The Sr. Technical Program Manager- Quality Regulatory Affairs will drive the success of complex, cross-functional programs in the Technology, Digital Health, and AI space, with a focus on delivering cloud-based SaaS solutions and AI-enabled products. You will lead critical technology initiatives in the delivery of its services, solutions, and processes while improving customer and employee satisfaction in a highly regulated healthcare environment.

This is a Remote opportunity 

Program/Project Leadership and Cross-Functional Collaboration:

• Leads projects and working teams to effectively initiate, plan, execute, monitor, and close projects 
• Leads projects through issues, roadblocks, and problems 
• Acts as a change agent to drive teams toward success 
• Owns the projects, timeline, budget, resource constraints, and deliverables / results 
• Shifts between the big picture and the small-but-crucial details 
• Is prepared to roll up their sleeves and work through detailed issues 
• Manages projects to ensure all appropriate tools are completed and used effectively (e.g., charter, Gantt chart, status updates) 
• Performs root cause analysis on project shortfalls and takes corrective action as necessary 
• Applies project management tools and techniques, as well as other QMS principles and tools, toward a variety of large, and inter-related, projects 
• Establishes and leads programs comprised of multiple projects, including designing how information is rolled up and cascaded down, operating rhythms and mechanisms, and tracking against the integrated set of milestones and deliverables 
• Lead the end-to-end delivery of Quest products or cloud-based solutions, from conception to launch, with a focus on operationalizing and scaling the product. Manage milestones, timelines, and cross-functional coordination to meet performance, reliability, and security standards.
• Drive execution of architecture, security, AI, Data Review Board requirement activities and documentation of API management.

Technical Leadership and Cross-Functional Collaboration:

• Manage and align multiple cross-functional teams, including engineering, product, Operations, Quality/Regulatory Affairs, Compliance, marketing, security, and legal, to achieve product and business goals.
• Communicate complex technical concepts effectively to non-technical stakeholders and senior leadership, ensuring alignment on deliverables and driving accountability.
• Proactively identify resource needs, manage risks, and implement mitigation plans to adapt strategies and address challenges throughout the program lifecycle.
• Guides team members to perform through issues and constraints.
• Actively communicates with project sponsors and stakeholders.
• Deliver scalable, high-performance solutions with minimal downtime, optimizing infrastructure and algorithms for efficiency.
• Leverage Agile methodologies to manage sprint planning, backlog grooming, and retrospectives, ensuring timelines and technical debt are effectively managed while maintaining quality and iterative development efficiency
• Collaborate with engineering teams to ensure robust security and compliance in cloud deployments, addressing concerns such as data protection, encryption, identity management, and adherence to standards like GDPR and SOC 2.
• Metrics, Monitoring, and Performance Optimization:
• Define and track key performance indicators (KPIs) for Quest systems, including AI model accuracy, latency, scalability, user engagement, uptime, retention, and supplier performance.
• Use data-driven insights and post-launch feedback to continuously refine user experience, product features, automated processes, and AI components, driving iterative improvements and optimizing performance.
• Other duties as required.

Required Work Experience:

• Demonstrated experience leading large or complex projects with multiple workstreams from initiation to completion (8-10 years experiences) in a GxP environment in the Pharmaceutical, Medical Device or Biotech Industry.
• Minimum 5 years’ experience leading cloud-based product cross-functional teams including infrastructure, scalability, deployment, and security, with a focus on program-level delivery and coordination.
• Experience working within the medical device or healthcare technology sector, with a thorough understanding of regulatory requirements
• Ability to balance tactical execution with aligning short-term program goals to long-term strategic objectives
• Knowledge of SaaS business models.
• Understanding of the critical security concerns in cloud deployments, such as data protection, encryption, identity management, and compliance (e.g., GDPR, SOC 2), and work cross-functionally to implement these standards.
• Experience in managing the cloud infrastructure needed to support SaaS products, including scalability, cost management, and ensuring service availability. 
• The Technical Program Manager should be able to manage large, distributed cloud environments and work with engineers to optimize cloud resource usage and performance.
• Expert with MS: Suite including Power Point, Excel, and Word
• Current Project Management Professional (PMP) certification
• Strong experience with Agile methodologies to manage programs effectively, including managing sprint planning, backlog grooming, and sprint retrospectives while ensuring that timelines and technical debt are managed properly.
• Exceptional communication skills, with the ability to convey updates effectively and manage stakeholder expectations.

Preferred Work Experience: 

• Experience working within the medical device or healthcare technology sector, with a thorough understanding of regulatory requirements
• Ability to balance tactical execution with aligning short-term program goals to long-term strategic objectives
• Experience in client-facing role such as consulting, project management, or process improvement (Six Sigma/ LEAN) while serving as advocate for client’s needs

Physical and Mental Requirements:

• Capability to move around the lab space and various environments including warehouse, laboratory, office.
• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skits to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Effective communication skills to collaborate with various teams and present finding effectively.

Knowledge:

• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Working knowledge of both FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, FDA requirements
• Demonstrated knowledge of business impact of compliance issues and risk management.
• General knowledge of Hoshin and breakthrough planning

Skills:

• Experience in client-facing role such as consulting, project management, or process improvement (Six Sigma/ LEAN) while serving as advocate for client’s needs 
• Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Enterprise Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
• Ability and willingness to roll up sleeves and engage in resolving day-to-day issues.

EDUCATION

Bachelors Degree Required 

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets