Associate Director, GMP Quality Assurance
Oruka Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • United States
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Salary
💰 $175,000 - $200,000 per year
Job Level
About the role
- 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.
Requirements
- 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.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
GMP quality supportGxP regulationsmaster batch recordsanalytical methodsvalidation protocolsCAPA developmentrisk assessmentQuality Management System (QMS)GMP quality metricsregulatory submissions
Soft Skills
analytical skillsinvestigative skillsproblem-solving skillsinterpersonal skillscommunication skillsteam orientationmentoringability to prioritizeability to manage multiple tasksadaptability