- Develop, implement, and maintain GMP quality management systems, policies, and SOPs
- Ensure GMP compliance of manufactured drug substance, drug product, labeling, and packaging of clinical materials
- Conduct review of MBRs and EBRs and perform final product disposition
- Perform quality management review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records
- Review and approve product specifications, test methods, qualification/validation protocols and reports
- Identify compliance risks, perform risk management, and implement risk mitigation, as applicable.
- Monitor, track, and trend GMP quality systems and establish metrics
- Manage GMP audit activities, including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits
- Manage investigational product complaints and are investigated to ensure compliance
- Establish inspection readiness program
- Manage GMP training and provide quality training as appropriate
- Perform other duties as require
- Minimum Bachelor's degree in a relevant scientific discipline or equivalent
- Minimum of 8 years of pharmaceutical industry experience in CMC/GMP QA
- Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance
- Experience working with CDMOs, vendor selection, and management
- Proven ability to thrive and enable success in a cross-functional and collaborative environment
- Strong communication and interpersonal skills (maintain positive relationship and open communication)
- Ability to multi-task, shift priorities, and work in a fast-paced environment
- Detail oriented and well organized
- Team player, professional demeanor, enthusiastic, and self-motivated
-
Director of Quality Assurance
2 weeks ago
Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · Ready to make your application Please do read through the description at least once before clicking on Apply. ...
-
Director of Quality Assurance
3 weeks ago
Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · As the Director of Quality Assurance, you will be responsible for: · Leadership of entire QA function including ...
-
Quality Assurance Manager
2 weeks ago
Veritas Search Group Boston, United StatesSenior Manager, Quality Assurance (Med Device / Combination Products) · Do you have the right skills and experience for this role Read on to find out, and make your application. · Location: Fully Remote · Scope of Work: · The Senior Manager, Quality Assurance (Med Device / Co ...
-
Quality Assurance Specialist
3 weeks ago
BioTalent Boston, United StatesIntroduction · We are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis. · This role will offer you · Accelerated career growth on a team with a proven ...
-
Director of Quality Assurance
1 week ago
Albion Rye Associates Boston, United StatesDirector, Clinical Quality Assurance · Location: Boston, Massachusetts · Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance. ...
-
Quality Assurance Manager
3 weeks ago
Connect Life Science Boston, United StatesPosition: Contract Quality Manager · Location: Boston – Hybrid · Duration: 12 Months Contract · A medical device manufacturer, bringing a device to the market are seeking a Quality Manager who is a critical thinker, data driven, and quality minded. · Job Responsibilities: · pl ...
-
Quality Assurance Manager
19 hours ago
RADCUBE | Rapid Technology Solutions Boston, United StatesPrimary Responsibilities · • Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · • Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. · • Identify systemic p ...
-
Auditor Quality Assurance
1 week ago
JetBlue Boston, United StatesPress Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · Select how often (in days) to receive an alert: · Category: · Administration · Position Summary · The Quality Assurance Auditor is responsible for performing audits as required by Feder ...
-
Quality Assurance Analyst
2 weeks ago
Motion Recruitment Partners LLC Boston, United StatesSummary of the Position Looking for anexperienced quality assurance tester to join its Enterprise Services development team. In this position, the candidate will design and develop test plans for user requirements, technical and usability verification and validation of new and ex ...
-
Quality Assurance
3 weeks ago
Lazarus AI Boston, United StatesLazarus AI creates dynamic, highly accurate machine learning APIs to solve the data extraction and data activation challenges of our customers. Our latest innovation, RikAI, is a large language model that extracts data from any document without training, regardless of type, forma ...
-
Quality Assurance and Training Fellow
5 days ago
Beth Israel Lahey Health Boston, United StatesJob Type: Regular · Time Type: Part time · Work Shift: Day (United States of America) · FLSA Status: Non-Exempt · When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. · The Quality Assurance Fellow, reporting to the Chai ...
-
Software Quality Assurance Engineer
2 weeks ago
Motion Recruitment Boston, United StatesOur company is looking for accomplished and highly skilled Quality Assurance Engineers who are in the Greater Boston area. Motion recruitment works with companies across the country from large enterprise companies to brand new start-ups in all different industries. Our roles are ...
-
Quality Assurance test Manager
3 weeks ago
MatchPoint Solutions Boston, United StatesJob Description · Job Description · Position Title: Quality Assurance test Manager · Location: Boston MA - Hybrid Position · Duration: One Year Plus · Hours Per Week · Rate : $60/hr C2C · Client state of MA · Position Summary · The BEST QA Test Manager plays a critical role ...
-
Quality Assurance Test Analyst
3 weeks ago
HexaQuEST Global, Inc. Boston, United StatesPosition Summary · Working closely with the QA Test Manager, the QA Test Analyst is responsible for executing tests, validating user roles, and contributing to the creation of comprehensive test artifacts. This role involves collaboration with Subject Matter Experts (SMEs) to un ...
-
Senior Manager, IT Quality Assurance
2 weeks ago
Commonwealth Care Alliance Boston, United States**Why This Role is Important to Us:** · The Senior Manager, IT Quality Assurance is part of the Business Solutions team responsible for QA testing, product management and solutions delivery. This role is the primary owner for the QA Managed Services program and will be critical ...
-
Quality Assurance Test Manager
2 weeks ago
Dice Boston, United StatesDice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking the following. Apply via Dice today · Our Client, an independent agency who oversee financial systems as well as manage external sing ...
-
Quality Assurance Test Manager
2 weeks ago
NavitsPartners Boston, United StatesJob Description · Job Description · Position: · Quality Assurance Test Manager · Duration: · 18-24 months · Hours Per Week: · 37.5 · Location: · Hybrid (Boston, MA) · Position Summary: · The QA Test Manager plays a critical role in ensuring the quality and compliance of the ...
-
Software Quality Assurance Analyst
3 weeks ago
HexaQuEST Global, Inc. Boston, United StatesJob Description : · PROJECT OVERVIEW: · This project will, through a series of iterative improvements, knit the various processes together into an Integrated Eligibility and Enrollment program to provide constituents with a unified view of applying, managing, and being notified ...
-
Senior Quality Assurance Specialist
3 weeks ago
DPS Group Global Boston, United StatesSummary · DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site. · Responsibilities · Perform batch disposition, batch record re ...
-
Director, GCP Quality Assurance
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiov ...
Director, GMP Quality Assurance - Boston, United States - Imbria Pharmaceuticals
Description
Company Overview
Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to symptoms and functional deficits. Our lead investigational product candidate, ninerafaxstat, has completed Phase 2 clinical trials in non-obstructive hypertrophic cardiomyopathy (nHCM), stable angina, and in patients at high risk of developing cardiometabolic heart failure with preserved ejection fraction (pre-HFpEF). In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. Part 2 of our Phase 2 trial, IMPROVE-DiCE, in patients with cardiometabolic HFpEF, is ongoing with topline results expected in early 2025. For additional information, please visit
Position Overview
The Director, GMP Quality Assurance will lead the GMP quality function by supporting and providing oversight of CMC activities, establish and manage GMP quality systems, and ensure GMP compliance. The candidate will be a hands-on and actively involved in executing GMP QA strategy, collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues and business partners. Note: This position requires the incumbent to reside in the Boston area.
Responsibilities
Qualifications
This position requires the incumbent to reside in the Boston area. We offer a competitive total compensation package and invite you to consider a career with Imbria
