Remote GMP QA Senior Director - Quality Leader

Tyra Biosciences, Inc.; United States; Remote; USD 290,000 - 318,000; Full time

Benefits offered by this job

Competitive base salary + bonus

Equity grant

Medical, dental, vision insurance

401(k) with company match

Paid holidays and vacation

Tuition assistance

Job summary

Tyra Biosciences, Inc. seeks an experienced Senior Director of GMP Quality Assurance to lead outsourced sponsor quality activities across clinical and commercial programs.

This hands-on leader will build the GMP QA function, own batch disposition, oversee regulatory inspections, and drive readiness for NDA submissions in a dynamic, cross-functional environment. The role requires extensive CDMO oversight, 21 CFR/Q7–Q12 knowledge, and a proven track record in NDA submissions and

Qualifications

• 15+ years of pharmaceutical GMP Quality Assurance experience.
• 8+ years in a people leadership role and building GMP QA functions.
• Experience overseeing outsourced manufacturing for small molecules and solid oral dose products.
• Direct involvement in NDA submissions and PPQ campaigns.
• Strong knowledge of 21 CFR Parts 11, 210, 211, EU GMP, ICH Q7–Q12 and GDP

Responsibilities

• Develop and execute GMP QA strategy aligned with Global Quality vision for clinical supply, NDA submissions, and commercial launch.
• Build and lead a high-performing GMP QA team and manage the budget.
• Serve as GMP QA representative on CMC, Supply Chain, and program teams; advise on regulatory requirements.
• Provide QA oversight of CDMOs, labs, and packagers; maintain QA-to-QA relationships.
• Review batch records, deviations, investigations, and change controls; ensure robust CAPA.
• Author and approve Quality Agreements with CDMOs and GMP vendors.
• Oversee technology transfer, validation, stability, and PPQ activities for NDA readiness.
• Own batch disposition and QP certification processes with external QPs.
• Oversee distribution practices, serialization, and DSCSA readiness.
• Lead supplier qualification and audit programs with Quality Systems; support inspections.
• Prepare for FDA PAI and health authority inspections; support regulatory submissions quality sections.
• Develop and approve GMP/GDP SOPs; report metrics to Management Review and senior leadership.

Skills

GMP Quality Assurance

CDMO oversight

Regulatory inspections

eQMS (Veeva/MasterControl/TrackWise)

Quality systems

Education

Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related

Tools

Veeva Vault

MasterControl

TrackWise

Job description

Tyra Biosciences, Inc. seeks an experienced Senior Director of GMP Quality Assurance to lead outsourced sponsor quality activities across clinical and commercial programs.

This hands-on leader will build the GMP QA function, own batch disposition, oversee regulatory inspections, and drive readiness for NDA submissions in a dynamic, cross-functional environment. The role requires extensive CDMO oversight, 21 CFR/Q7–Q12 knowledge, and a proven track record in NDA submissions and