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Manager, Quality Assurance Operations
3 weeks ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
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Quality Assurance
1 week ago
Global Pharma Woburn, United States**Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...
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Quality Assurance Specialist
1 week ago
Deephealth Somerville, United States**Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...
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Quality Assurance Specialist
3 weeks ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
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Quality Assurance Specialist
3 weeks ago
DPS Group TSO Boston, United States**Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...
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Quality Assurance Program Manager
1 week ago
INTEGRA TESTING SERVICES Needham, United StatesThe Quality Manager is responsible for leading the Quality Program for all CE Services locations and managing the onsite Microbiology Laboratory. · The Quality Manager assumes overall responsibility in ensuring that the division maintains operational and quality systems in a stat ...
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Quality Assurance Test Manager
3 weeks ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
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Quality Assurance Lead
5 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Lead
3 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Manager
1 day ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
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Quality Assurance Specialist
2 weeks ago
Element Materials Technology Acton, United StatesOverview: · Element Materials Technology Boston-Acton, Inc. is looking for a full-time **Quality Assurance Specialist** to support the Quality Assurance Unit in a cGMP Microbiology Laboratory · **Responsibilities**: · - Comply with current Good Manufacturing Practice regulations, ...
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Quality Assurance Coordinator
3 weeks ago
MES Solutions, Inc. Norwood, United StatesOverview: · Are you a Medical Scribe who prides yourself on your strong writing/grammar abilities? Are you also looking to step away from a medical office and into a work-from-home position? · If you answered yes, then this might be the job for you because **MES **is looking for ...
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Quality Assurance Specialist
2 weeks ago
Axiomtek Methuen, United States**JOB BRIEF** · The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Leader on team member performance, maintains quality assurance documents and c ...
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Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
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Quality Assurance Technician
3 weeks ago
Ultra Electronics Braintree, United StatesUnleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. · Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldw ...
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Contract - Quality Assurance Specialist, Cmc
2 weeks ago
Vedanta Biosciences Cambridge, United States**Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...
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Director Of Quality Assurance
1 week ago
RPM ReSearch Waltham, United StatesTitle: Director of Quality Assurance CDMO · Location: Greater Boston, MA area · Generous Relocation Assistance provided · Onsite Presence Required · JOB SUMMARY · The Director of Quality Assurance is responsible for managing all aspects of the Quality Assurance while develop ...
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Quality Assurance Testing Lead
1 week ago
Global Atlantic Financial Group Opportunities Boston, United States**COMPANY OVERVIEW** · Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment firm that offers alternative ass ...
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Specialist, Quality Assurance
3 days ago
Moderna Norwood, United States**The Role**: · The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc. · **Here's What You'll Do**: · Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or es ...
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IT Quality Assurance Analyst
1 week ago
EG America LLC Westborough, United States**Position Summary**:The IT QA Analyst is a supporting role to Application Management and Technology services efforts within the IT department. The IT QA Analyst will be responsible for the testing and certification of new releases of software to the existing production environme ...
Manager/Sr. Manager GCP Clinical Quality Assurance - Waltham, United States - Lyra Therapeutics
Description
Lyra Therapeutics, Inc.is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases.
Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities.
LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery.
LYR-210 is designed for surgically nave patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.
These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.
Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance. The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. They will lead and/or support GCP audits, maintain inspection readiness, and manage key relationships internally and externally. This impactful role requires proactive GCP CQA support, independent audits, and effective communication to enhance clinical development practices.ResponsibilitiesActively contribute to cross-functional team meetings and provide guidance to GCP functional groups based on interpretation of current regulations to ensure best practices including risk-based managementProvide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellenceDevelop and manage Audit Plans and Audit ReportsOversee the audit response process and ensure acceptability of actions addressing findings during the various auditsIndependently conduct audits, including Clinical Investigator Site Audits, GCP Document Audits, internal Process Audits, and support Vendor/System auditsDraft, review, revise or provide input to GCP/GLP SOPs to assess consistency and compliance with regulatory requirements/internal standardsInteract and manage contract auditors to help facilitate audit scheduling, conducting pre-audit meetings, drafting and reviewing audit plans, agendas, confirmation letters, peer review audit reports as appropriateWork closely with GCP/GLP functional groups to ensure/coordinate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessaryProvide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and pharmacovigilance system management files and other relevant documents as neededEscalate issues of critical and major non-compliances and/or lack of urgency in remediation as appropriateDrive continuous quality improvement by communicating audit results, CAPAs, and providing GCP guidance to clinical teamsSupport health authority inspection preparation activities and provide oversight during inspectionsReview and contribute to various clinical documentationCompile and analyze audit metrics to identify trends for business groupsConduct GCP training sessions for business groupsWork directly with third party vendors and contractors, managing effective chain of communication related to GCP/GLP/GVP compliance Requirements Bachelor's degree in a related field, advanced degree preferred5+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance auditingExperience with using risk-based principles & decision making to ensure ongoing compliance at all stages of product developmentExperience working with all phases of clinical development, especially Phase IIISolid understanding and application of GCP/GLP guidelines and regulationsFundamental knowledge of US, EU, and international regulatory standards and guidelines for clinical trialsTechnical and administrative capabilities to independently conduct routine, complex, and for-cause auditsA well organized, self-motivated and independent work style with the ability to initiate and follow through on assignmentsExperience in inspection management with strong analytical and report writing skillsIdeal candidate will have broad experience in GCP/GLP environments, regulatory compliance and solid experience in GCP/GLP field auditingAbility to represent the CQA Department with professionalism and exceptional interpersonal skills; solid knowledge of negotiation and conflict management skills to assure effective interactions with internal and external stakeholdersProfessional communication skills, strong independent time management, and the ability to manage multiple projects concurrently while dealing with time demands, incomplete information, or unexpected eventsWillingness to travel (approximately 25%)At Lyra, we value creativity, leadership, and collaboration.
The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.
For consideration, please submit cover letter and CV.
