Senior/Executive Director, Head of Quality

Position:          Senior/Executive Director, Head of Quality 
Department: CMC
Location:         Remote (PST Zone) with up to 20% global and domestic travel
Reports To:    Chief Technology Officer

Position Summary

Angitia is seeking a Head of Quality to lead all GxP Quality functions, including Quality Assurance, Quality Control, R&D Quality, Document Control, Supplier Quality, and Quality Systems. This position will define and drive the company’s quality vision, ensuring compliance across global operations and supporting programs from early development through commercialization. The ideal candidate brings deep expertise in large molecule and aseptic manufacturing, regulatory requirements, and global vendor oversight, along with a proven ability to scale quality systems, lead inspections, and manage cross-functional teams in a dynamic, fast-paced environment. Fluency in English and Mandarin is required.

Responsibilities

• Drive a culture of quality and set strategic goals in collaboration with cross-functional teams, ensuring compliance with regulations, guidelines, and corporate standards.
• Shape and execute the path from pre-IND through commercialization by developing and implementing phase-appropriate Quality models aligned with ICH risk-based guidance.
• Build and optimize scalable Quality Systems to support effective, compliant operations.
• Oversee quality oversight of CDMOs, CROs, contract labs, and critical material suppliers; identify risks and lead remediation using a risk-based approach.
• Partner with external Quality teams to ensure uninterrupted supply and support current and future production plans.
• Lead and resolve major deviation investigations to safeguard product quality, safety, and efficacy.
• Manage Quality metrics, monitor compliance trends, and implement mitigation plans as needed.
• Support global regulatory submissions (IND, NDA, BLA) in partnership with Regulatory Affairs and lead company-wide readiness and execution for regulatory inspections.
• Lead and host all FDA and Health Authority inspections and facilitate Quality related continuous improvement initiatives
• Oversee Quality Agreement negotiations and manage budget, capital planning, and cost optimization.

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline, with at least 12 years of industry experience and 8–12 years in Quality Assurance, or an equivalent combination of education and experience.
• Proven experience in large molecule and aseptic manufacturing; experience in tech transfer and GMP facility operations strongly desired.
• Demonstrated success building Quality Systems in early-stage, science-driven organizations and supporting product commercialization.
• Experience working with U.S. and international CDMOs, clinical sites, and leading audits of external labs and suppliers.
• Deep understanding of CDE, FDA, and ICH GxP regulations, including GMP, GLP, GCP, and GDP.
• Strong knowledge of regulatory requirements for sterile products, advanced therapies, and combination products.
• Proven leadership in building and scaling high-performing teams in fast-paced environments.
• Strong mentoring, problem-solving, and critical thinking skills.
• Bilingual fluency in English and Mandarin required.

Salary Range: $210,000 to $280,000

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com.

Benefits:

• Medical, dental, and vision coverage for employees and their eligible dependents
• 401(K) Retirement Plan with Company match
• Company paid Long Term Disability Coverage
• Company-paid life Insurance & AD&D Coverage
• Voluntary Life Insurance & AD&D Coverage
• Employee Assistance Program (EAP)
• Company-paid Holidays
• Vacation
• Paid Sick Leave
• Telecommunication Monthly Stipend
• Work-From-Home Equipment Reimbursement