Global Head of Quality — Devices & Combination Products
Biogen, Inc.
Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support both internal and external audits. We seek candidates with strong project management skills, extensive experience in medical devices, and a deep understanding of quality systems. A minimum of 12 years of relevant experience is required for this pivotal role. #J-18808-Ljbffr Biogen, Inc.
$10k
## Head of Quality, Device and Combination ProductsApplyremote type: Hybridlocations: Cambridge, MAtime type: Full timeposted... ...of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices...SuggestedTemporary workLocal area$184k - $253k
About This Role As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product... ..., and external audits of CMOs. Support combination product and device implementations in asset strategy. Who You Are You are...SuggestedTemporary workWork at officeLocal area- ...and compliance best practices across products within a modality. Review major regulatory... ...of Annual Product Review/Product Quality Review and trend monitoring. Support... ...and external audits of CMOs. Support combination product and device implementations in asset strategy. Requirements...Suggested
$133.8k - $200.6k
...DescriptionGeneral SummaryThe Operational Area Quality Senior Manager provides quality... ...operations supporting medical device and combination products. The role is responsible for quality... ...HybridCompany InformationVertex is a global biotechnology company that invests in...SuggestedFull timeContract workSummer workRemote workFlexible hours2 days per week$113.6k - $181.6k
...As a Manager in Global Quality Intelligence & Product Quality Complaints, you will be responsible for establishing, implementing, and continuously... ...of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a...SuggestedHourly payRemote work- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic team responsible for all product quality aspects within Biogen’s biologics portfolio. The role encompasses strategic, tactical, and operational management within the Product Development...
- Biogen, Inc. is seeking a Head of Global Product Quality for Biologics to lead the PDQ team and drive strategy, governance, and quality across the portfolio. The role emphasizes regulatory alignment, audits, and continuous improvement across an international matrix. Hybrid...
$205k - $327.6k
Job TitleHead of Quality, Ambulatory Monitoring & DiagnosticsJob... ...& DiagnosticsThe Head of Quality, Ambulatory Monitoring... ...FDA-regulated medical devices, EU MDR, and other applicable global regulatory requirements... ...and deliver high-quality products and experiences to...Full timeWork at officeImmediate startWork visa3 days per week$200k - $245k
...daily lives.WHOOP is seeking a Director of Product Quality to lead the strategy, execution, and... ...environments.Experience working with global suppliers and contract manufacturing partners... ..., we view total compensation as the combination of base salary, equity, and benefits,...Full timeContract workWork at officeRelocation$94.6k - $141.8k
...Associate Director, GMP Operational Quality Assurance is a Quality leader... ...align with patient safety, product quality, regulatory... ...of the Vertex Biologics and Devices Quality Team, influencing cross... ...pharmaceutical setting, including global GMP manufacturing...Full timeContract workSummer workRemote workFlexible hours2 days per week- Role: Head of Quality Location: Cambridge, MA - in-person strongly preferred About Lambda Surgical... ...of the operative field. Our first product, LambdaGuide, is a LiDAR-based spatial... ...install, service, and document medical devices in a disciplined and audit-ready way....
$275k - $315k
...built using the company’s industry‑leading product engine for the development of therapies... ...at commercial launch scale. Title Head of Quality (Vice President) Location Cambridge, MA... ...clinical trial and product compliance globally by managing and improving existing quality...Contract workTemporary work$177k - $278.08k
...Join us in leading the future of Quality Control. In this role, you... ...to work with multifunctional, global teams in a fast-paced settingGood... ...rely on us to deliver quality products. As a result, we must follow... ...protective clothing over the head, face, hands, feet and body. This...Minimum wageTemporary workLocal areaShift work- Biogen in Cambridge, MA seeks a senior regulatory strategy leader to drive asset strategy and ensure GMP/GCP compliance across modalities. The role involves shaping regulatory submissions, coordinating cross-functional teams, and mentoring staff to enable agile growth. ...
$245k - $335k
...diseases that have high unmet need. As a global leader in the biology of the... ...motivated Senior Director of Global Quality Control. Reporting to the Head of Global Quality, this position is... ...partners supporting drug substance, drug product, raw materials, in-process, release,...Contract work- ...solutions for demanding medical device, biotech and... ...efficient scale-up, a consistent, quality supply, or any combination thereof. Their experienced... ...delivering value to customers globally through a strong set of... ...requirements of new products/programs as well as ensuring...Work at officeFlexible hours
- ...collaborative, and experienced VP/SVP, Head of Quality to lead the Company's Quality... ...partners while maintaining compliance with global regulatory requirements. Beyond functional... ...is integrated into every stage of product development and manufacturing. The successful...Contract work
$232k - $285k
Soufflé Therapeutics | Head of Quality Control | Job Description Soufflé Therapeutics is a biotech company focusing on the cell-type specific... ...expectations. Support QC sections of regulatory submissions. Product Quality & Release Oversee external testing and release of mAb...Work at office$200k - $217k
...experienced, strategic, and hands-on Associate Director, GMP Quality Drug Product to serve as the end-to-end quality owner for drug product... ...time, this individual will strengthen quality systems, support global regulatory inspections and submissions, drive continuous...Full timeContract workFor contractors$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered with a... ...discipline with 7 years of relevant experience, or an equivalent combination of education and work experience, preferably within the...Work experience placementRemote workWorldwideShift work$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality... ...is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills &...Full timeTemporary workLocal area$175k - $225k
...to better patient outcomes, improved quality of care, and reduced healthcare... ...novel, machine learning powered SaMD product is developed, cleared globally and evolves over its lifecycle, partnering... ...Affairs experience in the medical device industry and 2-5+ years of people...Work at officeLocal area$137.8k - $206.8k
...Senior Manager, Clinical Study Quality Lead provides study-level... ...(GCP), applicable global regulations, study protocols... ...trials, or the equivalent combination of education and experience... ...Skills:Experience supporting devices, combination products, or cell and gene therapy...Full timeSummer workRemote workFlexible hours2 days per week$102.48k - $163.97k
Job Title Software Design Quality Engineer Job Description The Software... ...pre- and post-market medical device software. Conducts detailed... ..., and performance. Assess products and systems to identify defects... ...of documentation for global registrations to enable timely...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$177k - $278.08k
Job Description About the Role As the Director, Head of Quality Operations, you will play a pivotal leadership role in shaping the future... ...effectiveness, operational excellence, and business performance across a global organization. In this highly visible role, you will lead...Minimum wageFull timeTemporary workLocal area$181k - $288k
Job TitleDirector, Quality & Regulatory- Mergers & Acquisitions (M&A... ...define ownership of QMS processes, product quality, and regulatory... ...data monitoring, and support to global market organizations.Support financial... ...FDA regulated global medical device environments (Class III...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$220k - $300k
...Nova Biomedical: One Global Brand. One Vision. Together... ...to our customers. By combining our strengths, we're accelerating... ...is seeking a Senior Quality Director , to lead... ...plans related to product development and new project... ...in the medical device or diagnostic industry....Hourly payWork at officeFlexible hours- ...Nanobiosym is looking for a Quality Manager for its High-Complexity... ...CLIA, FDA and other global regulatory authorities.Position... ...regulatory submissions for all new products and modifications to existing... ...regulatory bodies. Medical device and/or invitro diagnostics industry...Immediate start
- ...QMS Program Manager, Medical Devices, to own oversight of the QMS... ...medical devices. This role ensures quality and safety from concept... ...market while enabling fast-paced product development. You will... ...strategy into execution and support global market expansion. #J-18808-...
$225k - $337.5k
...will be responsible forGlobal Head of Alpha & Middle Office Conversions... ...commitment to execution.Own global delivery of Back‑office Client... ...while maintaining service quality, resilience, and compliance.Build... ...connector across CIE, Product Implementation, Change Management...Full timeTemporary workWork at officeFlexible hours
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