Senior Director, Device Quality & Regulatory Excellence

AstraZeneca; Gaithersburg (MD); On-site; USD 175,000 - 262,000; Full time

Benefits offered by this job

Retirement plans

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca in Gaithersburg, MD seeks a Senior Quality Leader to oversee the quality systems for commercial combination products and devices. You will drive design transfer, process validation, and regulatory compliance while building a high-performing team.

You will partner with stakeholders to set strategic imperatives, advance post-market data guidance, and ensure global standards (21 CFR, ISO 13485) are consistently applied. This role demands extensive experience and proven leadership.

Qualifications

• BS or MS in engineering or equivalent field.
• 15+ years of experience in quality engineering for combination products and devices.
• Extensive knowledge of global QMS requirements (21 CFR Parts 4, 210, 211, 803, 806, 820; ISO 13485).
• Extensive knowledge of US and international Design Control and Risk Management (21 CFR 820.30, ISO 13485, ISO 14971, MDD 93/42/EEC).
• Proven leadership in building and growing a team.

Responsibilities

• Senior level leadership of quality oversight for commercial combination products and devices.
• Oversee design transfer, process validation.
• Build a team environment embodying AZ core values and fostering growth.
• Partner with key stakeholders to align on strategic imperatives and approaches.
• Lead medical device and combination product quality system initiatives.
• Develop strategies for no-market support.
• Ensure compliance with global regulations in manufacturing.
• Provide guidance for post-market data and improvements.
• Senior guidance on design controls for post-market activities.

Skills

Quality leadership

Quality engineering

Design controls

Regulatory compliance

Stakeholder collaboration

Team building

Education

Engineering degree

Job description

AstraZeneca in Gaithersburg, MD seeks a Senior Quality Leader to oversee the quality systems for commercial combination products and devices. You will drive design transfer, process validation, and regulatory compliance while building a high-performing team.

You will partner with stakeholders to set strategic imperatives, advance post-market data guidance, and ensure global standards (21 CFR, ISO 13485) are consistently applied. This role demands extensive experience and proven leadership.