Serve as the leader of Quality Operations in Boston and Mansfield manufacturing locations and the position is accountable and responsible for the strategic leadership, management and direction of both locations. Engage and develop a best in-class quality team, ensuring that the organizational structure, talent and resources are aligned with key business imperatives and delivers results with a commitment to excellence and a dissatisfaction with the status quo. Assure the development of targeted short and long-term programs to maximize product quality and availability thereof, and to improve demand planning as a basis for competitive advantage. Provides continuous support, training, mentoring, and development to ensure performs at a maximum performance level.
This leader shall demonstrate business quality acumen and sound decision making by setting direction and making informed, fact-based decisions that enhance quality, financial and operational performance. The Director, Quality Operations will apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues and enjoy the challenge of managing a team across a matrix organization.
The Director, Quality Operations shall create a culture of high-performance and holds self and others accountable and enforces high standards, while demonstrating tact and diplomacy and making difficult or unpopular decisions for the good of the business. The Quality leader would create an environment in which creativity and innovation are the norm and change is not only accepted but encouraged by championing innovation and change.
The Quality leader will be responsible for the continual state of inspection readiness, managing and oversight of the inspection (internal & external) process and facilitating interface with regulators and managing responses, if necessary.
- Provide leadership and ensure the operational success of quality functions with an emphasis on product quality, prevention, continuous improvement, and customer satisfaction.
- Continuously evaluate effectiveness of quality functions to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management. Implement metrics and KPIs that demonstrate the effectiveness, timeliness and the accuracy of the Boston and Mansfield Quality functions, in addition to standard quality business performance metrics (i.e. Productivity, Efficiency, Capacity utilization rate, First Pass Quality, Resource Utilization %)
- Host and manage cGMP inspections; ISO audits. Ensure continuous Boston and Mansfield audit readiness.
- Ensure all activities and operations are carried out in compliance with local, state, federal, and international regulations and laws governing the quality operations
- Responsible for the collection and reporting of metrics and data to Division, Facility and Department Management per defined schedules or ad hoc when required to communicate involvement and results of quality engineering activities. Responsible for reviewing data and metrics and taking or proposing appropriate action, as required. Develops creative solutions to problems as they arise.
- Bachelor's degree in a scientific or biotechnology field
- Minimum of 10 years pharmaceutical and/or medical device industry experience
- Including 5 years managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Six Sigma Black Belt Certification strongly preferred
- Strong understanding of 21 CFR, ICH Q7-Q10, E6 and ISO13485
- Progressive management experience is strongly preferred
- Supervisory/management capacity in a cGMP/clean room environment is required.
- Hosting/Facilitating Regulatory Inspections is strongly preferred.
- Demonstrated ability to:build high levels of engagement throughout a plant environment.
- build a superior leadership team and bench.
- develop and maintain key internal and external professional relationships.
- generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency.
- quickly gain the respect and support of own staff and fellow leaders.
- build customer relationships with Integra LifeSciences' partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
- Be/think/act positive
- Be accountable
- Be results oriented
- Excellent written and verbal communication skills
- Excellent organization and interpersonal skills
- Exemplifies Leadership Integrity and Courage
- Ability to travel up to 10% of the Time