Vice President, Corporate Quality Systems

Integra LifeSciences•Columbia, MD

3d•$225,400 - $316,250•Onsite

About The Position

The VP, Corporate Quality Systems is a key member of the Quality Leadership Team (QLT) with responsibility to design, implement and oversee the Integra Global quality system, including identifying compliance improvement and remediation strategies across Integra LifeSciences. This role will work cross-functionally across all Integra facilities to build an integrated Quality system infrastructure that supports continued compliance across Integra sites. This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.

Requirements

Bachelor's degree is required, in engineering, science or closely related technical discipline is preferred.
18+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience
Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation experience
Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
Experience with direct contact with FDA and EU Notified Bodies.
Knowledge of process design and implementation, change control, auditing, and document management systems required, general knowledge of statistical analysis preferred.
Demonstrated organizational, management and communication skills.
Proven track record of cross-functional collaboration across teams and change management skills.
Strong ability to influence across all levels of the organization, including senior leadership.
Experienced with interacting with Executive leadership to execute decisions and manage risk.
Ability to travel up to 50% if needed based on site needs.
Regular on-site presence in Massachusetts and New Jersey facilities.

Nice To Haves

A master’s degree preferred.
general knowledge of statistical analysis preferred.

Responsibilities

Build a high-performance quality culture and team, empowering and holding direct reports and cross-functional teams accountable for successful quality and compliance transformation. Leads with authority and influences globally across manufacturing and distribution facilities and cross functional stakeholders including but not limited to quality, product development, process technology, operations, supply chain, procurement, regulatory affairs, finance, and human resources.
Develop organizational design and governance to achieve success. Provide strategic direction and communication of the quality transformation goals, creating a clear vision and integration with overall business objectives. Develop and monitor key performance indicators (KPIs) to assess the effectiveness of quality and compliance remediation. Highlighting trends, risks, and opportunities for improvement.
Leads the design, execution and evolution of the Global Quality System for Integra in conjunction with the Compliance Master Plan (CMP) team, requiring cross-functional collaboration and understanding of various roles within the organization.
Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards. Responsible for leading the team with the review and finalizing any responses to regulatory authorities in collaboration with the Chief Quality Officer.
Lead the identification, analysis, and resolution of quality issues and non-conformities across various departments in collaboration with the Quality Systems and CAPA teams. Ensure remediation efforts are managed through the QMS.
Foster a culture of quality and continuous improvement within the organization. Promote the use of lean and Six Sigma methodologies to enhance quality and operational efficiency. Stay abreast of industry trends and advancements in quality management and remediation practices.
Guide the activities required of the quality organization to ensure compliance with all appropriate regulations and standards, including FDA Part 820, ISO 13485, CMDR, MDR, MDSAP, and JPAL. Ensures compliance and readiness globally in collaboration with the QMS.