Director, CMC Quality Assurance Full Time NEW

This is a high-impact leadership role responsible for building and scaling the CMC Quality Assurance function within a fast-growing, science-driven organization focused on advancing innovative veterinary medicines. You will play a pivotal role in ensuring that manufacturing, testing, and regulatory activities meet the highest standards of quality and compliance across the product lifecycle. Acting as the key QA authority for CMC operations, you will partner closely with regulatory, manufacturing, and supply chain teams to support clinical development and future commercialization. The role requires both strategic vision and hands-on execution, particularly in a startup environment where systems must be built from the ground up. You will oversee external manufacturing partners, ensure inspection readiness, and guide quality decisions that directly impact regulatory success. This position is ideal for an experienced QA leader who thrives in dynamic environments and is motivated by building scalable systems that support groundbreaking therapies.

Accountabilities

• Build and lead the CMC Quality Management System, including SOPs, document control, change control, deviations, CAPA, and risk management processes, ensuring scalability through clinical and commercial stages.
• Serve as the primary QA interface for CDMOs, contract labs, and suppliers, overseeing qualification, audits, quality agreements, and ongoing performance management.
• Lead GMP audit execution, manage findings, and ensure timely CAPA closure across external partners and internal systems.
• Oversee batch disposition activities, ensuring complete, audit-ready documentation and timely release of clinical and development batches.
• Review and approve critical CMC documentation including validation protocols, stability data, batch records, and certificates of analysis.
• Manage deviation and OOS investigations originating from external partners through resolution and compliance closure.
• Lead PAI readiness activities and act as QA lead during FDA inspections and regulatory interactions related to CMC.
• Support regulatory submissions and technical transfers in collaboration with CMC and Regulatory Affairs teams.
• Define and track CMC QA KPIs to monitor CDMO performance, CAPA timelines, audit outcomes, and batch release efficiency.
• Ensure quality oversight of tech transfer activities, including site qualification, comparability studies, and batch record development.
• Own Annual Product Review processes and QA approval of labeling for clinical and commercial supply.
• Build quality systems supporting transition from clinical development to commercial manufacturing, including post-approval change management frameworks.

Requirements

• Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or related field, with advanced degree preferred.
• 15+ years of pharmaceutical or biotech industry experience in Quality Assurance, including senior CMC QA leadership roles.
• Proven experience building CMC quality systems from early development through NDA/BLA submission and approval.
• Strong hands-on experience managing CDMOs and contract labs, including audits, quality agreements, and batch release oversight.
• Deep knowledge of FDA GMP regulations (21 CFR 210/211), ICH/VICH guidelines, and quality risk management principles.
• Experience leading or supporting PAI preparation and FDA inspections.
• Background in small molecule oral solid dosage forms is required.
• Experience with commercial batch release and post-approval change management strongly preferred.
• Strong ability to operate in lean, fast-paced environments with limited infrastructure.
• Excellent communication skills with a focus on clear, audit-ready documentation.
• Veterinary or animal health experience is a plus but not required.
• Prior exposure to NDA resubmissions or first approvals is advantageous.

Benefits

• Competitive salary range: $155,000 – $205,000
• Full medical, dental, and vision coverage for employees and dependents
• Company equity options grant for new hires
• $1,000 home office equipment stipend
• $1,200 annual learning and development budget
• $250 monthly wellness budget (gym, wellness services, food, etc.)
• Unlimited vacation and paid holidays
• Regular 4-day long weekends
• Paw-ternity leave for new pet adoption
• Inclusive and flexible work environment
• Equal opportunity workplace with strong values-driven culture.

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role’s core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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