Sr. Director, Commercial Quality / Market Quality

Position Responsibilities

• Provide senior leadership for Commercial Quality, ensuring patient-focused, compliant, and robust oversight of marketed product(s) and launch readiness for new indications/markets.
• Establish and own the Market Release Authorization vertical, distinguishing manufacturing batch disposition from commercial/market disposition and ensuring release decisions meet applicable market requirements (U.S., EU, and other regions as expanded).
• Serve as the end-to-end Quality leader for commercial operations, partnering with Supply Chain, Distribution/Logistics, Labeling, Regulatory, Pharmacovigilance, Medical Affairs, and Manufacturing/CMOs to enable reliable supply and compliant market execution.
• Hold decision rights to place and lift commercial holds, including for safety signals, distribution excursions, labeling issues, complaint trends, shortage mitigation, or recall-related actions; ensure clear governance, escalation pathways, and documentation.
• Own and continuously improve the post-market quality system to meet health authority expectations as per applicable guidance, and to support global regulatory commitments.
• Lead commercial product release/disposition governance, including product status control, release documentation, country-specific requirements, and oversight of release by Qualified Person (QP) (as applicable), governance of batch certification packages and escalation pathways for quality decisions.
• Provide Quality oversight for distribution and logistics, including EU GDP expectations, temperature-controlled/cold chain processes, lane qualification, distribution excursions/investigations, returns/destruction, and oversight of 3PLs and other service providers across Switzerland, EU/EEA, and other regions through quality agreements and metrics.
• Lead commercial Quality inspection readiness and external interactions, including health authority inspections, ensuring sustained compliance across the commercial supply chain.
• Lead and execute recall and field action readiness and response (including mock recalls), partnering with PV/Medical/Regulatory and Supply Chain to ensure timely decisions, effective communications, and compliant execution (including EU/UK-style Field Safety Corrective Actions where applicable).
• Oversee quality impact assessment and decision-making for changes that may affect marketed product (process, analytical, specifications, site/supplier, packaging/labeling, distribution lanes), ensuring alignment with filings/commitments and market release requirements.
• Provide governance for commercial packaging and labeling quality (artwork/label content controls, printed component release, reconciliation, tamper evidence), and partner with Regulatory Labeling to ensure compliant implementation across markets.
• Partner with Supply Chain/IT and external providers to ensure compliance with applicable serialization/traceability requirements and robust product security controls, as needed by market.

Candidate Requirements

• BS/BA degree in a scientific or engineering discipline required; advanced degree preferred
• 15+ years of progressive Quality experience in biotech/pharma (biologics preferred), including significant leadership of commercial quality and oversight of external manufacturing, packaging/labeling, testing, and distribution networks; people leadership strongly preferred
• Demonstrated expertise with marketed product quality systems, including commercial batch release/market disposition, product status control, complaint handling, and quality risk management
• Strong working knowledge of European and Swissmedic regulations and guidance applicable to commercial supply; experience representing Quality in health authority inspections (e.g., EMA member state authorities, MHRA, Swissmedic, FDA)
• Hands-on experience operating within an EU/EEA commercial release model, including governance of QP certification activities and batch certification packages; prior direct QP qualification is a plus
• Experience establishing and governing post-market product monitoring, including complaint trending and signal detection interfaces with Pharmacovigilance/Medical, management review/KPIs, and continuous improvement
• Proven experience leading recalls/field actions, including decision-making, health authority notifications support, cross-functional execution, and effectiveness checks; experience conducting mock recalls preferred
• Demonstrated ability to lead through influence in a matrixed organization and drive effective governance across external partners (e.g., quality agreements, release expectations, GDP oversight, metrics/KPIs, escalation pathways, and performance improvement)
• Strong executive presence and communication skills, sound risk-based judgment, and the ability to balance strategic leadership with timely, compliant quality decision-making 
• Highly proactive, decisive, and capable of independently driving complex cross-functional initiatives in a fast-paced environment; experience scaling commercial quality capabilities for European launch and expansion (including GDP networks and QP release models) and broader ex-U.S./ROW expansion strongly preferred