QA Operations Manager
- Experience Level
Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.
Our recent successes are driving significant growth. As such, we are looking for a QA Operations Manager to join our QA team. The purpose of this role is to manage the Quality Assurance team responsible for supporting the Manufacturing Operations, Quality Control testing laboratories and supporting function’s activities of Oxford Biomedica’s Cell and Gene Therapy business.
Key responsibilities and accountabilities:
- Providing leadership, setting Goals & Objectives, facilitating problem resolution, resource utilization, work planning, delegating & evaluating, coaching and mentoring of team members.
- Responsible for engaging strong intradepartmental and cross-functional / organizational relationships to drive quality requirements.
- The Quality Assurance Operations Manager is responsible for Quality Assurance functions for plant-wide systems / process including, but not limited to;
- Batch record review supporting QP Certification & Release activities.
- Direct line support to GXP areas including driving “Quality on the floor” presence during manufacturing operations to assist and support the manufacturing staff in detecting and solving compliance errors in real time.
- Interfacing with other site functions (Manufacturing, Quality Control, Validation / Process support, Engineering & Facilities, Validation & Technical support, Warehouse & Supply Chain) and providing support with Deviation handling / Problem solving, Laboratory Investigations / Out of Specifications, Risk assessments, Continuous improvement, Change control, CAPA and Complaints.
- Quality Risk Management - performing activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks identified in Manufacturing, Quality Control and supporting functions.
- Supporting site wide internal & external audit programs
- Validation & Engineering Documentation – Review & Approvals
- Writing, revising, and/or reviewing SOPs and policies to reflect industry expectations & regulatory requirements.
- Representing QA on projects and advising on the adequacy of validation of facilities, equipment, products/processes, including strategies to ensure adequate data is gathered so informed decisions can be made.
- Identifying and Tracking Quality Key Performance Indicators (KPIs).
Key skills and requirements:
- Bachelor’s of Science Degree.
- Experience working within Pharmaceutical Industry (Sterile Aseptic Manufacturing Processes).
- Experience of Biotechnology, ATMPs (Advanced Therapy Medicinal Products) is an advantage.
- Understanding & experience of cGMP and pharmaceutical industry QA requirements.
- Working knowledge of cGxP (GMP, GCP & GLP) related pharmaceutical regulations & standards.
- Extensive working knowledge of Quality Management systems in both a laboratory and manufacturing setting; specifically, validation activities (Including CSV), production & process controls, Deviation / problem solving, Change Control, Corrective & Preventive Action (CAPA), Risk management, Sterility Assurance, Calibration & Preventative Maintenance, Data Integrity & product quality improvement using tools such as six sigma, Lean principles etc.
- Experience of conducting quality based audits, investigations and root cause analysis
- Experience of regulatory and or customer /client audits and inspections.
- Ability to simplify strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely.
- Line management experience with proven managerial/leadership skills such as work planning, delegating & evaluating.
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance with product registered detail, regulations & industry expectations. Ability to make decisions, even when under pressure & take ownership for assigned work.
- Change agent with energy, passion & enthusiasm to drive change.