Senior Director, GMP Quality Assurance

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

POSITION OVERVIEW

Tyra Biosciences, Inc. is seeking an experienced and highly motivated Senior Director, GMP Quality Assurance to make impactful contributions to oncology and rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be a hands‑on quality leader who thrives in a dynamic, cross‑functional, and fully outsourced sponsor environment.

The Senior Director is accountable for quality oversight of all externally manufactured drug substance and solid oral dose drug product, from regulatory starting materials through release and distribution. This role will build and lead the GMP QA function, own batch disposition, and drive inspection readiness as Tyra advances toward NDA submissions and commercial readiness.

KEY RESPONSIBILITIES

• Develop and execute the GMP Quality Assurance strategy in alignment with the Global Quality vision and company objectives for clinical supply, NDA submissions, and commercial launch.
• Build and lead a high‑performing GMP QA team, scaling internal and outsourced resources in a phase‑appropriate manner, and manage the GMP QA budget.
• Serve as the GMP Quality representative on CMC, Supply Chain, and program teams, providing guidance on FDA, EMA, MHRA, and ICH requirements.
• Provide quality oversight of CDMOs, contract testing laboratories, and packagers, maintaining strong QA‑to‑QA relationships.
• Review and approve batch records, deviations, investigations, out‑of‑specification results, and change controls, ensuring robust root cause analysis and effective CAPA.
• Author, negotiate, and approve Quality Agreements with CDMOs and GMP vendors.
• Provide quality oversight of technology transfer, validation, stability, and Process Performance Qualification (PPQ) activities in preparation for NDA submissions.
• Own batch disposition of drug substance, drug product, and clinical supplies, including Qualified Person (QP) certification processes with external QPs.
• Oversee Good Distribution Practices for storage and distribution, including temperature excursions, complaints, recalls, and commercial readiness for serialization and DSCSA.
• Lead the risk‑based GMP and GDP supplier qualification and audit program in collaboration with Quality Systems.
• Lead inspection readiness for FDA Pre‑Approval Inspections and international health authority inspections, and support review of quality sections of regulatory submissions (e.g., NDA Module 3).
• Develop and approve GMP and GDP Standard Operating Procedures, and report GMP quality metrics at Management Review and to senior leadership.

QUALIFICATIONS & EXPERIENCE

Required

• Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or a related discipline and 15+ years of pharmaceutical GMP Quality Assurance experience, including 8+ years in a people leadership role.
• Extensive experience overseeing outsourced small molecule drug substance and solid oral dose drug product manufacturing through CDMOs in a sponsor company environment.
• Demonstrated experience supporting late‑stage programs through NDA submission, including PPQ campaigns and FDA Pre‑Approval Inspections.
• Comprehensive knowledge of 21 CFR Parts 11, 210, and 211, EU GMP, ICH Q7–Q10 and Q12, and Good Distribution Practices.
• Experience hosting regulatory inspections, conducting supplier audits, and negotiating Quality Agreements.
• Experience using an electronic Quality Management System (e.g., Veeva Vault, MasterControl, TrackWise).
• Excellent communication and risk‑based decision‑making skills, with the ability to balance strategic and tactical responsibilities in a fast‑paced biotech environment.

Preferred

• Advanced degree (M.S., Ph.D., or Pharm.D.) or professional certification (e.g., ASQ CQA or CPGP).
• Experience supporting commercial product launches, including serialization and DSCSA compliance.
• Experience establishing QP release processes and supporting global marketing authorization applications.
• Experience in oncology or precision medicine programs.

TRAVEL

• Up to 30% domestic and international travel to CDMOs, suppliers, and distribution partners

Base Salary Range: $290,469 - $317,518 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

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What we offer US‑based Employees

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full‑time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer‑paid Medical, dental, and vision insurance
• Employer‑paid life insurance, AD&D, short‑term disability, long‑term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Equal Opportunity Employer

Tyra Biosciences is an equal opportunity employer committed to building a diverse and inclusive workforce.

Employment decisions are made without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity or expression, veteran status, or any other characteristic protected by applicable federal, state, or local laws.