Senior Director, Quality Compliance Program Management

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.

The Senior Director is responsible for leading the program management of Integra’s Compliance Master Plan (CMP).  This strategic role is responsible for overseeing the planning, execution, and successful delivery of efforts to address quality and compliance gaps across the organization. The CMP Program Manager will be working alongside the VP, Quality Compliance to provide tactical and strategic oversight of the CMP program, including management of the program schedule. This role has responsibility to drive cross-functional collaboration to remediate non-conformities, enhance operational processes, and improve product quality across the company.  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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Program Leadership and Strategy

• Lead and manage the CMP, ensuring it aligns with company objectives and regulatory requirements.  Develop a comprehensive program strategy, including clear goals, milestones, timelines, and success metrics, ensuring alignment with corporate priorities.

• Oversee the integration of CMP efforts across multiple functions, such as manufacturing, regulatory, R&D, and quality assurance, ensuring full compliance and readiness for regulatory inspections.

Program Planning and Execution

• Define the scope, objectives, and deliverables for the CMP and communicate them effectively.  Develop and maintain detailed project plans, identifying key tasks, timelines, and resources required to address non-conformities and ensure compliance.

• Lead the risk management process to proactively identify and mitigate potential issues that could delay CMP activities or impact compliance.

• Monitor and report on program progress, ensuring that CMP actions are completed on schedule, within scope, and meet quality standards.

Cross-functional Collaboration and Stakeholder Management

• Collaborate with key functional leaders (e.g., Regulatory Affairs, Quality Assurance, Manufacturing, Legal, and Operations) to ensure alignment of efforts across all business units.

• Regularly update the executive leadership team and other key stakeholders on program status, risks, and issues, making recommendations for corrective actions when necessary.

Resource and Budget Management

• Lead the program’s resource planning, including staffing, budget management, and allocation of key resources across the organization.

• Develop and manage the program budget, ensuring cost-effectiveness and alignment with overall financial goals.

• Provide leadership and mentorship to program management teams, ensuring they have the skills and tools to deliver on the program’s objectives.

Reporting and Communication

• Provide senior leadership oversight for the program, ensuring timely and effective execution of CMP actions.  Create and deliver regular status reports and presentations on the progress of activities, risks, and overall program performance.

• Provide clear communication across all levels of the organization regarding program