The role
Sr. Program Manager, Quality Program Management is primarily responsible for the direction, coordination, implementation, control and completion of Quality System Alignment and Integration projects for the company and other Quality & Regulatory programs that have significant business impact. Responsibilities include managing the planning and implementation of the company quality management system (QMS); quality system integration; creation and implementation of corporate processes, process maps, procedures and tools, re-branding, support new/upgraded product launch, remediation, etc. This role also has the potential to expand to lead new product development, sustaining engineering, business acquisition integration, business expansion, etc.
The Sr. Program Manager, Quality Program Management will work closely with cross functional leaders, and Quality Leadership to ensure alignment with strategy, commitments, and goals of the organization. The Sr. Program Manager will provide project management guidance for other key quality system initiatives or projects, working closely with upper management to make sure that the scope and direction of each project is on schedule, as well as other departments for support. They also partner with corporate and site leadership globally to ensure that alignment and integration activities are conducted in a way that meets relevant procedures and external regulations.
ESSENTIAL DUITES & RESPONSIBILTIES
- Develops, plans, and leads Quality System due diligence and integration activities for acquisitions.
- Works with cross functional and cross quality teams to ensure all elements of a project are understood and delivered.
- Broad knowledge of applicable regulations and standards (e.g., QSR, ISO 13485, MDD/MDR) and how to apply the principles, practices, and procedures
- Provides leadership and influence among multiple departments and teams such as Engineering, Quality & Regulatory Affairs, and Operations to ensure specific program metrics are met.
- Manage the planning and implementation of the Quality Management System (QMS), including the creation and implementation of corporate processes, process maps, procedures, and tools in compliance with all applicable industry, local, national, and international regulatory requirements, and standards.
- Manage Quality & Regulatory programs for remediation, re-branding, etc. that have significant business impact
- Establish and use the Integration and Diligence quality playbook
- Report out on project progress.
- Work with Finance to develop and effectively manage operating, staffing, and capital projects budgets.
- Reports directly to Director of Quality & Regulatory Affairs. Supervises, trains, and assists all quality team personnel. Directs quality-related activities in conjunction with Manufacturing, Engineering, Supply Chain, Customer Service, and any otherdepartment/function that affects the quality of the organization’s goods or services.
- Ability and willingness to travel 30%
- All other duties and responsibilities as assigned
Qualifications
- Bachelor’s degree required, preferably in a scientific or engineering discipline, or Business Administration/Management.
- Strong Preference: Certified Project Management Professional (PMP), or Business Administration (MBA)
- 10+ years of experience in Project/Quality Management in a manufacturing, preferably medical device, aerospace, or highly regulated industry including FDA, CFR, and ISO compliance
Knowledge/Skills that will enable success
- Strong analytical, strategic, decision-making abilities.
- Excellent organizational, leadership, and interpersonal skills.
- Excellent communication skills and the ability to work well with people (internal/external) at all levels are essential.
- Capability of working independently, taking ownership for the management of processes, projects and timelines.
- Proficient in the following computer software applications Microsoft Office, Project
- Strong organizational and communication skills (written and verbal).