This position will report into the Associate Director of Quality responsible for the oversight and management of the Quality Systems at the site. This individual will be responsible for managing portions of the quality system program development, implementation, continuous improvement and/or harmonization at the Lexington Manufacturing Site. Use of project management collaboration skills is essential for program success.
The individual in this position will be a high level contributing member of the Quality Systems Team and will execute responsibilities with minimal management oversight. This individual will work to ensure the health of the Quality Systems at the site is maintained. Ensures that all Quality Systems are established and executed on Site within the area of responsibilities. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance. Escalation mechanisms as defined in Site Regulations are being adhered to.
This role works to build, enhance, harmonize and manage the quality systems at the site and is responsible for finding solutions and coordinating changes associated with the solutions.
This role will have responsibilities in some of the following areas:
- Execution of APQR and related activities
- Manage/perform execution lead responsibilities for the site as appropriate
- Provide Quality System guidance and troubleshooting to the site, as needed.
- Partner with management and other functional areas to project manage more complex and technical issues at the Lexington Site.
- Participate in and lead Quality Management Review and related activities
- Partner with Quality management to proactively address and resolve more complex and technical projects at Mass Bio Ops.
- Represent Mass Bio Ops in QMS Integration Activities
- Quality KPI Reporting and Continuous Improvement
- Coach and mentor individuals within the Quality department to ensure continued quality and compliance mindset.
- Represent Quality Systems during internal audits and regulatory agency inspections
- Manages ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas and staff in the successful performance of these activities.
- Drives continuous improvement and Lean Culture.
Education and Experience Requirements:
Essential: A minimum of a B.S. degree in science or engineering with at least 8+ years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. Prior supervisory experience desired.
Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Desired: Direct Biologic Pharmaceuticals experience
Location/Region: Lexington, MA