Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Boulder, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Boulder, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front. 

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.  

Umoja Biopharma – Your Body. Your Hope. Your Cure.  

POSITION SUMMARY  

Umoja Biopharma is looking for a Quality Assurance Manager to own, manage, and oversee programs and processes for supplier qualification and monitoring of GxP materials & services. This includes suppliers providing materials and services in support of internal and external (e.g., CDMO/CMO) production, labeling, analytical testing, storage, and distribution activities to support our early-stage small molecule and cell/gene therapy pipelines. 

 
REQUIREMENTS   

Specific responsibilities include:    

  • Owns, authors, and manages controlled document lifecycle related to supplier qualification and external Quality programs and processes 
  • Serves as Quality representative at Program and CMC teams for select Umoja platforms 
  • Provides Quality oversight in support of external manufacturing, packaging, labeling, analytical testing, storage, and distribution, such as:
    • Reviews and approves Master Batch Records and Executed Batch Records, analytical methods, method qualification & validation reports, and lot release/stability data in support of CDMO/CMO activities
    • Supports creation and control of material specifications, label content, etc.
    • Dispositions raw materials, DS, DP, and packaged/labeled product prior to delivery to clinical sites
    • Reviews and approves stability protocols and reports for externally manufactured materials 
  • Serves as Umoja Quality point-of-contact, building and maturing effective and productive working relationships with suppliers of GxP materials and services
  • Supports supplier selection process with cross-functional input
  • Coordinates, manages, and leads qualification questionnaires, audits, and recertification events for identified suppliers and service providers in collaboration with cross-functional SMEs
  • Authors supplier qualification audit reports
  • Reviews and approves supplier quality events/records (e.g., Deviation, CAPA, Change Control, temperature excursions, etc.) 
  • Manages the supplier notification and change process, working closely with cross-functional SMEs to assess and document impact 
  • Establishes, manages, and maintains Quality Agreements In collaboration with suppliers and service providers
  • Owns and manages corrective and/or preventive actions as outcomes from supplier qualification audits, recertification events, investigations, and/or supplier performance issues (e.g., SCAR process)
  • Discontinues the use of and/or disqualifies suppliers based on performance issues and/or changing business needs
  • Develops, trends, and manages key performance indicators and metrics related to supplier qualification program, including representing supplier qualification at Quality Management Review
  • Proposes and implements continuous improvement initiatives around supplier qualification and external Quality programs
  • Supports and authors sections of regulatory filings, as needed
  • Provides additional support within the Quality organization, as needed 

The successful candidate will have: 

  • Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science
  • Minimum of 8 years of work experience in an FDA-regulated, cGMP industry 
  • Advanced knowledge and understanding of regulatory compliance requirements, guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment
  • Strong understanding in practical application of foundational Quality systems (e.g, supplier management, Deviation/CAPA, risk management, etc.)
  • Experience with analytical method development, transfer, qualification and lifecycle management, and results evaluation across analytical technologies
  • Extensive experience working closely with, and managing, critical suppliers, CDMO/CMO, and/or contract testing laboratories
  • Experience supporting regulatory filings
  • An unwavering commitment to purpose, team success, and fostering an outstanding workplace culture
  • Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic startup environment
  • Ability to think and lead conceptually, strategically, and tactically, arriving at practical and pragmatic conclusions
  • Ability to translate complex processes and competing priorities into a clear, actionable plan for execution 

Preferred Qualifications:    

  • Experience working with small molecules and cell/gene therapies 
  • Previous experience in cGMP biopharmaceutical manufacturing facility startup environment  
  • Supervisory experience is preferred  

Physical Requirements:    

  • Ability to travel approximately 10% 
  • Ability to primarily work onsite, working from home when needed 

Salary Range: $120,000 - $145,000

COVID-19 Policy

Pursuant to Umoja Biopharma’s Vaccine Policy, we are currently requiring all employees to be fully vaccinated to work onsite or visit any of our physical locations. In addition, you must provide proof of vaccination to work onsite or visit any of our physical locations. Umoja will consider reasonable accommodation for medical condition/disability and sincerely held religious belief, practice or observance unless such accommodation would result in an undue hardship.

Benefits Offerings

Umoja Biopharma offers its employees comprehensive Medical, Dental, and Vision plans through Premera Blue Cross, Delta Dental, and VSP, respectively, with no premium costs to our employees. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive, unlimited Paid Time Off policy, employee commuter benefits, and childcare reimbursement. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

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