POSITION SUMMARY

Umoja Biopharma is seeking a Senior Specialist, Quality Assurance to provide Quality Assurance oversight and subject matter expertise in support of new product introduction, and routine current Good Manufacturing Practice (cGMP) operations. This role partners closely with Manufacturing, Process Sciences, Engineering, Facilities, Quality Control, Supply Chain, Regulatory Affairs, and other functions to ensure operations are conducted in accordance with approved procedures, internal quality standards, and applicable regulatory requirements. The Senior Specialist, Quality Assurance independently provides quality guidance, reviews and approves GMP documentation, supports investigations and change implementation, provides on-the-floor QA oversight, and contributes to the development and continuous improvement of site quality systems.

CORE ACCOUNTABILITIES
Specific responsibilities include:

• Independently provides Quality oversight and direction in support of task execution during site start-up and routine cGMP (current Good Manufacturing Practice) operations.
• Interfaces with other departments (e.g., Supply Chain, MSAT, Facilities, Validation, Manufacturing, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards.
• Provides strategic quality input and subject matter expertise on implementation of site material controls.
• Reviews and approves material specifications and performs material disposition.
• Reviews and approves Master Batch Records, work instructions, SOPs, specifications, and other controlled documents related to operations and other cGMP activities as needed
• Reviews and approves SOPs, work instructions, product specifications, and other controlled documents related to operations and other cGMP activities as needed.
• Reviews and approves Deviations, CAPAs (Corrective and Preventative Actions), and Change Controls.
• Develops, trends, and manages key performance indicators and metrics related to Umoja Quality Systems.
• Assists in the design and/or implementation of processes for batch record review and product disposition.
• Partners directly with other functional areas by providing Quality-on-the-floor oversight and real-time support.
• Other duties as assigned.

The successful candidate will have:

• Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or a related life sciences or technical discipline.
• Minimum of 8+ years of experience in an FDA-regulated industry.
•  Equivalent combinations of education, training, and relevant experience may be considered.
• Strong working knowledge of cGMP requirements and Quality Systems.
• Ability to independently assess quality and compliance risks and make sound, timely decisions.
• Ability to provide effective on-the-floor Quality support in a dynamic manufacturing environment.
• Strong understanding of good documentation practices and data-integrity principles.
• Ability to interpret and apply regulatory requirements in a practical and risk-based manner.
• Strong technical writing, investigation, analytical, and problem-solving skills.
• Strong interpersonal and cross-functional collaboration skills.
• Ability to appropriately challenge decisions while maintaining productive working relationships.
• Strong verbal and written communication skills.

Preferred Qualifications:

• Experience supporting viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing operations.
• Experience with batch record review and product disposition.
• Knowledge of FDA regulations, EU GMP requirements, ICH guidelines, and applicable industry standards.
• Previous experience participating in cGMP audits and inspections.

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment, if required.
• Ability to work while gowned for extended periods of time, if required.
• Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required.
• Use of laboratory equipment includes handling chemicals and biological materials.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
• Ability to work occasional nights and weekends as needed.
• Ability to primarily work onsite, working remotely when appropriate.

Salary Range: $105,060 - $129,780