Associate Director, Quality Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Conduct assessments of vendors for operational GxP systems, either remotely or onsite, including both qualification and re-qualification processes.

• Oversee the vendor inspection readiness program, which encompasses the tracking of audit-related CAPA and inspection readiness workstreams pertaining to GxP activities.

• Leverage metrics and work plans to monitor and continuously enhance the performance of quality operations workstreams.

• Take responsibility for reviewing API, Intermediate, labeled finished product, and other Executed Batch Records, performing QA batch releases, including raw data reviews to ensure compliance with batch release criteria.

• Classify and manage deviation and complaint investigations, assessing the resulting corrective and preventive actions in collaboration with vendors.

• Develop and disseminate communications and reports to stakeholders as necessary.

• Capable of conveying real-time quality information regarding all active quality operations activities to senior management and stakeholders.

• Create procedures and other documents related to quality operations to build a comprehensive library for various company types.

• Prepare and present information to both internal and external audiences.

• Facilitate the Quality Risk Management process throughout the product's development and lifecycle management.

• Prioritize ongoing Quality Risk Management initiatives and allocate suitable team members to risk management tasks in partnership with technical leads, management, and project management.

• Ensure that enhancements in the risk assessment process are consistently identified, prioritized, and executed.

• Establish, implement, and sustain a system of work standards that align with site procedures and regulatory guidelines.

• Lead and/or assist with additional projects as assigned.

⛳️ Requirements

• A degree in a science-related field.

• At least 10 years of experience in quality system implementation and/or the execution of quality events within various pharmaceutical or biologic settings.

• A minimum of 6 years of experience in GxP service provision, including the management of numerous workstreams and/or customers.

• Prior experience in managing quality assurance and quality control systems, encompassing laboratories, document management, and quality event management.

• Familiarity with GxP operations related to clean rooms, facilities, and associated equipment.

• Ability to thrive in a dynamic environment that requires a high degree of flexibility.

• Previous audit experience is preferred.

• Strong critical thinking abilities and the capacity to apply sound judgment and decision-making based on risk assessments and development phases.

• Capacity to manage multiple workstreams across various disciplines.

• Willingness to travel domestically and internationally up to 20% of the time.

🏝️ Benefits

• Employer-sponsored insurance plans, including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.