Angitia Biopharmaceuticals

Senior Director, Quality Control

Angitia Biopharmaceuticals

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $210,000 - $265,000 per year

Job Level

Senior

About the role

  • 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.
  • 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.
  • 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.
  • 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.

Requirements

  • 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.
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality ControlAnalytical Developmentmethod validationpotency assaysbinding assaysHPLCELISAroot cause analysisCAPAKPI establishment
Soft skills
strategic thinkingorganizational skillscommunication skillsleadershipinfluence without authority
Certifications
PhDMS