Quality Manager | Pharmaceutical & Life Sciences Packaging

The International Society for Pharmaceutical Engineering, Inc.; Monroe (OH); Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

401(k) match

Comprehensive benefits

Hybrid work schedule

Job summary

The International Society for Pharmaceutical Engineering, Inc. is seeking a Quality Manager to own ISO 9001 and ISO 14001 for a core parcel packaging product line at a global manufacturer serving the pharma and life sciences industry.

This hands-on leadership role manages a small quality team, leads audits, oversees supplier and manufacturing quality, and resolves customer quality concerns from initial inquiry through resolution.

Qualifications

• Ownership of ISO 9001 and ISO 14001 quality systems.
• 5–7+ years of formal people leadership experience.
• Experience leading internal and external quality audits.
• Direct customer-facing quality issue resolution experience.
• Background in packaging, life sciences manufacturing, medical products, pharmaceutical manufacturing, or consumer products manufacturing environments.
• ISO 13485 and/or FDA regulated environment experience is a plus, but not required.

Responsibilities

• Own quality for a core product line within a growing global organization.
• Lead and develop a small quality team.
• Oversee supplier and manufacturing quality performance.
• Manage customer quality concerns from inquiry through resolution.
• Support new product initiatives across the business.

Skills

People leadership

Auditing

Customer resolution

ISO 9001

ISO 14001

Job description

Quality Manager | ISO 9001 & ISO 14001 | Director Track

Global manufacturer of temperature-controlled packaging solutions for the pharmaceutical and life sciences industry is seeking a Quality Manager to own quality for one of its core parcel packaging product lines.

This is a hands-on leadership role managing a small quality team, leading internal and external quality audits, overseeing supplier and manufacturing quality performance, and managing customer quality concerns from initial inquiry through resolution. This position is centered around ownership of the ISO 9001 and ISO 14001 quality management systems and is a true manufacturing quality leadership role, not a purely regulatory or compliance-focused position. The Quality Manager will also play an active role in several new product initiatives being launched across the business.

Key Requirements:

• Demonstrated ownership of both ISO 9001 and ISO 14001 quality management systems
• 5-7+ years of formal people leadership experience with both strategic and tactical responsibilities
• Experience leading internal and/or external quality audits
• Direct customer-facing quality issue resolution experience
• Background within packaging, light manufacturing, life sciences manufacturing, medical products, pharmaceutical manufacturing, or consumer products manufacturing environments
• ISO 13485 and/or FDA regulated environment experience is a plus, but not required

Why This Opportunity:

• Lead quality for a core product line within a growing global organization serving the pharmaceutical and life sciences industry
• Clear path to Director-level leadership with the opportunity to expand scope and influence
• Highly visible role with ownership of quality systems, supplier quality, manufacturing quality, and customer quality initiatives
• Competitive compensation package including 401(k) match, comprehensive benefits, and a hybrid work schedule (4 days onsite, 1 day remote)