Alcon Research
Sr Principal RDQA - Drug and Combination Product Development
Fort Worth, Texas · Principal · Contract
Sponsorship not specified$10k-$20kDetected 5 days ago
GCPMachine LearningComplianceProcess ImprovementGMPFDA RegulatoryMedical DevicesAnimal StudiesLeadershipCommunicationProblem SolvingLean ManufacturingGxP
About the role
- 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.
- 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.
Responsibilities
- 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.
- Develop and implement initiatives which accelerate innovation and sustainable project excellence.
- Create and maintain Quality Project Plans, Risk Registers, and other project related tasks aligned to phase of development.
- 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.
- Support vendor qualification, quality agreements, audits, and ongoing performance/issue management for CROs, CDMO's, labs, and development partners.
- Collaborate with teammates to share standard processes and learnings as work evolves!
Requirements
- 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).
Nice to have
- Experience in biotech/pharma technical/CMC development and clinical product manufacturing (GMP) and/or clinical/preclinical development (GCP/GLP)
- Understanding and experience of global product development and manufacturing regulations and how these are translated to R&D activities.
Compensation
- $10k-$20k
Visa & Work Authorization
- Sponsorship Available: NO
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