Sr Principal RDQA - Drug and Combination Product Development

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

The Sr Principal RDQA - Drug and Combination Product Development drives quality excellence across Pharma R&D projects by leading quality planning, risk management, and project quality oversight activities for complex, cross-functional R&D projects.

This role partners closely with Pharma R&D Project Teams and functions including Clinical, Preclinical, CMC/Technical Development, Design Control and Regulatory to embed fit-for-purpose quality approaches in product development through deployment and improvement of phase and stage appropriate quality procedures which ensure compliance to regulatory requirements and the Alcon Quality Manual.

The ideal candidate blends deep GxP/ISO expertise with strong R&D project leadership, pragmatic problem solving, and the ability to influence without authority at our R&D Facility in Fort Worth, TX. Specifics include:

Quality Leadership of R&D Projects

- Lead the quality workstream across assigned R&D programs from initiation through launch, establishing Quality Plans, and approving key product development plans and associated documents.

- Define and integrate phase-appropriate and risk-based approaches in accordance with internal procedures and regulatory guidelines.

- Develop and implement initiatives which accelerate innovation and sustainable project excellence.

Quality Planning, Risk Management and Regulatory Compliance

- Create and maintain Quality Project Plans, Risk Registers, and other project related tasks aligned to phase of development.

- Facilitate proactive risk identification (FMEA/ICH Q9/ISO 14971), communicate mitigation plans, and escalation pathways and ensure compliance with applicable regulations (e.g., ICH GxP, EMA, FDA, ISO 13485, ISO-14971, 21 CFR Part 820 for devices, and 21 CFR Part 4 for Combination Products).

QMS & Process Enablement

- Translate regulatory expectations into lean, phase-appropriate processes, SOPs/WIs, templates, and job aids; partner with Quality Systems to implement.