Oruka Therapeutics

Oruka Therapeutics

Manager/Sr. Manager QA Supply Chain

Waltham, Massachusetts, United States · Senior

Sponsorship not specified$146k-$161kDetected 55 days ago
GCPSupply ChainLogisticsClinical TrialsGMPProblem Solving

About the role

  • The Manager / Senior Manager, QA Supply Chain is responsible for providing quality oversight of clinical supply chain activities supporting Phase 2 and Phase 3 programs, including packaging, labeling, distribution, and cold chain management.
  • This role ensures inspection readiness and compliance across all clinical supply operations.

Responsibilities

  • Support phase-appropriate quality systems and procedures as programs advance from Phase 2 to Phase 3.
  • Provide QA support and oversight for IRT systems, including review and approval of system specifications, user acceptance testing (UAT), and change controls.
  • Partner with Clinical Operations and Supply Chain to ensure accurate and compliant IRT configuration and use.
  • Collaborate with cross-functional clinical teams to review and update study specific pharmacy manuals.
  • Support qualification and oversight of depots, logistics providers, and distribution partners.
  • Lead or support investigations related to deviations, temperature excursions, shipment issues, product complaints, and labeling errors.
  • Support QA Supply Chain activities for regulatory submissions and inspections.

Requirements

  • Bachelor's degree in Life Sciences, Supply Chain, or related discipline.
  • 5+ years (Manager) or 8+ years (Senior Manager) of experience in Quality Assurance within GMP/GDP environments.
  • Experience supporting clinical supply chain operations in Phase 2 and/or Phase 3 trials.
  • Working knowledge of GMP, GDP, and GCP regulations applicable to investigational products.
  • Experience with IRT systems and clinical supply management processes.
  • Hands-on experience with clinical labeling, packaging, and distribution oversight.
  • Experience managing temperature excursions and cold chain logistics.
  • Familiarity with deviation management, investigations, and CAPA systems.
  • Experience supporting global clinical trials and multi-region supply chains.
  • Experience with comparator sourcing and depot management.
  • Required
  • Strong organizational and problem-solving skills with attention to detail.
  • Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.
  • Preferred

Compensation

  • 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 for candidates who will work in Waltham, MA for Manager level is $146,000 - $161,000 and for Sr.
  • Manager is $161,000 - $187,000.
  • 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. Candidates will be required to be in-office 3 days/week

Benefits

  • Competitive salary and benefits package.
  • Support responses to health authority inquiries related to clinical supply chain operations.

Company info

  • 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. 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.
  • Job Title: Manager / Senior Manager, QA Supply Chain
  • 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.
  • 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.
  • Candidates will be required to be in-office 3 days/week.
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
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This listing is sourced directly from Oruka Therapeutics's careers page and normalized into a canonical job model.