Jobs / United States / Astrazeneca Pharmaceuticals Lp
Director Product Quality Leader
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US – Santa Monica Colorado Avenue – CA
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 99 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 31 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 Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles4 certified filings for “Director, R&D IT - Dvlpmt & Late TA, IT Product Mgmt Clinic” (Data Scientists) in MD: $194k–$201k, median $194k. Most were filed at wage level IV (75%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Last confirmed live 2 days agoWhen 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 — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 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 31 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 Astrazeneca Pharmaceuticals Lp →
About the role
The Cell Therapy Product Quality Leader (PQL) is a matrixed leader responsible for the end-to-end product quality strategy and lifecycle management of autologous, allogeneic, and in-vivo cell therapy products. This role will provide technical and compliance oversight for advanced therapeutic modalities, including, but not limited to, drug substance, drug product, viral delivery systems ( e.g. LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. This role requires deep technical and compliance expertise , strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained . This PQL position can physically reside at either the Gaithersburg/Rockville, MD site or Santa Monica/Tarzana, CA site locations, with an understanding that the products supported are manufactured at the Santa Monica/Tarzana, CA sites. Main Responsibilities : • Serve as the Quality representative on the CMC T eam and lea d the Product Quality Team (PQT) sub-team • Serve as the single voice of Quality in liaising with the CMC Program Lead to communicate Quality deliverables, risks, changes, etc. • D evelop and implement the overall Product Quality Strategy and phase-appropriate control strategies • Own and maintain lot release and stability specifications for advanced cell therapy modalities • Manage the full specification lifecycle - from clinical stage through commercial approval and post-approval maintenance • Support the design and execution of analytical comparability studies supporting process and product changes for advanced cell therapy modalities; ensure scientifically sound strategies and data-driven conclusions • Support the design and execution of process tech transfer and analytical method transfer protocols/reports for advanced cell therapy modalities • Oversee the stability program for advanced cell therapy modalities, in collaboration with Global Stability • Oversee annual product reviews for commercial products • Maintain the Product Quality Risk Register to identify , mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain • Work cross-functionally to d evelop and implement platform approaches for specifications, comparability, and stability to enable consistent, scalable practices across multiple cell therapy products • Author and review CMC sections for global filings, including INDs, BLAs, and MAAs; manage responses to health authority queries • Stay current on emerging process & analytical technologies and evolving regulatory expectations • Partner closely with Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory Affairs, Program Management, and other impacted stakeholders to ensure alignment with development milestones and commercial objectives • Acts as a Subject Matter Expert (SME) during health authority inspections (e.g., FDA, EMA) for product quality -specific inquiries • Review and evaluate major process changes to ensure no impact to product safety and efficacy Education, Qualifications, & Experience : • Bachelor’s or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering) • 10+ years in the biotech nology or biopharmaceutical industry, with at least 3 - 5 years in a Cell & Gene Therapy (CGT) or B iologics leadership role • Deep understanding of global cGMP regulations (FDA, EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products • Demonstrated record of authoring CTD sections for IND, BLA/MAA,