About Us

Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, providing contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We have recently submitted our first New Drug Application (NDA) to the US FDA. We also operate our own cutting edge cancer research laboratories, developing proprietary, radiotherapeutic medicines. The company expects rapid growth in the next few years.

Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company.

Job Description

The VP, Quality Assurance supports the mission, goals, and strategic plan of Evergreen Theragnostics, Inc. through the evaluation, execution, and continuous improvement of the Quality Management System (QMS), quality assurance, quality control, and quality improvement initiatives throughout the organization. This includes assisting and managing the development, implementation, and monitoring of the quality system, the Quality Assurance Department, ensuring the highest quality standards and regulatory compliance, and setting and achieving departmental and organizational strategic goals and processes.

Responsibilities

1. Responsible for ensuring compliance with all regulatory standards for cGMP pharmaceutical manufacturing and remaining current with industry quality trends and best practices.
2. Act as primary quality liaison for all audits, surveys, and inspections.
3. Provide leadership in Quality Assurance across the organization.
4. Direct all aspects of the QMS including supplier qualification audits and assessments, product quality assessments, development and approval of Quality Agreements, document control and record retention, data integrity, batch review and release.
5. Manage the development and organization of the Quality Assurance department to maintain and improve quality operations while supporting a growing manufacturing operation, including:
6. Establishing and trending department key performance indicators (KPIs).
7. Establishing target staffing levels for each role.
8. Ensure timely batch release to support commercial and clinical-stage radiopharmaceutical supply.
9. Adherence to departmental budgets
10. Identification and evaluation of software tools and equipment needs to support expanded operational development and quality improvement.
11. Manage the training programs for internal personnel to permit right-first-time execution of required tasks and ensure compliance with regulatory requirements, policies, and standard operating procedures (SOPs).
12. Ensure timely management of Quality Events and investigations, including Deviations, Out-of-Specifications, Change Controls, and CAPAs.

Qualifications

1. 10+ years of experience in Quality Assurance.
2. Prior experience with radiopharmaceuticals preferred.
3. Experience and track record in managing quality systems for clinical-stage and commercial-stage manufacturing programs.
4. Up-to-date working knowledge of FDA and EMA regulations.
5. Ability to effectively organize and delegate effectively to team members, possess excellent time management, and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
6. Possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others in a positive and collaborative manner. Able to communicate with a sense of urgency to internal and external stakeholders.
7. Must be able to work effectively as a team member across internal departments.
8. Experience in Root Cause Analysis (RCA), Risk Management, cGMP, and ISO Standards.
9. Experience in auditing and FDA inspections.