Director, GMP Quality Assurance Operations

Tyra Biosciences, Inc. is seeking a highly motivated Director, GMP Quality Assurance Operations 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, detail-oriented quality professional who thrives in a dynamic, cross-functional, and fully outsourced sponsor environment.

The Director is responsible for day-to-day quality oversight of externally manufactured drug substance and solid oral dose drug product. Serving as the primary QA contact for assigned CDMOs and programs, this role executes the GMP and GDP quality strategy defined by the Senior Director, GMP Quality Assurance, ensuring timely, compliant release of clinical supplies and building the foundation for commercial readiness.

Job Responsibilities:

• Serve as the primary QA contact for assigned CDMOs, contract testing laboratories, and packagers, escalating issues to the Senior Director as appropriate.
• Review and approve batch records, deviations, investigations, out-of-specification results, and change controls, ensuring robust root cause analysis, product impact assessment, and effective CAPA.
• Review and approve specifications, certificates of analysis, analytical methods, protocols, and reports supporting GMP manufacturing and testing.
• Provide quality support for technology transfer, validation, stability, and Process Performance Qualification (PPQ) activities, including person-in-plant support at CDMOs as needed.
• Execute batch disposition of drug substance, drug product, and clinical supplies, coordinating with Supply Chain on release timelines and with external Qualified Persons (QPs) as needed.
• Provide day-to-day Good Distribution Practices oversight of storage and logistics providers, including disposition of temperature excursions and support of product quality complaints.
• Plan, conduct, and report GMP and GDP supplier audits, track supplier CAPA through closure, and provide input to Quality Agreements.
• Support inspection readiness for FDA Pre-Approval Inspections and verification of quality sections of regulatory submissions (e.g., NDA Module 3).
• Author and revise GMP and GDP Standard Operating Procedures and ensure quality records are accurately managed within the eQMS.
• Track and trend GMP and supplier quality metrics and identify process improvements for GMP QA operations.

Qualifications: Required

• Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or a related discipline and 10+ years of pharmaceutical GMP Quality Assurance experience.
• Hands-on experience overseeing outsourced small molecule drug substance and solid oral dose drug product manufacturing through CDMOs, preferably in a sponsor company environment.
• Demonstrated experience with batch record review, batch disposition, deviation and investigation management, and change control.
• Working knowledge of 21 CFR Parts 11, 210, and 211, EU GMP, ICH Q7, Q9, and Q10, and Good Distribution Practices.
• Experience conducting supplier audits, supporting regulatory inspections, and using an electronic Quality Management System (e.g., Veeva Vault, MasterControl, TrackWise).
• Strong communication, risk-based decision-making, and organizational skills, with the ability to manage multiple programs independently 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 late-stage clinical programs, PPQ campaigns, and FDA Pre-Approval Inspections.
• Experience with QP release, distribution quality, serialization, and DSCSA compliance.

Pay Range and Benefits: Base Salary Range: $217,425 - $230,640 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.

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.