Integra LifeSciences Director, Quality Operations/Manufacturing in Plainsboro, New Jersey
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Director, CMC Quality Operations serves as the leader of Orthopedics & Tissue Technologies Collagen Manufacturing Center (“CMC”) Quality Operations department and the position is accountable and responsible for the strategic leadership, management and direction of the CMC Quality functions. 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 CMC Quality Operations 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, CMC 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, CMC 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 CMC 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 CMC 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.
Bachelor’s degree in a scientific or biotechnology field
Minimum of 15 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 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
Vacancy ID 2018-26847
Position Type Regular Full-Time
Category Quality Assurance