Acadia Pharmaceuticals Inc.
Sr. Director of Value, Access and Policy, Europe(m/w/x)
Vollzeitnur vor OrtSenior
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SCScholar Rock
Sr. Director, Commercial Quality / Market Quality(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Building a scalable commercial quality function for apitegromab, ensuring compliant market release and patient supply. 15+ years of biotech/pharma quality experience required. Oversight of external manufacturing, packaging, labeling, and distribution.
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Anforderungen
- BS/BA degree in scientific or engineering discipline
- 15+ years progressive Quality experience in biotech/pharma
- Significant leadership of commercial quality
- Oversight of external manufacturing, packaging/labeling, testing, distribution
- People leadership strongly preferred
- Expertise with marketed product quality systems
- Commercial batch release/market disposition knowledge
- Product status control knowledge
- Complaint handling knowledge
- Quality risk management knowledge
- Strong working knowledge of European and Swissmedic regulations
- Experience representing Quality in health authority inspections
- Hands-on experience in EU/EEA commercial release model
- Governance of QP certification activities
- Governance of batch certification packages
- Prior direct QP qualification is a plus
- Experience establishing post-market product monitoring
- Experience governing post-market product monitoring
- Complaint trending experience
- Signal detection interfaces with Pharmacovigilance/Medical experience
- Management review/KPIs experience
- Continuous improvement experience
- Proven experience leading recalls/field actions
- Decision-making for recalls/field actions
- Health authority notifications support for recalls
- Cross-functional execution of recalls/field actions
- Effectiveness checks for recalls/field actions
- Experience conducting mock recalls preferred
- Ability to lead through influence in matrixed organization
- Drive effective governance across external partners
- Strong executive presence
- Strong communication skills
- Sound risk-based judgment
- Ability to balance strategic leadership with compliant quality decision-making
- Highly proactive
- Decisive
- Capable of independently driving complex cross-functional initiatives
- Experience scaling commercial quality for European launch
- Experience scaling commercial quality for ex-U.S./ROW expansion
- Experience with GDP networks and QP release models preferred
Aufgaben
- Build and lead a scalable Commercial Quality function
- Establish clear separation between manufacturing and commercial control
- Create a dedicated Market Release Authorization vertical
- Ensure compliant disposition for each market and reliable patient supply
- Account for EU/EEA-aligned commercial quality governance
- Oversee QP certification and market release readiness
- Establish authority to place and lift commercial holds
- Create robust post-market controls meeting FDA and European/Swiss expectations
- Ensure compliant product release, complaint handling, and quality risk management
- Provide senior leadership for Commercial Quality
- Ensure patient-focused and compliant oversight of marketed products
- Establish and own the Market Release Authorization vertical
- Distinguish manufacturing batch disposition from commercial/market disposition
- Serve as the end-to-end Quality leader for commercial operations
- Partner with Supply Chain, Distribution/Logistics, Labeling, Regulatory, Pharmacovigilance, and Manufacturing/CMOs
- Hold decision rights to place and lift commercial holds
- Ensure clear governance, escalation pathways, and documentation
- Own and continuously improve the post-market quality system
- Support global regulatory commitments
- Lead commercial product release/disposition governance
- Oversee product status control and release documentation
- Ensure country-specific release requirements
- Govern batch certification packages and quality decision escalation pathways
- Provide Quality oversight for distribution and logistics
- Ensure EU GDP expectations and temperature-controlled processes
- Manage lane qualification, distribution excursions/investigations, returns/destruction
- Oversee 3PLs and other service providers through quality agreements and metrics
- Lead commercial Quality inspection readiness and external interactions
- Ensure sustained compliance across the commercial supply chain
- Lead and execute recall and field action readiness and response
- Partner with PV/Medical/Regulatory and Supply Chain for timely decisions
- Ensure effective communications and compliant execution
- Oversee quality impact assessment for changes affecting marketed products
- Ensure alignment with filings/commitments and market release requirements
- Provide governance for commercial packaging and labeling quality
- Partner with Regulatory Labeling for compliant implementation
- Ensure compliance with serialization/traceability requirements
- Maintain robust product security controls
Berufserfahrung
15 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
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SC
PharmaceuticalsZug
The company discovers, develops, and delivers life-changing therapies for serious diseases with high unmet need.
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