Oruka Therapeutics - Director, GMP Quality Assurance
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Requirements
• Bachelor’s degree in a scientific field with a minimum of 10 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.
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. • 15–20% travel
Benefits
• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. • The anticipated salary range is $213,000-$240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. • Job Location: • Hybrid – Waltham, MA or Menlo Park, CA. Candidates will be required to be in-office 3 days/week. Open to remote for non-local candidates. • We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. • 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.
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