Regulated Life Sciences Program Manager

Top Stack; Frazer Township (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Top Stack is seeking an experienced Program Manager to lead cross-functional product development and lifecycle initiatives within a highly regulated environment. You will guide programs from concept through launch, coordinating across engineering, operations, quality, regulatory, marketing and customer-facing teams.

The role requires strong planning, risk management, and communication skills, with a track record in hardware and software development and adherence to FDA QSR, GMP, and ISO

Qualifications

• Minimum 5+ years in regulated industry such as life sciences, pharmaceutical, aerospace, or defense.
• Experience managing product development or lifecycle programs.
• Knowledge of new product development and lifecycle processes.
• Understanding of FDA QSR, GMP, and ISO standards.
• Experience with hardware and software development.

Responsibilities

• Lead cross-functional product development and lifecycle projects from concept through launch.
• Develop and manage project plans, schedules, budgets, milestones, and deliverables.
• Coordinate across engineering, operations, quality, regulatory, marketing, and customer-facing teams.
• Identify project risks, resolve issues, and keep projects on schedule and within budget.
• Oversee hardware and software development, testing, validation, manufacturing readiness, and product launches.
• Ensure projects meet applicable quality and regulatory requirements.
• Provide project status updates and communicate progress to leadership.

Skills

Cross-functional leadership

Project management

Regulated industry experience

Stakeholder communication

Six Sigma

Job description

Top Stack is seeking an experienced Program Manager to lead cross-functional product development and lifecycle initiatives within a highly regulated environment. You will guide programs from concept through launch, coordinating across engineering, operations, quality, regulatory, marketing and customer-facing teams.

The role requires strong planning, risk management, and communication skills, with a track record in hardware and software development and adherence to FDA QSR, GMP, and ISO