Oruka Therapeutics · 20 hours ago
Associate Director, GMP Quality Assurance
Waltham, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$175K/yr - $200K/yr
8+ years expOruka Therapeutics is developing novel biologics aimed at treating chronic skin diseases. The Associate Director of GMP Quality Assurance will oversee quality for clinical development programs and manufacturing, ensuring compliance with regulatory requirements and industry best practices.
BiotechnologyHealth CareMedical
Responsibilities
Provide GMP quality support and guidance for Oruka’s CMC programs, ensuring compliance with applicable GxP regulations and guidelines
Support the negotiation, implementation, and maintenance of quality agreements with GMP suppliers
Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation
Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation
Review change controls, CAPAs, and OOS/OOT investigations in collaboration with internal and external stakeholders
Perform or support lot disposition activities
Ensure GMP quality documentation is appropriately archived and readily retrievable
Investigate and assess quality events such as product complaints and temperature excursions, and manage associated follow-up actions
Contribute to the development and maintenance of Oruka’s Quality Management System (QMS), including authoring and reviewing SOPs and quality procedures as needed
Review and approve clinical product labeling, ensure proper controls in place across label management lifecycle
Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives
Support inspection readiness activities for both Oruka and its GMP suppliers
Provide GMP quality review and input for regulatory submissions and agency responses
Escalate quality risks and compliance issues appropriately and support risk-based decision making
Promote a culture of quality and continuous improvement across the organization
Approximately 15–20% travel (domestic and international) to GMP suppliers and Oruka offices
Qualification
Required
Bachelor's degree in a scientific field with a minimum of 8 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required
In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges
Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff
Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously
Able to travel domestically and internationally
Preferred
Experience supporting the onboarding and oversight of new GMP vendors or CDMOs
Prior experience contributing to the build-out or enhancement of a QMS in a development-stage company
Experience with visual management dashboards (Excel/Smartsheet)
Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions
Benefits
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Competitive salary and benefits package.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.
Company
Oruka Therapeutics
Oruka Therapeutics is advancing innovative biologics to redefine patient care standards in chronic skin diseases.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Viking Global Investors
2025-09-17Post Ipo Equity· $180M
2024-09-03Post Ipo Equity· $275M
2024-09-03IPO
Recent News
2025-12-12
Oruka Therapeutics, Inc.
2025-11-13
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