Supervisor, Quality Program Management

Supervisor, Quality Program Management in Albuquerque, NM

The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team, fostering strong client quality relationships and ensuring the timely review and disposition of executed batch records across clinical, commercial, and media fills.

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

• Supervise and provide guidance to the QA batch record review and product disposition team
• Support client Quality relationships through effective communication and timely deliverables
• Review and assist in the disposition of executed Batch Records (Clinical, Commercial, & Media Fills) and collaborate with cross‑functional teams to address review comments
• Maintain the record review planner to track and monitor the stages of the batch disposition process, including manufacturing and quality reviews and quality disposition processes
• Support efforts to monitor and improve batch record review and disposition cycle times
• Assist in tracking metrics for the review and disposition process and provide input for monthly performance analysis
• Oversee Disposition timelines and support client calls related to Disposition schedules and delays
• Ensure timely responses to client comments on Batch Records
• Coordinate with QC labs, external testing, and the deviations team to ensure all deliverables are completed on time to meet supply commitments
• Coordinate shipments with the Warehouse (including Q Ships & Release Shipments)
• Participate in critical DEV review meetings and provide quality input as needed
• Contribute to the preparation and presentation of weekly and monthly metrics for leadership
• Assist in developing batch record review training materials for Quality and Production teams
• Review and provide input on SOPs related to the functional area
• Support internal, client, and regulatory audits for batch record reviews
• Identify process improvements and assist in their implementation
• Provide support in other QA areas as assigned by QA Management
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

• Bachelor’s degree in Science, Chemistry, Biology or related field of study
• Minimum of three (3) years in Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) years in a leadership role
• Minimum of three (3) years in an aseptic/sterile product facility, preferred
• Knowledge in current regulations (21
  
  CFR, Annex 1 etc), preferred

This role is responsible for leading and supporting a team, overseeing day‑to‑day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve departmental and organizational objectives.

The ideal candidate should have the ability to read and interpret various documents including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills and effective presentation skills are required.

Proficient in arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Strong grasp of algebraic and geometric principles.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Interpret extensive technical instructions in mathematical or diagram form and handle abstract and concrete variables.

Strong technical foundation and experience utilizing manufacturing and Internet software. Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and…