Sr Principal RDQA - Drug and Combination Product Development

Job description

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. Lead and/or QA-oversee change controls for critical GxP processes/systems within Project and R&D scope. Facilitate root cause analysis (e.g., 5-Whys, Fishbone) and drive effective CAPAs with measurable outcomes. Vendor & CRO/CDMO Quality Oversight Support vendor qualification, quality agreements, audits, and ongoing performance/issue management for CROs, CDMO’s, labs, and development partners. Metrics, Reporting & Communication Assist in definition and reporting of leading and lagging quality indicators and provide clear, concise updates to program governance, QA leadership, and cross-functional stakeholders. WHAT YOU’LL BRING TO ALCON: Bachelor’s degree in life sciences or a related field or equivalent years of directly related experience (or high school+15 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs) The ability to fluently read, write, understand and communicate in English 7 years of relevant experience Location: Onsite Travel Requirements: 10-20% Relocation Assistance: NONE Sponsorship Available: NO PREFERRED: Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP); for devices or combination products, experience of full lifecycle design controls. Understanding and experience of global product development and manufacturing regulations and how these are translated to R&D activities. Certifications: ASQ (CQE/CQA), RAPS, Lean Six Sigma Green/Black Belt. Experience with CRO/CMO/Lab oversight and GxP computerized systems (e.g., LIMS, eQMS). Familiarity with AI/ML in R&D and associated GxP data governance (optional but valuable). HOW YOU CAN THRIVE AT ALCON: Collaborate with teammates to share standard processes and learnings as work evolves! Join Alcon’s mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives. Grow your career in a highly collaborative and diverse environment. Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more! Alcon Careers See your impact at alcon.com/careers ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.