Associate Director Quality Global Risk Management

Fresenius Medical Care • Waltham, MA

4d

About The Position

PURPOSE AND SCOPE: Responsible for developing, implementing, and maintaining risk management processes and tools within the global quality management system, in compliance with global regulatory requirements. Also responsible for supporting global teams in executing and implementing improvements and efficiency. Works in collaboration with colleagues from R&D, Post Market Surveillance (PMS), Pharmacovigilance (PV), Medical, Manufacturing, Regulatory Affairs, and Quality. PRINCIPAL DUTIES AND RESPONSIBILITIES: Lead a cross-functional team to develop, implement, monitor, and improve a global risk management program that manages product safety risk in accordance with ISO14971, applicable pharma risk standards, and applicable regional standards. The Risk Management process covers the entire product lifecycle from pre-market to post-market activities. Participate in implementing/maintaining a risk-based approach throughout the quality management system. Serve as Global Process Owner for the safety risk management program, responsible for procedures, work instructions, and tools. Responsible for related business processes and ensuring they are clearly defined and comply with applicable regulations (21CFR 820.30, ISO13485, etc.). Ensure appropriate interface with cybersecurity risk management processes and results. Provide in-depth risk management expertise and communication/guidance on execution throughout the product lifecycle. Develop, implement, and maintain risk management KPIs and monitoring program to ensure risk management documentation is developed and maintained in accordance with procedures and relevant market standards. Development of a risk management leadership forum that includes medical, R&D, and post-market users and stakeholders. Work with senior management to maintain a compliant and effective medical device risk management system and organization that meets the needs of the business. Development of a sustainable risk management infrastructure model to support global product quality in design. Develop risk management training and qualification programs that continuously improve and develop skills within the multidisciplinary Safety Management Team. Develop strategies to ensure the Risk Management element is robust, improves compliance, meets regulatory and corporate guidelines and obligations, and achieves measurable gains in reducing risk to patients and increasing customer satisfaction. Provide leadership, guidance, and coaching to foster an engaged and productive workforce. Actively coordinates with management in the daily oversight and execution of global risk management. Provides training to staff regarding global risk management processes. Support external and internal audits, related to risk management. Takes a lead collaborating with management in regulatory inspections. Oversee the transfer of legacy FMEA and risk management analyses into the global tool in accordance with program/project plans. Assists with various projects as assigned by management. Other duties, as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. SUPERVISION: Responsible for the direct supervision of various levels of staff.

Requirements

• Bachelor’s Degree required, preferably in Science, Engineering, Technical, or Healthcare related field. Advanced Degree desirable.
• Minimum of 10+ years total experience working with medical devices and pharmaceutical products, related to risk management, or equivalent relevant experience.
• 3+ years’ supervisory or project/program management experience preferred.
• Extensive ability to make risk-based quality decisions to ensure patient needs are met.
• Expert knowledge of ISO13485 and ISO14971 standards and their application in global markets.
• Ability to make the link between business strategy and execution transparent so team members understand how project success equates to business success.
• Excellent ability to build consensus and trust in decisions, address conflicts or resolve conflicts quickly and fairly, even during critical phases of a project.
• Proven ability to lead multiple complex teams and initiatives consisting of numerous team members with multiple, diverse skills, experiences, knowledge profiles and professional backgrounds.
• Excellent interpersonal skills and ability to communicate with all levels of management through diplomacy and tact.
• Ability to communicate technical information to non-technical audiences.
• Proven leadership experience, including talent management, recruitment, retention and development.
• Has the capacity to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Attention to detail required and ability to make decisions with limited information.
• Prior experience working with the FDA and other global regulatory bodies, specifically EU.
• Must have excellent, concise writing skills, including excellent communication, interpersonal skills and experience in working in multidisciplinary teams.
• Has the ability to work independently with minimal supervision, multi-task with attention to detail, is able to manage multiple projects under tight deadlines, independently identify problems and effectively offer solutions.
• Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities

Nice To Haves

• Advanced Degree desirable.
• 3+ years’ supervisory or project/program management experience preferred.

Responsibilities

• Lead a cross-functional team to develop, implement, monitor, and improve a global risk management program that manages product safety risk in accordance with ISO14971, applicable pharma risk standards, and applicable regional standards.
• Participate in implementing/maintaining a risk-based approach throughout the quality management system.
• Serve as Global Process Owner for the safety risk management program, responsible for procedures, work instructions, and tools.
• Responsible for related business processes and ensuring they are clearly defined and comply with applicable regulations (21CFR 820.30, ISO13485, etc.).
• Ensure appropriate interface with cybersecurity risk management processes and results.
• Provide in-depth risk management expertise and communication/guidance on execution throughout the product lifecycle.
• Develop, implement, and maintain risk management KPIs and monitoring program to ensure risk management documentation is developed and maintained in accordance with procedures and relevant market standards.
• Development of a risk management leadership forum that includes medical, R&D, and post-market users and stakeholders.
• Work with senior management to maintain a compliant and effective medical device risk management system and organization that meets the needs of the business.
• Development of a sustainable risk management infrastructure model to support global product quality in design.
• Develop risk management training and qualification programs that continuously improve and develop skills within the multidisciplinary Safety Management Team.
• Develop strategies to ensure the Risk Management element is robust, improves compliance, meets regulatory and corporate guidelines and obligations, and achieves measurable gains in reducing risk to patients and increasing customer satisfaction.
• Provide leadership, guidance, and coaching to foster an engaged and productive workforce.
• Actively coordinates with management in the daily oversight and execution of global risk management.
• Provides training to staff regarding global risk management processes.
• Support external and internal audits, related to risk management.
• Takes a lead collaborating with management in regulatory inspections.
• Oversee the transfer of legacy FMEA and risk management analyses into the global tool in accordance with program/project plans.
• Assists with various projects as assigned by management.

Benefits

• This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level