Senior Manager, Quality Operations

Company: System One
Location: Poway
Posted on: June 12, 2022

Job Description:

Job DescriptionTitle: Sr. Manager, Quality OperationsLocation: Poway, CaSchedule: M-F 8am-5pmCompensation: Midpoint 130K + Bonus and Benefits *please note this is the midpoint, flexibility depending on experience Type: Direct/Permanent Start date: ImmediateThe Sr. Manager, Quality Operations is responsible for overseeing and leading the Quality Operations function. The Quality Operation functions include: on-the-floor manufacturing support, batch record disposition and management, quality client liaison, investigation and resolution of product deviations, and ensuring compliance with applicable regulatory and industry standards for phase-appropriate GMP manufacture of cell therapies. This position plays a key role in demonstrating the values, culture, and deliverables for the site.Responsibilities:

• Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees, and conducting performance reviews
• Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors the progress of deliverables and provides support to staff to ensure success
• Facilitates QA support and works closely with other PCM functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regard to the facility and products manufactured
• Provides strategic oversight and leadership to QA Client liaisons and operations to ensure project objectives are met to a high-quality standard and according to commitments
• Directs the batch record review and lot disposition activities to ensure the release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
• Member of the Quality management team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation related to the area
• Strategy reviewer, from a Quality validation perspective, of quality system documents including but not limited to CAPA, change controls, investigations, and deviations
• Serve as the team leader in quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
• Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy
• Ensure current Good Manufacturing Practices (cGMPs) compliance for manufacturing of the biological product, and compliance to US and EU regulations, as applicable
• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
• Work with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.Requirements:
  • BS in a Life Science discipline
  • 8+ years of industry experience
  • 4+ years' experience in direct management
  • Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP, and other applicable regulations and guidance
  • Knowledgeable and/or exposure to biological manufacturing processes, such as cell and gene therapy, vaccine, cell banking, and aseptic fill finish
  • Exposure to contract manufacturing and facility build-out is a plus.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients
  • Ability to self-direct, and adapt to changing priorities
  • Proven technical writing and editing skills
  • Ability to work effectively under pressure to meet deadlines

Keywords: System One, Poway , Senior Manager, Quality Operations, Executive , Poway, California