Product Quality Lead — GxP, Compliance & Submissions

100 Eli Lilly and Company; United States; Remote; USD 117,000 - 189,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director, Product Quality in the US. You will lead QA for development and partnerships, balancing compliance with speed to deliver medicines.

You will own QMS design, oversee regulatory submissions (INDs/CTAs/NDAs), and mentor a small QA team, with travel up to 20% as needed. This role emphasizes strategic thinking and hands-on execution.

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8+ years in pharmaceutical quality roles with 3+ years in leadership.
• Strong knowledge of FDA, EMA, ICH GxP requirements.
• Experience with document control software (ZenQMS, Veeva Vault, MasterControl).

Responsibilities

• Design, implement, and scale a Quality Management System (QMS) for development and pipeline.
• Provide GxP compliance oversight for internal functions and outsourced partners.
• Lead QA activities: deviations, CAPAs, change control, document control, training.
• Serve as quality lead for regulatory submissions (INDs, CTAs, NDAs) and material release.
• Prepare for regulatory inspections and audits; interact with health authorities.

Skills

Leadership

GxP knowledge

Regulatory knowledge

Cross-functional collaboration

Quality system development

Education

BS or higher in Life Sciences, Chemistry, Pharmacy, or related field

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly, is seeking an Associate Director, Product Quality in the US. You will lead QA for development and partnerships, balancing compliance with speed to deliver medicines.

You will own QMS design, oversee regulatory submissions (INDs/CTAs/NDAs), and mentor a small QA team, with travel up to 20% as needed. This role emphasizes strategic thinking and hands-on execution.