Associate Director, Quality Operations

Codera•San Diego, CA

2d•$160,000 - $230,000•Onsite

About The Position

The Associate Director, Quality Operations has oversight of quality programs to support product realization and inspection readiness. The Associate Director supports the Senior Director, Quality Operations, in managing deliverables and timelines for multiple workstreams and entities. This includes service provision to clients, coordination with vendors and collaborating cross-functionally within the company. This individual ensures that deliverables, templates and timelines are maintained throughout product lifecycle from a quality perspective.

Requirements

Degree in any science related discipline
Minimum 10 years of experience in quality system implementation and/or execution of quality events across various pharmaceuticals or biologics
Minimum 6 years of experience in GxP service provision including management of various workstreams and/or customers
Previous experience with management of quality assurance and quality control systems including laboratories, document management and quality event management
Knowledge of GxP operations for clean rooms, facilities, and associated equipment
Ability to work in a dynamic environment with a high degree of flexibility
Previous audit experience
Strong critical thinking skills and ability to apply sound judgment and decision making based on risk and phase of development
Ability to manage multiple workstreams across multiple disciplines

Responsibilities

Perform vendor assessment of operational GxP systems (remote or onsite), including qualification and re-qualification.
Manage vendor inspection readiness program, including status for audit related CAPA and inspection readiness workstreams for GXP activities. This includes the review of updates and deliverables where required.
Utilize metrics and work plan to track and continually improve performance of quality operations workstreams.
Responsible for the review of API, Intermediate, labeled finished product and other Executed Batch Records and perform QA release of batches, including raw data review to ensure batch release requirements are met.
Classify, process and support deviation and complaint investigations and evaluate resulting corrective and preventive actions with vendors.
Develop and issues communications and reports to stakeholders as required.
Ability to communicate real-time quality information on all ongoing quality operations activities to senior management and stakeholders.
Develop procedures and other quality operations related documents to establish a library for multiple company types.
Develop and deliver presentations to internal and external audiences.
Coordinate the Quality Risk Management process throughout development and lifecycle management of the Product.
Prioritize ongoing Quality Risk Management efforts and assign appropriate team members to risk management activities in collaboration with technical leads, management, and project management.
Ensure that improvements in the risk assessment process are constantly identified, prioritized, and implemented.
Establish, implement, and maintain a system of work standards within the framework of site procedures and regulatory guidance.
Lead and/or support other projects as assigned