Angitia Biopharmaceuticals ยท 8 hours ago
Director to Senior Director, Quality Control
United States
Full-time
Remote
Director/Executive
$210K/yr - $265K/yr
12+ years expAngitia Biopharmaceuticals is a clinical-stage biotechnology company focused on innovative therapeutics for serious musculoskeletal diseases. The Director/Senior Director of Quality Control will lead the QC strategy and oversee outsourced QC testing activities, ensuring compliance with regulatory standards and alignment with company objectives.
Biotechnology
Responsibilities
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
Qualification
Required
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
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
Preferred
Advanced degree (PhD, MS, or equivalent) in Chemistry, Biochemistry, Molecular Biology, or related field highly preferred
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
Company
Angitia Biopharmaceuticals
Angitia is a clinical-stage biotechnology company focused on discovering and developing breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.
51-200 employees
Funding
Current Stage
Growth StageRecent News
2024-01-19
2023-12-19
BioWorld Financial Watch
2023-10-30
Company data provided by crunchbase