Tbwa Chiat/Day Inc
Senior Director of GMP Quality Assurance Waltham, Massachusetts, United States
Tbwa Chiat/Day Inc, Waltham, Massachusetts, United States, 02254
Senior Director of GMP Quality Assurance
Waltham, Massachusetts, United States About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Position Overview:
The Senior Director of GMP Quality Assurance will report to the VP of Quality. As the Sr. Director of GMP Quality Assurance, you will be responsible for providing quality oversight for Oruka’s clinical development programs and manufacturing. You will develop and implement a GMP quality assurance strategy that ensures compliance with regulatory requirements, applicable guidelines, and industry best practices. You have a strong background in GMP quality and manufacturing of biologics, with an emphasis on external manufacturing CDMO interaction and partnership. You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment. You are a hands on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers. Key Responsibilities: Provide quality support and guidance for Oruka’s CMC programs, ensuring GxP compliance with applicable guidelines and regulatory requirements. Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers. Provide ongoing quality oversight and management for GMP suppliers (contract manufacturers, laboratories, packagers, distributors, and storage facilities). Negotiate quality agreements with GMP suppliers. Review and approve controlled documents including, but not limited to: master batch records, executed batch documentation, analytical test methods, specifications, validation protocols and reports, analytical/tech transfer protocols and reports, stability protocols and reports, release testing COAs and reports. Review and support GMP investigations associated with lot-related deviations, ensuring that appropriate follow-up actions (i.e., CAPA) are defined and implemented. Review change controls, CAPAs, OOS/OOT investigations. Ensure that GMP quality documentation is securely archived and retrievable. Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions. Contribute to the development of Oruka QMS as needed, including the authoring or review of procedures and systems governing batch release, product complaints, OOS/OOT investigations, stability program management, etc. Support in the development, compiling, reporting, and reviewing of GMP-related quality metrics and key performance indicators. Identify trends requiring corrective action and participate in the development and implementation of the corresponding CAPA plan. Ensure inspection readiness both internally and at Oruka’s GMP suppliers, in accordance with established timelines. Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests. Advise senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues. Champion continuous improvement of quality and compliance practices to ensure highest standards are maintained. Approximately 10-20% travel (domestic and international) to GMP suppliers and Oruka offices. Basic Qualifications: Bachelor’s degree in a scientific field with a minimum of 12 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 Qualifications: Advanced degree in a scientific field with a minimum of 12 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required. Experience in building and managing a team or group desired. Direct experience in supporting regulatory inspections is preferred. Proven experience in successfully standing up and managing new GMP vendors, including interfacing with new CDMOs and negotiating quality agreements. Salary Range for the Role: $248,000 - $260,000 USD What We Offer: A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients. Competitive salary and benefits package. Opportunities for professional growth and development. Apply for this job #J-18808-Ljbffr
Waltham, Massachusetts, United States About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Position Overview:
The Senior Director of GMP Quality Assurance will report to the VP of Quality. As the Sr. Director of GMP Quality Assurance, you will be responsible for providing quality oversight for Oruka’s clinical development programs and manufacturing. You will develop and implement a GMP quality assurance strategy that ensures compliance with regulatory requirements, applicable guidelines, and industry best practices. You have a strong background in GMP quality and manufacturing of biologics, with an emphasis on external manufacturing CDMO interaction and partnership. You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment. You are a hands on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers. Key Responsibilities: Provide quality support and guidance for Oruka’s CMC programs, ensuring GxP compliance with applicable guidelines and regulatory requirements. Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers. Provide ongoing quality oversight and management for GMP suppliers (contract manufacturers, laboratories, packagers, distributors, and storage facilities). Negotiate quality agreements with GMP suppliers. Review and approve controlled documents including, but not limited to: master batch records, executed batch documentation, analytical test methods, specifications, validation protocols and reports, analytical/tech transfer protocols and reports, stability protocols and reports, release testing COAs and reports. Review and support GMP investigations associated with lot-related deviations, ensuring that appropriate follow-up actions (i.e., CAPA) are defined and implemented. Review change controls, CAPAs, OOS/OOT investigations. Ensure that GMP quality documentation is securely archived and retrievable. Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions. Contribute to the development of Oruka QMS as needed, including the authoring or review of procedures and systems governing batch release, product complaints, OOS/OOT investigations, stability program management, etc. Support in the development, compiling, reporting, and reviewing of GMP-related quality metrics and key performance indicators. Identify trends requiring corrective action and participate in the development and implementation of the corresponding CAPA plan. Ensure inspection readiness both internally and at Oruka’s GMP suppliers, in accordance with established timelines. Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests. Advise senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues. Champion continuous improvement of quality and compliance practices to ensure highest standards are maintained. Approximately 10-20% travel (domestic and international) to GMP suppliers and Oruka offices. Basic Qualifications: Bachelor’s degree in a scientific field with a minimum of 12 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 Qualifications: Advanced degree in a scientific field with a minimum of 12 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required. Experience in building and managing a team or group desired. Direct experience in supporting regulatory inspections is preferred. Proven experience in successfully standing up and managing new GMP vendors, including interfacing with new CDMOs and negotiating quality agreements. Salary Range for the Role: $248,000 - $260,000 USD What We Offer: A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients. Competitive salary and benefits package. Opportunities for professional growth and development. Apply for this job #J-18808-Ljbffr