Sr Principal RDQA - Drug and Combination Product Development

Alcon; Fort Worth (TX); On-site; USD 150,000 - 195,000; Full time

Job summary

Alcon's Sr Principal RDQA role at the Fort Worth facility seeks a quality leader to drive GxP/ISO excellence across Pharma R&D projects, partnering with Clinical, CMC/Technical Development, and Regulatory to embed fit-for-purpose quality throughout development.

The successful candidate will lead quality planning, risk management, and oversight, implement lean processes, manage CAPAs, and supervise vendor/CRO quality, ensuring compliance with ICH GxP, FDA, EMA, and ISO standards while advancing

Qualifications

• Bachelor's degree in life sciences or related field or equivalent experience.
• Minimum 7 years of relevant experience in pharma/biotech quality.
• Fluent English communication (read/write/speak).
• Onsite location in Fort Worth, TX; travel 10–20%.
• Relocation not offered; Sponsorship not available.

Responsibilities

• Lead the quality workstream across R&D programs from initiation through launch, with Quality Plans and approvals.
• Define phase-appropriate and risk-based approaches in line with procedures and regulatory guidelines.
• Develop initiatives to accelerate innovation and sustainable project excellence.
• Create and maintain Quality Project Plans and Risk Registers; drive CAPAs with measurable outcomes.
• Provide vendor/CRO/CDMO quality oversight, audits, and performance management.
• Report leading/lagging quality indicators to governance and cross-functional teams.

Skills

GxP/ISO expertise

R&D project leadership

Regulatory compliance

Quality Oversight

Education

Bachelor's degree in life sciences or related field

Tools

LIMS

eQMS

CAPA tools

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

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 [e-mail] and let us know the nature of your request and your contact information.