Senior Director - GMP Quality Assurance

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.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.