Integra LifeSciences
Vice President, Quality Compliance
Integra LifeSciences, Princeton, New Jersey, us, 08543
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION The VP, Quality Compliance is a key member of the Quality Leadership Team (QLT) with responsibility to design, implement and oversee quality and compliance improvement and remediation strategies across Integra LifeSciences. This role will implement the Compliance Master Plan (CMP) through a cross-functional leadership team across 14 manufacturing facilities and a diverse portfolio of leading medical devices and be responsible for building infrastructure that supports continued compliance across Integra manufacturing 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.
SUPERVISION RECEIVED Reports to the Chief Quality Officer
SUPERVISION EXERCISED Directly manages a PMO, indirectly manages all workstream leads for the enterprise Compliance Master Plan.
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows:
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 14 manufacturing 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 Compliance Master Plan (CMP) for Integra globally, requiring cross-functional collaboration and understanding of various roles within the organization. Leads both internal employees and external consultants in seven primary remediation workstreams at both a global and local site level. The seven workstreams include Management Responsibility, CAPA, Design Controls, Document/Change Control, Product and Process Controls, Facility & Equipment Controls, and Material Controls.
Communicate effectively with internal and external parties regarding quality initiatives and remediation progress. Provide regular status updates on the Compliance Master Plan to key stakeholders including divisional management, executive leadership and board of directors.
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.
DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor's degree is required, in engineering, science or closely related technical discipline is preferred. A Masters degree 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.
Ability to travel up to 50% if needed based on site needs. Regular on-site presence in Massachusetts and New Jersey facilities.
INTEGRA LEADERSHIP CAPABILITIES As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.
Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.
Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.
Drive Performance: Leaders with this capability drive performance and accountability through others and self.
Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
#J-18808-Ljbffr
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION The VP, Quality Compliance is a key member of the Quality Leadership Team (QLT) with responsibility to design, implement and oversee quality and compliance improvement and remediation strategies across Integra LifeSciences. This role will implement the Compliance Master Plan (CMP) through a cross-functional leadership team across 14 manufacturing facilities and a diverse portfolio of leading medical devices and be responsible for building infrastructure that supports continued compliance across Integra manufacturing 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.
SUPERVISION RECEIVED Reports to the Chief Quality Officer
SUPERVISION EXERCISED Directly manages a PMO, indirectly manages all workstream leads for the enterprise Compliance Master Plan.
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows:
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 14 manufacturing 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 Compliance Master Plan (CMP) for Integra globally, requiring cross-functional collaboration and understanding of various roles within the organization. Leads both internal employees and external consultants in seven primary remediation workstreams at both a global and local site level. The seven workstreams include Management Responsibility, CAPA, Design Controls, Document/Change Control, Product and Process Controls, Facility & Equipment Controls, and Material Controls.
Communicate effectively with internal and external parties regarding quality initiatives and remediation progress. Provide regular status updates on the Compliance Master Plan to key stakeholders including divisional management, executive leadership and board of directors.
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.
DESIRED MINIMUM QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor's degree is required, in engineering, science or closely related technical discipline is preferred. A Masters degree 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.
Ability to travel up to 50% if needed based on site needs. Regular on-site presence in Massachusetts and New Jersey facilities.
INTEGRA LEADERSHIP CAPABILITIES As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.
Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.
Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.
Drive Performance: Leaders with this capability drive performance and accountability through others and self.
Enable Talent: Leaders with this capability strive to engage, support, and develop self and others, optimizing the success of individuals and teams.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
#J-18808-Ljbffr