Senior Manager, Quality Operations
Company: System One
Location: Poway
Posted on: June 18, 2022
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Job Description:
Title: Sr. Manager, Quality Operations
Location: Poway, Ca
Schedule: M-F 8am-5pm
Compensation: Midpoint 130K + Bonus and Benefits
*please note this is the midpoint, flexibility depending on
experience
Type: Direct/Permanent
Start date: Immediate
The 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
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