Head GxP Quality & Compliance

Head GxP Quality & Compliance at Windward Bio (Basel/Remote)

Build the Quality Framework Behind Breakthrough Clinical Innovation

Are you passionate about ensuring the highest standards of quality, compliance, and patient safety? Windward Bio is seeking a Head, GxP Quality Compliance to establish and lead our comprehensive Quality Management System – setting the foundation for clinical trials and therapies that will transform lives.

Windward Bio is a clinical-stage, venture-backed biotech company committed to transforming the treatment of people living with advanced immunological conditions. Led by a highly experienced team of industry executives with deep discovery, development, and commercialization expertise, we're advancing WIN
378, a potential best-in-class, long-acting monoclonal antibody for severe asthma, with plans to expand into COPD and other respiratory indications
. Currently in Phase 2 clinical trials (POLARIS), we're backed by $200M in Series A financing from top-tier investors and headquartered in Basel. We move fast and think big.

As our Head GxP Quality & Clinical Compliance, you'll act as the central quality hub across our organization. This role is primarily focused on clinical trial quality and GCP compliance, while also providing phase-appropriate oversight for CMC and GMP activities delivered through external partners.

Operating in a hub-and-spoke model, you will define quality frameworks, governance, and escalation pathways, while execution remains with functional teams and qualified external vendors. You will own and continuously improve Windward Bio’s Quality Management System, ensuring consistent and risk-based application of GxP standards as we advance our clinical programs.

Key responsibilities include:

• Clinical Trial Quality & Compliance:
  Oversee and facilitate GCP compliance across clinical sites, CROs, and partners; support trial data integrity, protocol and ICF review, monitoring strategies, and pharmacovigilance activities.
• Quality Management System:
  Own and evolve the company’s QMS and eQMS, defining core GxP procedures, training frameworks, and governance standards appropriate for a clinical-stage biotech.
• CMC & GMP Quality Oversight:
  Provide phase-appropriate quality oversight for CMC and GMP activities conducted through external partners, including batch documentation, stability programs, tech transfer readiness, and change control assessments.
• Vendor & Partner Oversight:
  Provide quality governance for outsourced GxP activities; review Quality Agreements and key quality events; support vendor qualification and risk-based performance monitoring.
• Inspections & Audits:
  Support Health Authority inspections and inspection-readiness activities, serving as the central quality point of contact.
• Cross-Functional Partnership:
  Serve as the Quality interface to Clinical Operations, CMC, Regulatory Affairs, R&D, and IT, enabling alignment and informed decision‑making.

• 8–12 years of hands‑on GxP Quality Assurance experience in biotech or pharma, with proven success in both clinical trial quality AND manufacturing oversight
• Advanced degree (MSc, Pharm
  
  D, or equivalent) in Life Sciences, Pharmacy, Chemistry, or related field
• Demonstrated GCP expertise:
  Clinical trial quality oversight, clinical site audits, clinical data integrity, or IND/CTA submissions
• Strong GMP knowledge with exposure to GLP and GVP standards
• Hands‑on eQMS experience implementing or operating systems such as PQMS, Veeva, Master Control, eQMS
  360, etc.
• Proven track record supporting both CMC AND clinical trial activities through development stages (IND, Phase 1, Phase 2, or beyond)
• Prior experience with Health Authority inspections or audits (clinical or manufacturing)
• Practical, risk‑based mindset balancing compliance with business agility in a fast‑paced environment
• Excellent communication and collaboration skills, comfortable operating independently in a lean, dynamic setting
• Fluent in English (spoken and written)

Join a mission‑driven team transforming treatment for millions living with advanced immunological conditions. You'll build something from the ground up—establishing the quality infrastructure for breakthrough therapies addressing severe asthma, COPD, and beyond. Work alongside an experienced leadership team committed to innovation, compliance excellence, and real‑world impact – headquartered in Basel, Switzerland, with a collaborative, forward‑thinking culture.

Ready to propel your career and make a genuine impact?

Apply now to help shape the quality backbone of Windward Bio’s clinical success.