Associate Director, Quality & Regulatory Compliance

What makes you great:

• Bachelors degree in a scientific engineering or health sciences discipline.

• Minimum of 5 years of quality and/or regulatory experience within the pharmaceutical or medical device sectors.

• Demonstrated expertise in FDA Quality System Regulations (21 CFR Part 820) 21 CFRISO 9001 and global regulatory frameworks for drugs and devices.

• Proven experience with audits inspections complaint handling and CAPA systems.

• Exceptional communication skills with the ability to translate technical and regulatory concepts into clear actionable guidance.

• Adept at leading quality teams managing change and fostering a culture of compliance and operational excellence.

• Proficient in Microsoft Office suite; knowledge of quality management systems and electronic documentation tools preferred.

• Must reside in or be willing to relocate to Bethlehem PA.

• Travel requirement: 30%.

Why you will enjoy working with us:

Linde is a leading global industrial gases and engineering company with 2024 sales of $33 billion. We live our mission of making our world more productive every day by providing high-quality solutions technologies and services which are making our customers more successful and helping to sustain decarbonize and protect our planet.

Linde Gas & Equipment Inc. (LG&E) is part of the largest Welding Industrial Medical and Specialty Gases companies in the U.S. We carry a comprehensive selection of industrial gases such as oxygen nitrogen argon and carbon dioxide etc. LG&E has an extensive network of production plants retail stores distribution centers and customer service locations with a focus on making our world more productive every day by providing high-quality solutions technologies and services which are making our customers more successful by helping to sustain and protect our planet.

For more information about the company please visit our website.

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All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age disability protected veteran status pregnancy sexual orientation gender identity or expression or any other reason prohibited by applicable law.

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.