Senior Specialist, Quality Assurance, External Supplier

POSITION SUMMARY

We are seeking a highly motivated individual to join our growing Quality Assurance team. This individual will play a key role in Umoja’s state-of-the-art lentiviral vector development and manufacturing facility, The CLIMB, in Louisville, CO.

In collaboration with Quality management and multiple functions, this individual will execute, mature, and drive continuous improvement of key aspects of the vendor management program.  Additionally, this role will collaborate with cross-functional teams to ensure quality requirements are defined, clearly communicated and understood, and met as part of routine and advancing GxP operations. 

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Works effectively and leads cross-functionally across Umoja to fulfill Vendor QA oversight and performance monitoring responsibilities.
• Manages the GMP supplier notification and change process with limited Management oversight and direction, working with cross-functional subject matter experts (SMEs) to assess and document impact. 
• Manages the Supplier Corrective Action Record (SCAR) process and material defect management process with limited Management oversight and direction.
• Performs vendor recertification events for identified vendors with limited Management oversight and direction in collaboration with cross-functional SME.
• Provide support for the Vendor Management program, as needed.
• Executes controlled document archival process, when required.
• Authors, reviews, and/or approves Standard Operating Procedures (SOPs) and other controlled documents as Quality Assurance representative.
• Provide additional support within the Quality Assurance organization to provide Quality oversight and support to GxP tasks and programs, when needed.
• Support organizations outside of Quality, if needed, to accomplish facility objectives and routine operations.
• Other duties, as assigned

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 8+ years of experience in an FDA regulated industry, or similar combination of education and experience.
• Extensive experience with quality management systems and vendor management.
• Experience participating in external (vendor) audits.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance.
• Understanding of, and ability to apply, risk management principles and philosophy within the quality system in support of Phase 1/first-in-human products/programs.
• Strong communication and organizational skills and a passion for teamwork.
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas and vendors with minimal supervision.
• Previous experience in a Quality organization supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.
• Experience leading and implementing operational excellence initiatives and process simplification.

Preferred Qualifications:  

• Previous experience with a vendor management program in a current Good Manufacturing Practice (cGMP) environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

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, including standing for extended periods of time.
• Ability to sit in office setting for extended periods of time.
• Ability to work occasional nights and weekends as needed.
• Ability to work onsite 5 days/week

Salary Range: $105,100 - $130,000