Senior Director, Global Quality Assurance

Job Description

Job Description

Job

DescriptionBrioHealth

Solutions, Inc. is seeking a experienced and passionate leader to join our team as Sr. Director, Global Quality Assurance & Quality Systems. This high-level leadership role requires a highly experienced leader ready to develop, manage, and improve the Quality Management System for BrioHealth Solutions. This role will lead and guide the appropriate quality assurance and quality system governance and controls across all areas of our global business to ensure effectiveness and ensure continuous improvement. This functional leader will use deep experience in a variety of areas to work closely with cross-functional teams and stakeholders to drive operational excellence, deliver strategic initiatives, and maximize the value and efficiency of our quality and operational investments. Candidates will possess a track record of delivering exceptional operational results in a fast paced and complex global environment. They will apply emotional intelligence to mentor and guide cross-functional teams while achieving corporate and functional objectives. Leadership qualities must include the ability to influence colleagues, challenge peers and make critical decisions. This leader guides and leads the long-term strategy of the global quality assurance, quality systems, change control, audits, and other QMS teams.Expected behavioral qualities include a positive outlook and affinity for teamwork, logic, communication, innovation, and initiative with a demonstrated ability to establish trust, credibility, motivation, control, mentorship, sponsorship, and influence within cross-functional teams. Accountability for meeting quality, schedule, and cost goals are essential, as is dependability and

adaptability.Responsibilities

From this Sr. Director, Global Quality Assurance & Quality Systems, the following, at a minimum, will be required: Global Quality Management System Strategy & Execution: Operational and functional expert with broad experience in the field of Quality System Management to establish and maintain a risk-based and fit-for-purpose global quality management system. Ensure the effective and efficient implementation and maintenance of the quality system while driving continuous improvement and remaining in compliance with both current and evolving global health authority requirements and regulations. Lead, sponsor, and provide oversight to diverse and complex projects and cross-functional teams to drive improvement and performance of quality processes while ensuring proper documentation and records management. Ability to anticipate the need for and facilitate or lead quality assessments, deep dives, or other reviews as appropriate within the global quality function. Drive the strategy necessary for infrastructure and capability development in support of excellence within the quality assurance and quality systems areas. Stay abreast of emerging regulations, standards, technologies, and trends while making recommendations related to the deployment of key solutions. Oversee the mitigation of risks and issues through effective problem-solving and decision-making. Drive innovation in processes, technologies, and methodologies to enhance operational performance and drive beneficial outcomes. Quality Assurance Leadership: Guide and support quality management review activities and oversee trending of key quality management system metrics. Report and escalate compliance issues to management. Develop, implement, and communicate quality policies and procedures to ensure consistency and compliance across the reginal operations. Develop processes and guidelines to optimize the performance of these teams as part of the new product development and quality management system procedures. Assess regulatory compliance risk and develop, implement, and improve risk mitigation measures with the accountable team members. Provide input in quality digitization strategies and support the implementation in a way that meets both regulatory compliance and business needs. Responsible for establishing quality procedures, conducting internal audits, managing document control and oversight over training programs. General Quality Operations Additional leadership and support of functional groups including quality assurance, document control, internal audits, employee training, and other quality teams may be required. This position will play a key role in building this organization which may include strategy, planning and initial execution of broader manufacturing, quality, and operational roles before the team grows to a level where handoff of these responsibilities are appropriate. Specific duties and qualifications may vary depending on the needs of the organization. This list is not exhaustive of the possible quality responsibilities of the role. Team Development and Leadership: Lead the development of functional best practices and processes to improve efficiency, facilitate functional initiatives, and deliver operational excellence. Champion excellence thru robust quality frameworks, methodologies, and tools. Manage and lead a team of managers, directors, and supporting staff members within the Global quality department both in the USA, China, and future office locations. Provide guidance, set clear expectations, and support the staff while fostering a collaborative, creative, and innovative work environment. Leadership qualities must include the ability to mentor colleagues and make critical judgments and decisions. Effective, persuasive communication of work product to the entire organization. Responsible for talent management within your department including: Identifying skill, capability, and infrastructure gaps Recruiting top talent Providing training and development opportunities Conducting meaningful performance evaluations Supporting the career and capability development of the team Managing team issues including performance management or other HR related items Resource Allocation and Project Execution: Engage with senior leadership and key stakeholders to communicate objectives, progress, and performance. Collaborate with business units and functional teams to ensure alignment between project initiatives and organizational strategies. Foster strong relationships with internal and external stakeholders, promoting collaboration, transparency, and effective communication. Oversee the successful execution of strategic programs and projects, ensuring adherence to quality standards, timelines, and budgetary constraints. Oversee project teams, fostering a culture of accountability, collaboration, and continuous improvement. Budget Management: Oversee resource allocation across the global quality assurance and quality systems teams, ensuring the availability of skilled talent to drive project success. Collaborate with finance and budgeting teams to develop and manage budgets, monitoring expenditures and financial performance. Select and drive opportunities for cost savings, efficiencies, and process improvements within the global operation. Requirements

Long experience totaling more than 20 years of progressive leadership experience (or an advanced degree plus more than 15 years of related experience) in a highly regulated environment with deep knowledge of quality assurance and highly functional quality systems. Hands on experience in second/third party audits for Class III medical devices is highly preferred. In-depth knowledge of GMP and global regulations, principles, concepts, practices, and standards. Strong understanding of production, manufacturing and operational KPIs is desired. Proven ability to deliver strategic plans, manage change, and drive organizational transformation. Exceptional leadership and people management skills, with the ability to influence, inspire, and motivate cross-functional teams. Excellent communication and stakeholder management abilities, with the capability to interact with individuals at all levels of the organization. Results-oriented mindset with a focus on continuous improvement and driving operational excellence. About BrioHealth Solutions BrioHealth Solutions, Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (BrioVAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.

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