Director, CMC QA: Global Quality & Vendor Oversight
Korro Bio, Inc.
Korro Bio, Inc. in Cambridge, Massachusetts is seeking a Director, CMC QA responsible for quality oversight in drug manufacturing and testing. The role requires a strategic yet hands-on approach to ensure compliance with current Good Manufacturing Practices (cGMPs) and effective vendor management. The ideal candidate will thrive in a lean QA environment and support global clinical development programs through robust quality systems and regulatory adherence. #J-18808-Ljbffr Korro Bio, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, CMC QA: Global Quality & Vendor Oversight in Cambridge, MA vacancy
- ...on human health. Position Summary The Director, CMC QA will be responsible for providing quality oversight and direction to Korro Bio\'s vendors to ensure that drug substance, drug product... ...compliance in support of Korro Bio\'s global clinical development programs. #J-1880...Quality
$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be... ...while driving inspection readiness, vendor oversight, proactive risk governance, and continuous... ..., and partner with business and QA stakeholders to embed quality into operational...QualityWork experience placementRemote workWorldwideShift work$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston... ...for the strategic oversight and execution of a portfolio... ...Strategy, Regulatory CMC, Labeling, Publishing,... ...completeness, quality, and compliance* Identifies... ...management staff including vendor functional service...QualitySummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...Summary The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development... ...facilities. Manages QA On The Floor and QA... ...parties including CROs, Vendors and investigator sites... ...in-depth knowledge of global GMP requirements and managing...QualityWork experience placementSummer workRemote workFlexible hoursDay shift2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$222.3k - $302.9k
...the Role We are seeking a Director/Senior Director, CMC, Drug Substance to manage... ...accordance with applicable quality and regulatory standards.... ...authorities. Provide strategic oversight for regulatory... ...Experience with CDMO selection, vendor management, contracting, issue...QualityTemporary workWork at officeRemote workFlexible hours2 days per week$161.5k - $202k
...Position The Associate Director, GMP Quality Assurance is... ...procedures. This role supports CMC development activities... ...Ensure compliance with global regulations (e.g., FDA... ...and reports Perform QA review of executed batch... ...Experience with CMO oversight or virtual manufacturing...QualityWork at officeLocal areaRelocation3 days per week$155k - $190k
...You’ll Do The Associate Director, Analytical Development and Quality Control will support... ...authoring of relevant CMC sections to enable global regulatory filings Participate... ...as needed for vendor technology transfers... ...analytical activities oversight Required Qualifications...QualityFull timeLocal areaFlexible hours3 days per week$185k - $260k
...an experienced Clinical Quality professional at the Associate Director / Director level to... ...readiness, program quality oversight, and vendor oversight as Beam... ...Serve as the Clinical QA Lead for assigned studies... ...supporting FDA and other global healthy authority (e.g....QualityFull time$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle... .... Provide CMC regulatory guidance to manufacturing, quality, and process/analytical development groups. Interpret...Quality$216k - $324k
Senior Director, Manufacturing Technical Sciences Quality Assurance (Hybrid) page is loaded##... ...Technical Sciences QA is accountable for... ...technical quality oversight of cell and genetic... ...& implement CMC and Analytical Quality... ...Skills*** In-depth global regulatory agency knowledge...QualitySummer workRemote workFlexible hours2 days per week3 days per week- ...Therapeutics is seeking an Associate Director, Global Scientific Communications, who will... ...with GPP2022 and ICMJE guidelines. Vendor & Budget Oversight: Partner with and manage external scientific... ...writing agencies to ensure high-quality deliverables, timeline adherence,...QualityWork at officeLocal area3 days per week
$142.5k - $256.5k
Associate Director, Global Regulatory-CMC The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more... ...templates Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls Provide...QualityPermanent employment$159k - $195k
...What You’ll Do The Associate Director, Clinical Oversight (ADCO) provides strategic... ...framework that ensures high-quality trial execution, regulatory... ..., and inspection readiness globally. Required location:... ...Review contracts and approve vendor invoices Qualifications 1...QualityFull timeWork at officeLocal areaFlexible hours3 days per week$169.4k - $266.2k
...best. As part of the Global Medical Affairs Oncology... ..., the Associate Director, Scientific Communications... ...amplification of data; manages vendors, freelancers, and... ...delivery of high‑quality medical publications in... ...writing agency, including oversight on execution of...QualityMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- A leading biotech company in Massachusetts is seeking an experienced Associate Director, R&D Quality. This role manages vendor quality, oversees audits, and drafts Quality Agreements. The ideal candidate should have over 8 years in R&D Quality, strong knowledge of compliance...Quality
$160.6k - $240.8k
...The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced... ...quality assurance oversight of clinical trial... ...and applicable vendors, across a range of study... ...programs. Partner with QA and business... ...guidelines and applicable global regulations and...QualityWork experience placementSummer workWork at office$142.5k - $256.5k
...Summary Reporting to the Exe. Director of Digital Operations... ...within Moderna’s CMC Digital organization and... ...external partners; lead multi‑vendor delivery models and optimize for cost, quality, and velocity. Partner... ...volunteer days, sabbatical, global recharge days, and a...QualityPermanent employment$150k - $195k
...Position Summary The Associate Director, Technical Operations CMC Strategy is responsible... ...collaborate closely with Quality, Regulatory Affairs,... ...Manage and provide technical oversight of formulation development... ...with applicable cGMP and global regulatory requirements....QualityContract workTemporary workRemote work- ...to apply for the Associate Director, R&D Quality role at BioSpace We are seeking... ...Quality with a focus on vendor quality. The role owns Quality... ...aids, and enable data‑driven oversight of vendors in a fast‑moving... ...That’s why our US benefits and global well-being resources are...QualityWork from home
- Job title: Director, US Advertising and Promotion, Global Regulatory Affairs Location: Morristown, NJ / Cambridge,... ...providing strategic direction and oversight for the day-to-day activities for... ...wellbeing benefits including high‑quality healthcare, prevention and wellness...Quality
$171.62k - $257.43k
...groundbreaking clinical studies? As a Global Study Director (GSD), you will play a... ...clinical trials, managing quality, timelines, budgets,... ...resources, investigational sites, vendors, and key project... ...activities and lead operational oversight at the study level.- Assist...QualityPermanent employmentContract workTemporary workFixed term contractWork at officeFlexible hours3 days per week$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications...QualityPermanent employmentWork at officeWork from home$192.6k - $260.6k
Overview Director, Clinical Quality Risk & Portfolio Oversight leads enterprise-wide quality intelligence... ...trends across studies, vendors, computerized systems,... ...partnering closely with other QA functions (including GLP... ...-level threats to the global clinical pipeline....QualityLocal areaRemote workShift work$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision... ...team with a goal to develop global regulatory CMC experience in gene therapy... ...submission activities. Interface with CMC and quality teams, including execution of change...QualityFull timeTemporary workRemote workFlexible hoursSolid Biosciences
Boston, MA4 days ago$55 - $65 per hour
...$65.00/hr General/Position Summary The Vendor Quality Management Specialist is responsible for... ...the company to demonstrate appropriate oversight of our third parties. The role contributes... ...delays, risks, or gaps in coverage to QA leadership. Support and process supplier...Quality- Position: Associate Director, Vendor Management Department: Patient Support Vendor & Program Operations... ...responsible for leading the strategy, oversight, and performance management of vendors... ...ensure external partners deliver high‑quality services that align with business...QualityContract work3 days per week
- ...located in Bedford, MA is looking for a Senior Quality Assurance Specialist. In this role, you will ensure compliance with global regulatory requirements and internal... ...while providing quality assurance oversight across CMC development, Quality Control, Analytical...Quality
- A leading healthcare solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate will provide quality assurance oversight for clinical research programs, ensuring inspection readiness and GCP compliance. A minimum...QualityHourly pay
- Senior Manager/Associate Director, Global Regulatory Affairs CMC About the Opportunity A growing biotechnology company is seeking an experienced Senior... ...to cross‑functional teams, including Manufacturing, Quality, Analytical Development, and Process Development. Review...Quality
$285k - $350k
...President, Head of Quality Assurance Watertown... ...quality assurance oversight for manufacturing,... ...functionally with the CMC, Regulatory,... ...compliance with applicable global regulations and to... ...CMO, CRO, CDMO, PV vendor, and clinical site... ...transferring into a QA role: Chemical...Quality
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, CMC QA: Global Quality & Vendor Oversight. Be the first to apply!
Related searches
- clinical quality manager Cambridge, MA
- director quality compliance Cambridge, MA
- quality regulatory manager Cambridge, MA
- director of clinical quality Cambridge, MA
- senior manager quality engineering Cambridge, MA
- director of quality Cambridge, MA
- quality supervisor Cambridge, MA
- training and quality manager Cambridge, MA
- quality compliance manager Cambridge, MA
- director global quality Cambridge, MA