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Angitia Biopharmaceuticals logo
Angitia Biopharmaceuticals

Developing innovative medicines to address serious musculoskeletal diseases

Senior Director, Quality Control

DirectorDirectorOtherRemoteSeniorTeam 51-200Since 2018H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

144 days ago

Salary

$210K - $265K / year

Seniority

Senior

Postgraduate Degree12 yrs expChineseEnglish

Job Description

Senior Director, Quality Control

Angitia Biopharmaceuticals

• 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.

Job 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

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