Associate Director, Quality & Regulatory Compliance

Linde Gas & Equipment Inc.

Associate Director, Quality & Regulatory Compliance 

Location: Bethlehem, PA

Linde Gas & Equipment Inc. is seeking a Associate Director, Quality & Regulatory Compliance to join our team! Associate Director, Quality & Regulatory Compliance is accountable for the implementation and maintenance of comprehensive quality and compliance programs governing medical gases and pharmaceutical gases. This role ensures adherence to cGMP, FDA, ISO, and international regulatory standards, while supporting core functions such as manufacturing, clinical affairs, and commercial operations.

What we offer you!

·         Competitive compensation

·         Comprehensive benefits plan (medical, dental, vision and more)

·         401(k) retirement savings plan

·         Paid time off (vacation, holidays, PTO)

·         Employee discount programs

·         Career growth opportunities

·         Additional compensation may vary depending on the position and organizational level

What you will be doing:

• Lead quality oversight for cGMP-compliant manufacturing operations at the Bethlehem, PA; Alpha, NJ, facilities with focus on product integrity and patient safety. 

• Oversee triage, investigation, and reporting of adverse events and product complaints in accordance with pharmacovigilance and medical gas/pharmaceutical vigilance protocols. 

• Develop and sustain systems for federal and state regulatory reporting obligations (e.g., Sunshine Act, CARES Act) to ensure full transparency and compliance. 

• Ensure each site maintains appropriate Quality staffing, training, and competency levels to support rigorous product quality and safety standards. 

• Drive harmonization of quality procedures, QMS documentation, and compliance practices across global manufacturing and distribution facilities. 

• Collaborate with functional stakeholders to guide product lifecycle management initiatives, incorporating risk-based quality strategies and continuous improvement methodologies. 

• Provide regulatory and quality guidance to cross-functional product development teams, aligning innovation with safety, efficacy, and compliance standards. 

• Participate in vendor qualification and oversight, ensuring alignment with GxP and ISO expectations for suppliers of components and services.

What makes you great:

• Bachelor’s degr