Description

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 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 CFR 213, 210, 211, ISO 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. Don't wait, fill out an application right from your phone today! DRIVE YOUR CAREER FORWARD! 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.