Quality Assurance Operations Supervisor

Salary Range: 100000 to 120000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Lead hands-on QA collaboration and oversight to staff, ensuring compliance with good documentation practices (GDP), data integrity compliance, site inspection readiness SOPs, and relevant Good Regulated Practice (GxP) requirements.
• Supervise work on the floor during production and assess decisions to ensure compliance with manufacturing procedures and regulations when departures occur.
• Lead batch record review on the floor at time of execution for buffer / media/ upstream and downstream manufacturing batch records.
• Lead disposition of buffer/media solutions manufactured at Abzena.
• Supervise performance of regular area walkthroughs of the manufacturing, warehouse and Quality Control areas.
• Author/Approve minor and major manufacturing deviations and perform a thorough root cause to drive remediation efforts in the organization and process improvements.
• Review and approve manufacturing deviations (minor/major), risk assessments, CAPAs, change controls, and Standard Operating Procedures (SOPs).
• Review and approve master buffer / media / Process batch record and client batch records.
• Support in client and internal audits as required.
• Support other departments as required to fulfill business needs.
• Comply with Abzena's policies and procedures.
• Communicate effectively with clients, colleagues and staff.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.

Team Leadership & Development

• Supervise, coach, mentor, and develop quality assurance associates
• Conduct performance evaluations and establish development plans for team members.
• Facilitate onboarding and qualification of new employees.
• Promote a culture of safety, teamwork, accountability, and continuous improvement.
• Lead daily shift meetings and attend daily tier meetings as required.

Safety & Operational Excellence

• Champion Environmental Health and Safety (EHS) compliance.
• Ensure safe handling of biological materials, chemicals, and manufacturing equipment.
• Lead risk assessments and support implementation of corrective actions.
• Drive Lean Manufacturing and continuous improvement initiatives.
• Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.

Cross-Functional Collaboration

• Partner with Manufacturing, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams.
• Support customer visits and client-facing manufacturing discussions as required.

Qualifications

Requirements:

• Bachelor’s degree in Life Sciences, or related scientific discipline.
•  Minimum of 4 years of experience in biopharmaceutical manufacturing within a GMP-regulated environment. 
• Minimum of 3 years of experience in a Quality Assurance related function
• Minimum of 2 years of leadership or supervisory experience.
• Hands-on experience with biologics operations in either a Quality or Production role. 


  
Qualifications (Preferred)

• Experience in CDMO manufacturing environments. 
• Lean Six Sigma certification or continuous improvement experience.
• Knowledge of monoclonal antibody and recombinant protein manufacturing processes.