This position reports directly to the Director, Quality for the Quincy, MA. Distribution Center. The position will manage Quality Systems, Documentation Control/Services departments and is responsible for implementing and maintaining the Quality System in Quincy, including Quality Assurance mandates and sets policies and procedures for the Quality System within Quincy. This position will be responsible for the compliance of all Drug Wholesale activities that affect the site in order to maintain licensure and certifications. This position also m anages and reports on the Material Review processes and Quality Engineering activities in Quincy. This position will interface with other members of Management with respect to regulatory compliance initiatives, on-going compliance with all procedures and standards, as well as implementing continuous improvement initiatives. The incumbent will provide vision and leadership for strategic projects with significant impact within the Corporation. This person will act as a role model for change in the current Corporate culture. Work collaboratively across functions, regions and business units to implement project strategies and tactical plans to deliver results. Act as a champion of change in business practices. Manager must have an excellent understanding and working knowledge of GMP's (QSR) and ISO/MDD requirements.
- Manages all personnel, activities, initiatives and site specific programs, as well as, Corporate driven initiatives related to the Quality System, CAPA, Auditing - Internal/External and Supplier, Documentation Control and Services, Management Review and Drug Wholesale Licensure
- Responsible for all aspects of the Quality Systems Department within Quincy, including, but not limited to: Internal/External Audits, CAPA System, Management Review, and other related Quality System activities, including general maintenance of the quality system.
- Manage all aspects of the Material Review process. This included overseeing the execution, dispositioning, and reporting of all MRR activities.
- Manages all Quality Engineering activities.
- Sets policy and procedures for the QA at Quincy, in conjunction with other management in QA, including but not limited to; product release and systems which impact Quincy from other BSC facilities; interaction with both internal BSC sites and external customers.
- Sets policy and procedures for the Quality System in Quincy, in conjunction with the Director of Quality Assurance, Corporate QS and Compliance Groups, including systems which impact Quincy from other BSC facilities. Responsible for interacting with internal BSC sites and external customers, on Quality Systems related issues.
- Ensure the Quality System is substantially compliant to QSR and ISO. Work with Senior Management to identify areas of the quality system needing improvement. Audit site generated documents and reconcile discrepancies where appropriate. Maintain site compliance to external standards. Audit areas of non-compliance within the medical industry to evaluate any shortfalls for the site with respect to the company’s Quality System. Active member of the BSC Compliance Council and Quincy Management staff to drive continuous improvement throughout the Quincy facility.
- Performs other duties and projects as required.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
- Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
Boston Scientific Corporation - 23 months ago
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...