VP Engineering & Production Quality

ABOUT THIS JOB

Location:

Virginia Beach, VA

Department:
Production & Logistics

Clinical Status:
Non Clinical

The Vice President (VP), Engineering and Production Quality is a key senior leader responsible for shaping and executing engineering and technical strategy for human tissue processing, medical device manufacturing, and cellular therapy product platforms. This role oversees product and process engineering, production quality, internal operation quality objectives, project management, technology transfer, continuous improvement/cost initiatives, and equipment reliability.

The VP ensures all engineering and production activities meet defined quality standards, support robust in-process controls, and maintain a state of compliance throughout the manufacturing lifecycle. The VP ensures the organization maintains operational excellence, technical rigor, regulatory compliance, and innovation to support the company’s growth objectives. Additionally, the VP brings deep experience leading engineering in a highly regulated environment (e.g., HCT/Ps, biologics, medical devices, or advanced therapies) and thrives in a fast-paced, mission-driven organization focused on product quality and patient impact.

Your work will have purpose every single day, contributing directly to life-changing outcomes.

• Engineering Leadership & Strategy
  :
  Develops and executes the multi-year engineering strategy supporting growth, capacity expansion, automation, and modernization across all product lines. Provides senior leadership to engineering, process development, maintenance, capital projects, validation, and facilities teams. Partners with executive leadership to align engineering priorities with corporate strategy, operational goals, and regulatory expectations.
• Technical Operations & Execution
  :
  Leads engineering activities for human tissue processing, medical device manufacturing, and cellular therapy operational platforms, ensuring robust process performance, scalability, and compliance. Oversees execution of major capital projects, including facility expansions, cleanroom upgrades, aseptic processing enhancements, and new technology installations. Ensures equipment reliability programs meet uptime, utilization, and performance metrics. Drives continuous improvement initiatives leveraging Lean, Six Sigma, and advanced manufacturing principles.
• Regulatory & Quality Compliance
  :
  Ensures all engineering programs, processes, and equipment meet applicable regulatory and industry standards (FDA 21 CFR 1271, 820, 210/211, AATB, ISO 13485, cGMPs for ATMPs, etc.). Oversees validation, qualification, and change control activities in alignment with Quality systems. Partners closely with Quality and Regulatory Affairs to prepare for inspections, submissions, and external audits.
• Innovation & Product Support
  :
  Champions engineering innovation to enhance product quality, safety, and manufacturability across biological tissues, medical devices, and cell therapy products.
• Supports R&D and Process Development
  :
  Supports technology transfer, scale-up, and commercialization of new products and processes. Introduces digital technologies, automation, and data-driven tools to optimize operations and improve process robustness.
• Operational Leadership
  :
  Builds and develops a high-performing engineering organization with strong technical depth and leadership capability. Strengthens cross-functional collaboration with Operations, Quality, Supply Chain, R&D, and Program Management. Develops and manages departmental budgets, ensuring resource optimization and effective cost control.

Minimum Requirements:

• Bachelor’s Degree in Engineering (Mechanical, Biomedical, Chemical, Electrical, or related discipline)
• Fifteen (15) years experience in Operations/ Production/ Manufacturing in Life Sciences, Tissue Banking, Medical Device, Pharmaceuticals, or related industry (Preferred 20 years)
• Twelve (12) years’ experience of managing direct reports (Preferred 15 years)

Key Knowledge, Skills, & Abilities:

• Computer Skills
  :
  Proficient with engineering and operations systems and data analytics tools; ability to leverage…