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 + 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. 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.

Job 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

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.

Pay Range and Benefits

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.

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

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote

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

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.