Associate Director, Quality Control

Role Summary

We are seeking an Associate Director, Quality Control. The Associate Director, QC, acts as senior leadership for the Quality Control operation at Lantheus’ Evergreen site. This position will oversee and lead the QC department at Evergreen, ensuring a compliant, efficient operation that can meet internal and external needs for quality radiopharmaceutical products. This role is the primary accountable person for the success of QC operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance, and will review and author key CMC submissions and set standards for analytical operations. This position is based in New Jersey with on-site presence three days per week.

Responsibilities

• 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 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 Lantheus‚Äô 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 ‚Äòsending‚Äô 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 Lantheus‚Äô values.

Qualifications

• Required: A B.S. in relevant scientific/technical disciplines; advanced degrees (e.g., MS) or technological certificates preferred but not required.
• Required: 10+ years experience in a GMP Quality Control Environment.
• Required: 5+ years experience in people management and conflict resolution.
• Required: 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections.
• Required: 2+ years in the radiopharmaceutical industry (preferred but not required).
• Required: Prior experience with managing a microbiology department (preferred).
• Required: Prior experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management (strongly preferred).
• Required: Travel may be required and is dictated by product needs and project deliverables, including overnight travel to CDMO locations.
• Required: Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

• Preferred: SME in analytical test methods and analytical technology; strong knowledge of global regulatory requirements.
• Preferred: Knowledge of SOPs, cGMPs, GCPs and GLPs; ability to work within a regulatory environment.
• Preferred: Experience with technology transfer and scale-up programs for commercial drug product analytical processes.
• Preferred: Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts.
• Preferred: Excellent organizational skills and ability to manage multiple technical projects in a fast-paced environment.
• Preferred: Proactive leadership, facilitation, teamwork, and negotiation skills.
• Preferred: Understanding of FDA and/or EMEA quality and regulatory processes; experience with regulatory filings is highly desired.
• Preferred: Experience working with external partners.
• Preferred: Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Preferred: Independent judgment, tactful discretion, and attention to detail with awareness of the big picture.
• Preferred: Proficiency with Microsoft Word, Excel, PowerPoint, and Project; ability to represent Lantheus and the Evergreen site to external organizations with integrity and professionalism.