Jobs / United States / Generate Biomedicines INC
Senior Director, GMP Quality
Generate Biomedicines INC · 🇺🇸 Somerville, MA
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 14 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Generate Biomedicines INC paid sponsored hires in similar roles1 certified filing for “Associate Director, Statistical Programming” (Data Scientists) in CA: $195k–$195k, median $195k. Most were filed at wage level IV (100%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Generate Biomedicines INC
The US Department of Labor certified 14 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 2 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Generate Biomedicines INC →
About the role
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality. Here's how you will contribute: • Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments. • Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management. • Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives. • Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners. • Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation. • Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities. • Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities. • Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events. • Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards. • Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions. • Establish and monitor Quality performance indicators, identify evolving regulations and industry practices. Leadership Qualities: • Brings deep GMP, GLP, manufacturing, and regulatory expertise with sound judgment, business partnership, and strong people leadership. • Sets a clear Quality vision while remaining engaged in critical operational issues and making timely, well-reasoned decisions. • Identifies and prioritizes compliance and product risks, maintaining Quality’s objectivity and challenging decisions when patient safety, data integrity, or regulatory compliance may be compromised. • Provides practical, timely, and science-based guidance that enables development progress while protecting product quality, participant saf