampion data standardization and quality, ensuring accurate,... ...program deliveryEnsure compliance with global regulatory requirements...QualityMinimum wageTemporary workLocal areaNight shift- ...Engineer with extensive experience in AS400/System-i. The role demands a strong background... ...ability to analyze complex programs and lead a team effectively. This position offers... ...settings and are committed to delivering high-quality support, this opportunity is perfect for...Quality
- ...inspections across R&D, ensuring adherence to FDA/EMA and ICH GxP standards. You will lead pre-, in-, and post-inspection activities, drive CAPA... ...mentor junior staff, develop inspection management plans, and support ongoing quality culture in a #J-18808-Ljbffr BioSpaceQuality
- ...Technology is seeking an Assistant Director for Research Systems and Data Operations. This pivotal role involves... ...implementing Oracle Fusion ERP, and ensuring high-quality data operations. The successful candidate will lead a team of analysts, manage reporting services, and...Quality
- Sun Pharmaceutical Industries, Inc. in Billerica seeks a Manufacturing Compliance Specialist to support compliance activities in manufacturing. This role ensures adherence to quality standards and coordinates activities across various departments including Manufacturing...Quality
- Harvard University is seeking a Lead Analyst for HR Systems to act as a functional lead across university-wide HR applications, including LMS and... ..., cross-functional collaboration, and delivering high-quality service while coordinating with IT, administrators, faculty...Quality
- ...Separations is seeking a Mechanical Build & Maintenance Lead for on-site work in Watertown, MA. You will lead the assembly... .... You will supervise wiring, controls, and mechanical systems, ensuring safety and quality. The role requires hands-on leadership, the ability to work...Quality
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