Senior Director, Quality Compliance Program Management

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.

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 objectives, timelines, risks, and impact on business operations. Ensure transparency and accountability.

DESIRED MINIMUM QUALIFICATIONS

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

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Business Administration, or a related field. Master’s degree or MBA preferred.
• Relevant certifications (e.g., PMP, Six Sigma, CQE) a plus.
• Minimum of 15 years of experience in quality, operations or program management with at least 4 years in a leadership role managing large, cross-functional programs.
• Experience leading quality and regulatory compliance programs in medical devices or highly regulated industries preferred.
• Extensive experience in leading global remediation programs, addressing regulatory gaps, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR.
• Proven track record of successfully managing large-scale programs, mitigating risks, and delivering high-quality results.
• Strong background in CAPA, root cause analysis, and regulatory submissions.
• Strong leadership and team management skills, with the ability to lead cross-functional teams and manage stakeholders at all levels.
• Excellent project management skills, including the ability to create and manage complex project plans, timelines, and budgets.
• In-depth knowledge of medical device regulatory requirements (FDA, ISO 13485, EU MDR) and industry best practices for quality management and compliance.
• Excellent problem-solving and analytical skills, with the ability to think strategically and manage complex, high-stakes situations.
• Exceptional communication and presentation skills, with the ability to articulate program status and risks to senior leadership and external stakeholders.
• Ability to navigate regulatory environments and maintain compliance with a focus on continuous improvement and operational excellence.
• This position could require up to 50% travel.

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.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order 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.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, write/type, and move through all locations of a manufacturing facility. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Must be able to independently travel via car or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position. Some of the responsibilities take place in a laboratory environment. This can require frequent sitting, walking, standing, occasional climbing, stooping, kneeling, and crouching.

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.

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