Cambridge, Massachusetts, United States · Hybrid
$184k–$253k/yr
About This Role: As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects within Biogen’s biologics portfolio. Your role will encompass stra…
Skills: Biologics Quality Management, People Management, Project Management, GMP Compliance, Regulatory Submissions
Cambridge, Massachusetts, United States · On-site
$63k–$140k/yr
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful a…
Skills: Tissue Engineering, Cell Culture, Micro-physiological Systems, Organ-on-Chip, Immunology
Cambridge, Massachusetts, United States · On-site
$194k–$306k/yr
Job Description We are on a quest for cures and are committed to be the world’s premier, most research-intensive biopharmaceutical company. Our teams combine leading drug discovery capabilities and world-class R&D with t…
Skills: Antibody Drug Conjugates, Biodesign, Gene Cloning, Gene Expression Analysis, Immunochemistry
Cambridge, Massachusetts, United States · Hybrid
$169k–$266k/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Scientific Communications Strategy, Medical Publications, Project Management, Vendor Management, Oncology
Cambridge, Massachusetts, United States · Hybrid
$160k–$328k/yr
Band Level 5 Job Description Summary The Team Leader in Data Science, Disease Area X at Novartis will lead and contribute to high-impact data science programs that transform complex biological, translational, and multi-o…
Skills: Artificial Intelligence, Biostatistics, Data Governance, Data Science, Deep Learning
Cambridge, Massachusetts, United States · On-site
$58k–$107k/yr
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Skills: Spatial Transcriptomics, Bioinformatics, CRISPR Engineering, Human iPSC-based Functional Assays, Single-cell Genomics
Cambridge, Massachusetts, United States · Hybrid
$94k–$152k/yr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Solution Architecture, Technical Leadership, Data Engineering, Cloud Platforms, AI/ML
Cambridge, Massachusetts, United States · Hybrid
$169k–$266k/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Scientific Communications Strategy, Medical Publications Planning, Vendor Management, Project Management, Budget Planning
Cambridge, Massachusetts, United States · On-site
$90k–$118k/yr
Site: The Spaulding Rehabilitation Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance…
Skills: Physical Therapy Treatment, Patient Evaluation, Treatment Planning, Supervision of PTAs, Case Management
Cambridge, Massachusetts, United States · On-site
Eka Robotics Eka Robotics is on a mission to build intelligence for the physical world - robots that are fast, general, and reliable. Our approach, grounded in physics, unlocks superhuman capabilities. We are defining th…
Skills: Electrical Engineering, Firmware Development, Power Electronics, C, C++
Cambridge, Massachusetts, United States · On-site
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice an…
Skills: Medical Governance, Evidence Generation Operations, Compliance Leadership, Risk Management, GxP Oversight
Cambridge, Massachusetts, United States · On-site
$58k–$107k/yr
Band Level 3 Job Description Summary We are excited to invite applications for the Novartis Biomedical Research Postdoctoral Fellowship Program, a unique training opportunity designed for exceptional early-career scienti…
Skills: Spatial Transcriptomics, Bioinformatics, CRISPR Engineering, Human iPSC-based Functional Assays, Single-cell Genomics
Cambridge, Massachusetts, United States · On-site
$80k–$100k/yr
Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neur…
Skills: Bioanalytical Assay Development, Pharmacokinetic Assays, Immunogenicity Assays, Biomarker Assays, ELISA
Cambridge, Massachusetts, United States · Hybrid
$70k–$72k/yr
Site: The Spaulding Rehabilitation Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance…
Skills: Human Physiology, Biomedical Engineering, Optical Imaging, Signal Processing, Quantitative Analysis
Cambridge, Massachusetts, United States · Hybrid
$210k–$284k/yr
Overview: Reporting to the VP, Global Market Access, the candidate will act as the overall lead for global pricing & market access strategy for Alnylam’s Rare Disease portfolio, as well as for selected pipeline assets, b…
Skills: Global Pricing Strategy, Market Access Strategy, Payer Segmentation, Value Proposition Development, Health Economics
Cambridge, Massachusetts, United States · On-site
$57k–$74k/yr
Who are we? About LabCentral: Founded in the heart of Kendall Square in 2013, LabCentral is a network of shared laboratory spaces and scientific communities that serve as a launchpad for high-potential life-sciences and …
Skills: Account Management, Laboratory Workflows, Scientific Communication, Relationship Building, Technical Assessment
Cambridge, Massachusetts, United States · On-site
$50k–$56k/yr
Who are we? About LabCentral Founded in the heart of Kendall Square in 2013, LabCentral is a network of shared laboratory spaces and scientific communities that serve as a launchpad for high-potential life-sciences and b…
Skills: Laboratory Operations, Customer Service, Equipment Troubleshooting, Lab Safety, BSL1/BSL2 Environment
Cambridge, Massachusetts, United States · On-site
$139k–$199k/yr
Position Summary The Associate Director, Human Resources Business Partner (HRBP) serves as a trusted advisor to leaders across Research and General & Administrative (G&A) functions, partnering to build high-performing te…
Skills: HR Business Partnership, Performance Management, Talent Management, Organizational Design, Employee Relations
Cambridge, Massachusetts, United States · Hybrid
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
Skills: Fellowship Management, Operations Management, Salesforce, Marketing Cloud, Iwave
Cambridge, Massachusetts, United States · Hybrid
PhaseV is transforming clinical development through advanced AI and ML. With rapidly growing demand from top pharma, biotech companies, and CROs, we’re seeking a Senior Director of Business Development to help support an…
Skills: Enterprise Business Development, Strategic Partnerships, Contract Negotiation, Clinical Development Workflows, Stakeholder Alignment
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Lead the global product quality strategy for the biologics portfolio, ensuring alignment with GMP guidelines and company policies. Manage a team to oversee regulatory submissions, product specifications, and compliance across the product lifecycle.
Requires a Bachelor's degree and 12+ years of pharmaceutical experience, including 7 years in quality and 5 years in people management. Must possess extensive knowledge of GMP, GCP, GDP, and ICH regulations within an international matrix environment.
As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects within Biogen’s biologics portfolio. Your role will encompass strategic, tactical, and operational management within the Product Development Quality (PDQ) department, ensuring that all quality-related aspects align with Biogen’s policies and GMP guidelines. You will facilitate the execution of activities between business partners, the CMC Asset Team, and the Quality organization, while empowering your team to drive innovation and best practices. Your leadership will ensure alignment across the portfolio, leveraging adjacent experience to lead teams on existing and new products and technologies. This pivotal position not only guarantees quality compliance but also develops the capabilities of your direct reports and broader organization in team management and quality issues. Your contribution is vital to maintaining our commitment to product excellence and innovation.
This is a hybrid role based either at our office in Research Triangle Park, NC or Cambridge, MA.
Lead asset strategy and compliance best practices across products within a modality.
Review major regulatory submissions and help set up regulatory strategic plans.
Develop and cross-train staff for maximum flexibility and growth.
Execute specification strategy for regulatory submissions and address agency concerns.
Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
Represent Biogen at external forums to stay abreast of emerging expectations and trends.
Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
Support internal audits, certifications, and external audits of CMOs.
Support combination product and device implementations in asset strategy.
You are an inspiring leader with a passion for quality and excellence in biologics. Your ability to empower and develop your team sets you apart as a mentor and coach. You thrive in collaborative environments, seamlessly integrating strategic vision with operational execution. Your innovative mindset drives you to tackle complex challenges, finding solutions that enhance product quality and compliance. You are adept at navigating cross-organizational relationships, influencing stakeholders, and fostering a culture of continuous improvement.
Bachelor’s degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
Minimum of 5 years of experience in people management and project management.
Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
Experience in an international matrix environment.
Technical expertise in manufacturing, testing, or technical development.
Strong written and verbal communication skills.
Ability to influence partners and stakeholders with strong negotiation skills.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
Based on 729 listings with disclosed salaries, most science & research jobs in Cambridge, MA pay between $90k–$269k per year. Individual offers vary with seniority, company size, and specialization.
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