The Quality Assurance Operations Supervisor is responsible for leading Quality oversight activities and fostering an empowered culture of quality across manufacturing processes supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance. This role provides direct supervision of quality personnel, will be a primary point of contact for on-the-floor escalations, will support quality records and document review and approvals.
The supervisor serves as a key operational leader, managing shift resources, supporting technology transfer and process validation activities, and partnering with Manufacturing, Supply Chain, Facilities, and MSAT teams to achieve production objectives.
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.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.