Senior Director, GMP QA & NDA Readiness

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

Benefits offered by this job

Competitive base salary and bonus

New hire and ongoing equity packages

Employer-paid Medical, dental, and vis

401(k) Plan with company match

Employee Stock Purchase Plan

Paid holidays

Flexible vacation

Sick time

Tuition assistance

Job summary

Tyra Biosciences, Inc. seeks an experienced Senior Director, GMP Quality Assurance to lead the quality function in a fully outsourced sponsor environment. You will oversee QA for drug substance and solid oral dose products and drive NDA readiness and commercial readiness.

You will build a high‑performing GMP QA team, manage inspections, and ensure compliance with 21 CFR Parts 11, 210, 211, and ICH guidelines while partnering with CDMOs and internal stakeholders.

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or a related discipline.
• 15+ years of pharmaceutical GMP Quality Assurance experience, including 8+ years in a leadership role.
• Experience overseeing outsourced CDMOs for small molecule drug substance and solid oral dose products.
• Experience supporting NDA submissions and FDA Pre‑Approval Inspections.

Responsibilities

• Develop and execute the GMP Quality Assurance strategy aligned with Global Quality vision for clinical supply, NDA submissions, and commercial launch.
• Build and lead a high‑performing GMP QA team with both internal and outsourced resources; manage the budget.
• Serve as GMP QA representative on CMC, Supply Chain, and program teams; provide guidance on FDA/EMA/MHRA/ICH requirements.
• Provide quality oversight of CDMOs, contract testing labs, and packagers; maintain QA‑to‑QA relationships.
• Review and approve batch records, deviations, investigations, out‑of‑spec results, and change controls; ensure robust CAPA.

Skills

Excellent communication

Risk-based decision making

Regulatory inspections experience

Cross-functional collaboration

Education

Advanced degree (MS/PhD/PharmD) or ASQ CQA/CPGP

Tools

Veeva Vault

MasterControl

TrackWise

Job description

Tyra Biosciences, Inc. seeks an experienced Senior Director, GMP Quality Assurance to lead the quality function in a fully outsourced sponsor environment. You will oversee QA for drug substance and solid oral dose products and drive NDA readiness and commercial readiness.

You will build a high‑performing GMP QA team, manage inspections, and ensure compliance with 21 CFR Parts 11, 210, 211, and ICH guidelines while partnering with CDMOs and internal stakeholders.