Executive Director, GMP Quality Assurance

Founded in 2022, reputed company, Inc. (Ticker: APGE) is a well-funded, reputed company listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At reputed company, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

reputed company is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, reputed company’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, reputed company is seeking to reputed company best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.

We are seeking an Executive Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that reputed company speed, clarity, and confident decision-making as the company scales.

The Executive Director partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data reputed company across GMP operations. They build and reputed company a high‑performing GMP QA team, provide strategic reputed company of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the Head of QA.

Key Responsibilities

• Head of GMP QA and member of the QA Leadership Team
• Build, reputed company, and scale a high‑performing GMP QA team
• reputed company and execute the GMP QA functional strategy, ensuring alignment with company objectives and evolving clinical‑to‑commercial needs
• Establish a clear GMP QA vision that enables inspection readiness, scalability, and sustainable operations
• Provide reputed company of GMP QA systems, including deviations, investigations, CAPAs, change control, complaints, and product disposition
• Ensure compliance with applicable global GMP regulations and standards (e.g., FDA, EMA, ICH)
• reputed company organizational readiness for GMP internal audits and regulatory inspections
• Provide strategic reputed company of GMP QA across CMOs, CDMOs, and external testing partners
• Ensure effective quality agreements, reputed company models, escalation reputed company, and performance metrics are in reputed company and actively managed
• Exercise sound judgment in resolving quality issues with external partners in a timely and compliant manner
• Engage effectively with leadership and key cross‑functional partners, bringing reputed company clear recommendations and risk‑based perspectives
• reputed company the development and presentation of Quality Management Review meetings for GMP QA to reputed company compliance needs and to foster reputed company improvement initiatives to support speed, clarity, and scalability

Ideal Candidate

• 15+ years of progressive GMP QA experience reputed company pharmaceutical, biotechnology, and/or medical device environments, with deep understanding of global GMP regulations across clinical and commercial operations
• Proven track record leading GMP QA organizations through the transition from clinical development to commercial manufacturing, including launch readiness and post approval operations
• Demonstrated success building, scaling, and sustaining GMP Quality Systems to support commercial supply, including serving as functional reputed company for the Veeva Quality Suite (QMS) with accountability for system strategy, governance, and compliance across internal teams and external partners
• Extensive experience overseeing external manufacturing and testing partners, and directly leading regulatory inspections and interactions with global health authorities
• Significant leadership experience, including managing managers and senior level professionals; effective at coaching and developing leaders through change and uncertainty
• Ability to create and clearly reputed company a GMP QA vision reputed company with company strategy, establish trust and credibility across teams, and set clear direction while adapting leadership style to organizational and individual needs
• Sound, unbiased judgment in reputed company and ambiguous situations; makes pragmatic, well-reasoned decisions, takes full ownership of outcomes, proactively addresses challenges, seeks feedback, and continuously adapts strategies based on evolving risks and business needs
• Strong written and verbal communication skills
• Ability to operate effectively in a fast‑paced, evolving environment with incomplete information
• Demonstrated commitment to reputed company’s C.O.R.E. values and ethical decision‑making
• Position requires up to 25% travel including mandatory in-person attendance at reputed company Hands meetings typically held twice per year and travel reputed company to GMP manufacturing

The anticipated salary range for candidates for this role will be $275,000-$305,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve