Associate Director of Quality Control

Job Description

About Us

Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Purpose

The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance / decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.

Key Responsibilities / Essential Functions

• Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization.
• Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill.
• Define specific qualification standards for SMEs and the subsequent qualification processes.
• Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department.
• Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables.
• Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements.
• Oversee and manage departmental efficiency and proficiency to enable a lean operation.
• Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders.
• Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth.
• Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process.
• Leads, motivate, mentor, and develops team members to exceed and meet company goals.
• Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.
• Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.
• Report and take initiative to correct safety and environmental hazards.
• Actively demonstrate Evergreen Theragnostics’ values.

Typical Minimum Skills and Experience and Education

Other Requirements