Director to Senior Director, Quality Control

Position: Director / Senior Director, Quality Control
Department: CMC
Location: Remote with up to 20% global and domestic travel
Reports To: VP, Head of Quality

Position Summary

Angitia is seeking an experienced and strategic Director of Quality Control to help lead the next phase of development. This role will operate at both the strategic and execution levels, providing oversight of Angitia's fully outsourced QC testing network. Partnering closely with Analytical Development, Quality Assurance, Manufacturing, and Regulatory Affairs, the Director will establish QC strategy, manage vendor relationships, and provide technical leadership in validation, transfers, specifications, and QC testing to support Angitia's global clinical development programs.

Responsibilities

Strategic Oversight

• Define and implement QC strategy aligned with company objectives.
• Partner with Analytical Development, Quality Assurance, CMC, and Regulatory Affairs teams to ensure cross-functional alignment in program planning and execution.
• Serve as the primary QC liaison with CTOs/CMOs, driving accountability and timely delivery.
• Communicate program status, risks, and mitigation strategies to senior leadership.
• Collaborate with CMC Ops to align QC deliverables (specifications, stability data, method validations) with manufacturing and supply chain timelines.
• Identify potential risks and implications raised from QC data, and drive technical risk mitigation in collaboration with internal and external teams

Vendor Management

• Oversee outsourced QC testing activities, including raw materials, in-process, release, and stability testing.
• Establish KPIs and governance processes to monitor vendor performance.
• Ensure QC activities comply with cGMP, ICH, FDA, EMA, and other relevant guidelines.
• Review and approve QC documentation, including test methods, protocols, and reports.

QC Operations Oversight

• Establish, maintain, and update product specifications in alignment with regulatory expectations.
• Design and oversee stability programs for clinical and commercial materials.
• Provide oversight of outsourced complex investigations, including out-of-specification (OOS), out-of-trend (OOT), and atypical results, ensuring robust root cause analysis and CAPA implementation.

Analytical Leadership

• Ensure method validation, transfer, and lifecycle management are executed to regulatory standards and program timelines.
• Collaborate with Analytical Development to provide technical guidance on analytical methods (e.g., potency assays, binding assays, HPLC, ELISA).
• Support regulatory submissions through review and/or authorship of relevant dossier sections.

Qualifications

• 12+ years of experience in Quality Control and/or Analytical Development within biotech/pharma, with strong preference for experience in both clinical and commercial settings.
• Advanced degree (PhD, MS, or equivalent) in Chemistry, Biochemistry, Molecular Biology, or related field highly preferred.
• Demonstrated success managing outsourced QC activities with CMOs/CTOs.
• Strong background in biologics, preferably monoclonal antibodies, bispecifics, or ADCs.
• Proven ability to lead cross-functional teams and influence without direct authority.
• Deep understanding of cGMP, ICH Q-series guidelines, and global regulatory expectations for biologics.
• Exceptional organizational, communication, and strategic thinking skills.
• Bilingual in Chinese and English preferred.

Salary Range: $210,000 - $265,000

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, osteogenesis imperfecta (OI), and spinal fusion. 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