Associate Director Quality Assurance
1 week ago
Overview
The Associate Director, Quality Assurance, Release, is a newly created position that requires a highly independent individual with strong communication skills.
The position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Quality, with the goal of optimizing informed decision making. The position will be fluent in release processes and procedures.
Monday to Friday-standard hours.
Essential Functions and Responsibilities
- Lead team of Quality professionals to support routine release of raw materials, critical reagents, and TIL Drug Product materials in support of clinical and commercial operations.
- Responsible for QA release of internal manufacturing, raw materials, and components.
- Ensure appropriate and timely escalation of significant quality issues
- Manage batch record review.
- Approval of documentation from 3rd party warehouse as needed.
- Manage lot closure.
- Manage lot release and disposition activities
- Manage Raw material release, Component release, and kit release as required to support manufacturing
- Lead or provide strong support for investigation of deviations, nonconforming events, and corrective action/preventative action investigations
- Drive continuous improvements to systems, policies, procedures, and ways of working to create a more efficient release process that is agile, nimble, compliant, and meets the needs of the business to serve autologous cell therapy patients
- Support Change controls and other Quality System records
- Develop and establish SOPs as needed for product release
- Approve label specifications
- Review quality records and documentation for approval including master records, procedures
- Develop and maintain training matrix for release team
- Manage final product label issuance.
- Identify, propose, and help implement procedural changes aimed at improving product quality
- Ensure knowledge sharing and collaborative troubleshooting
- Provide support for audits as required
- Track and report on Quality Release metrics as required
- Other duties as assigned
Required Education, Skills, and Knowledge
- B.S. degree in science. Advanced degree a plus.
- At least 10 years of experience in the pharmaceutical/biotech industry, with at least 6 years in a commercial manufacturing environment working in cell therapy or biologics release of drug product and materials. a minimum of 5 years supervisory experience required.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative position.
- Experience with label issuance for final drug product
- Experienced in troubleshooting, investigations, problem solving and in negotiating the path forward with multiple functions to ensure timely product release.
- Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.
- Ability to simultaneously manage multiple projects
- Ability to follow through on all activities to ensure projects are completed as planned.
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Able to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment:
- This position will work in both an office and a manufacturing setting.
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