Senior Director Quality

Nipro Medical Corporation is seeking an experienced and strategic Senior Director of Quality Assurance to lead all quality functions at our Lewisberry, Pennsylvania manufacturing facility. This executive leadership role will serve as the site's senior quality leader, ensuring compliance with FDA regulations, global quality standards, and quality management system requirements while supporting operational excellence across manufacturing, distribution, supplier quality, and post-market activities.

The ideal candidate brings extensive leadership experience within a regulated medical device, pharmaceutical, biotechnology, or combination-product manufacturing environment, with a proven track record of guiding organizations through FDA inspections, regulatory audits, compliance remediation, and quality system transformation.

Key Responsibilities

• Lead and execute the site quality strategy in alignment with corporate objectives and business goals.
• Provide oversight for Quality Assurance, Quality Systems, Compliance, Supplier Quality, Validation, and Quality Engineering.
• Drive a culture of quality, compliance, accountability, and continuous improvement.
• Serve as the site's primary quality representative for FDA inspections, regulatory audits, and third-party assessments.
• Lead quality management reviews, compliance initiatives, and regulatory remediation efforts, including FDA Form 483 and Warning Letter responses.
• Develop and mentor a high-performing quality organization through effective leadership, coaching, succession planning, and talent development.
• Partner cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, Operations, and Executive Leadership to identify and mitigate quality risks.
• Manage departmental budgets, resources, performance metrics, and strategic quality initiatives.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Chemistry, Microbiology, Biotechnology, Pharmacy, or a related technical discipline.
• ASQ Certified Quality Auditor (CQA) preferred.
• 15+ years of progressive quality leadership experience in regulated manufacturing environments.
• 8+ years of experience in senior management or director-level quality leadership positions.
• Experience in medical device, pharmaceutical, biotechnology, and/or combination-product manufacturing.
• Demonstrated success leading FDA inspections, regulatory audits, and compliance remediation programs.
• Strong experience with Quality Management Systems (QMS), FDA regulations, and global quality standards.

Expertise Desired

• FDA QSR / 21 CFR Part 820
• GMP Regulations
• FDA Inspection Readiness
• ISO 13485 & MDSAP
• Risk Management (ISO 14971)
• CAPA & Root Cause Investigations
• Validation Programs
• Supplier Quality Systems
• Quality Metrics & Analytics
• Statistical Analysis & Risk-Based Decision Making