Senior RDQA Lead - Drug & 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

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