Director, Quality Compliance – Supplier Controls

Industry:

Company: Integra LifeSciences

Changing lives. Building Careers.

Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The Director, Supplier Controls is the Compliance Master Plan (CMP) Quality Management System (QMS) team leader with responsibility to design, implement and oversee quality and compliance improvement and remediation strategies for quality agreements, SCARs, supplier approvals, classification, Approved Supplier Lists, supplier monitoring and audit, supplier qualifications workstream. This role will be responsible for leading a team of individuals and partnering with global quality leaders to develop processes that result in attaining the company’s improvement objectives and growth strategies across 14 manufacturing facilities and a diverse portfolio of leading medical devices. 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Drive standardization & deploy world-class solutions to drive improved quality and compliance.

• Recognized as a leading expert and internal thought leader in Supplier Controls with highest level knowledge and broad, comprehensive knowledge of other QMS disciplines. Leads major improvements to existing processes and develops or champions new systems, concepts, procedures to solves unique and complex problems that have a broad impact on the business.

• Evaluate new regulations, guidelines and industry standards and their impact on CMP QMS Workstream processes; plan and effectively implement plans across the business to maintain compliance.

• Establish a Global Supplier Quality Controls program, including governance and oversight, to ensure compliance and consistency in areas of investigation, effectiveness, timeliness, quality and thoroughness of content. This includes but is not limited to quality agreements, SCARs, supplier approvals, classification, Approved Supplier Lists, supplier monitoring and audit, supplier qualifications. Collaborate with process owners and stakeholders in corporate, division and site to ensure the program is compliant, executable, and meets user needs.

• Ensure compliance of all process and digital improvements with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, EU MDR and JPAL.

• Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / system improvements, identify and implement opportunities.

• Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure synergy and strengths across the global teams.

• Provides strategic direction and communication of the CMP QMS workstream goals, directives, and policies to employees, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability.

• Demonstrates technical leadership as an inter-departmental resource coaching and teaching other Integra Leaders across all functions and geographies.

• Perform other related duties as expected.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and experience required for this position.

• Bachelor’s Degree in Engineering, or Sciences or relevant Technical Field required. Masters degree preferred.

• Minimum 15 years of experience in quality, manufacturing, or engineering, or equivalent education and years of experience

• Strong experience leading deployment of enterprise quality management solutions

• Experience in FDA controlled environment.

• Strong collaboration skills and experience working in a matrix environment.

• Ability to interface with technical and non-technical personnel.

• Knowledge of current Good Manufacturing Practices (cGMP), FDA, ISO, MDSAP, EU MDR and other applicable standards and regulations.
• This position could require up to 50% travel.
• Some of the responsibilities take place in a laboratory environment. This can require frequent sitting, walking, standing, occasional climbing, stooping, kneeling, and crouching.

TOOLS AND EQUIPMENT USED

• Power BI, mini-tab, Visio, and other process improvement tools.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

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.

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