Senior Manager Quality & Compliance

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

• Bachelor’s degree in a scientific discipline is required, or equivalent related experience.
• An advanced degree is preferred.

• Extensive knowledge of pharmaceutical, medical device, and/or cosmetic Quality Management Systems.
• Expert knowledge of FDA regulations, 21 CFR Parts 210, 211, 820, ISO, Health Canada, ICH guidelines, GDP, and Data Integrity requirements.
• Extensive understanding of Quality Risk Management, regulatory inspection management, audit practices, and compliance frameworks.
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies.

• 10+ years of progressive Quality Assurance, Quality Systems, and Compliance experience within a life sciences technology driven organization.
• 10+ years of leadership experience managing Quality Systems, Compliance, or Quality Assurance teams.
• Experienced ownership of site-wide Quality Management Systems.
• Proven experience leading regulatory inspections and managing interactions with FDA, Health Canada, and other regulatory agencies.
• Significant experience managing audits, CAPA systems, risk management processes, and compliance remediation programs.
• ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CMQ/OE), Six Sigma Green Belt or Black Belt preferred.

• Strategic leadership with the ability to influence all levels of the organization.
• Strong business acumen and ability to balance compliance requirements with operational objectives.
• Exceptional proactive problem-solving, risk assessment, and decision-making capabilities.
• Strong project and change management skills.
• Excellent verbal, written, presentation, and executive communication skills.
• Proven ability to lead cross-functional teams and drive organizational change.
• Highly collaborative with strong stakeholder management capabilities.
• Ability to successfully manage multiple priorities in a dynamic, fast-paced regulated environment.
• Results-oriented with a strong commitment to quality, compliance, patient safety, and continuous improvement.

• No hazardous or significantly unpleasant conditions.
• Primarily office-based with occasional travel to manufacturing or laboratory facilities for audits and inspections.
• Some physical activity required during site visits, including walking and standing for extended periods.
• Ability to lift and carry equipment or materials as needed.

• $160,000 - $180,000 annually, plus bonus