The Quality Assurance Manager provides functional and technical management to Quality Engineers for internal manufacturing operations.
- Ensure staff members' activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements. Ensure a state of inspection readiness and meet business objectives. Manage the activities and performance of direct staff; this includes hiring, training, developing, addressing performance issues and evaluating performance.
- Develop action plans, initiate, and employ training/development programs and assignments to further enhance technical skills and overall competencies of staff members.
- Provide technical direction, support and guidance for projects, qualifications and validations.
- In depth technical knowledge of Risk Management, GAMP5, Data Integrity, etc.
- Oversee the Investigational Review Board. Consult and advise staff on investigations to ensure investigation drives to root cause(s) utilizing appropriate tools (Fishbone, Cause Map analyses, etc.) ensuring investigation is through and effective CAPA(s) are implemented.
- Prepares, maintains and reviews internal policies, procedures, technology, systems, and processes, and all related federal and international regulatory requirements and guidelines.
- Ensure operations are within budget and cost savings initiatives. Knowledge and utilization of Continuous Improvement tools (Value stream mapping, Process mapping, etc)
- Assist in monitoring and driving key performance quality metrics.
- Ensure quality directives and policies are effective and implement action to ensure compliance.
- Maintain, monitor and report out on the QA oversight program.
- Participate during internal audits and external inspections conducted by regulatory bodies. Ensure timely responses to noted observations and identify root cause for observations. Implement and monitor CAPAs to ensure their timely completion.
- Interface with auditors from regulatory agencies and customers during in-plant inspections in relation to product testing. Assist in completion of any commitments made (Observations and CAPA's) to regulatory agencies.
- Participate on internal and external project teams, or programs.
- Make decisions which effect product quality, regulatory compliance and the quality of product in the market place.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- BS/BA degree in a relevant scientific discipline and a minimum of 7-10 years progressive Quality Engineering experience in the pharmaceutical industry, or equivalent.
- May require handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
- Non-routine, overnight travel based on business need.