Senior Director Quality

NIPRO Corporation - Global; Lewisberry (PA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Nipro Medical Corporation in Lewisberry, PA seeks a Senior Director of Quality Assurance to lead all quality functions at the site’s manufacturing facility. You will guide FDA inspections, regulatory audits, and quality-system transformation while partnering with cross-functional teams to drive operational excellence.

As the senior quality leader, you will manage QA, supplier quality, validation, and quality engineering, shaping a culture of compliance, accountability, and continuous improvement

Qualifications

• 15+ years of progressive quality leadership in regulated manufacturing.
• 8+ years in senior or director-level quality leadership.
• Experience in medical device, pharma, biotech, or combination products.
• Proven success with FDA inspections, audits, and remediation programs.
• ASQ Certified Quality Auditor (CQA) preferred.
• Strong knowledge of QMS, FDA regs, and global quality standards.
• Experience with ISO 13485 & MDSAP, CAPA, and root cause analysis.
• FDA 21 CFR 820 familiarity and inspection readiness.

Responsabilités

• Lead the site quality strategy aligned with corporate objectives.
• Oversee QA, Quality Systems, Compliance, Supplier Quality, Validation, and QA Engineering.
• Drive a culture of quality, compliance, and continuous improvement.
• Serve as primary site quality representative for FDA inspections and audits.
• Lead quality reviews, regulatory remediation, and 483/Warning Letter responses.
• Develop and mentor a high-performing quality organization.
• Partner with Manufacturing, Engineering, Regulatory, Supply Chain, and Leadership to mitigate risks.
• Manage budgets, resources, and performance metrics for strategic quality initiatives.

Connaissances

Leadership

Quality leadership

Regulatory compliance

FDA inspections

Cross-functional collaboration

Formation

Bachelor's degree in Engineering, Quality, Life Sciences, Chemistry, Microbiology, Biotechnology, Pharmacy

Description du poste

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