R10049594 Director of Quality and Food/Pharma Compliance (Open)

Location:

Salt Lake City, UT (ASU-AMG) - ASU

How will you CONTRIBUTE and GROW?

We are hiring!

Airgas is hiring for a Director of Quality and Food/Pharma Compliance

At Airgas, we RESPECT, HONOR and VALUE diversity. We are invested in cultivating a dynamic and inclusive culture.

• Remote Role; Up to 70% travel

• Strong passion for fostering an environment of Diversity, Inclusion and Respect.

• Experience with developing, contributing, and supporting Airgas' commitment to a World Class Service, exceeding customer expectations and building brand loyalty.

Excellent Benefits: Airgas offers a full benefits package that includes: Medical, Dental, Vision, Life, AD&D, Short Term and Long Term Disability Insurance, Vacation, Sick, Paid Holidays, 401(k) Retirement Plan with company match, and Tuition Assistance. Additionally, we have a Scholarship Program for Dependent Children, Parental Leave of up to 2 weeks of paid parental leave to eligible associates, and Child Birth Benefit for eligible associates (birth mothers) of 14 weeks of leave at 100% pay. Benefits start after 30 days of employment.

Recruiter: Quentin Chavis Jr / [email protected] / 346-459-4397

Job Description Summary: The Director of Quality & Food/Pharma Compliance position provides regional quality and compliance leadership in support of Airgas Merchant Gases (AMG) operations, logistics and sales. This position assures compliance to all statutory and regulatory requirements and that products produced are safe while meeting both Airgas and customer quality specifications. In addition, the Director of Quality & Food/Pharma Compliance drives continual improvement by challenging current practices and identifies improvements that enhance efficiency and eliminate waste.

• Assure AMG and Joint Venture (e.g. FRVE) programs are compliant with current FDA food and drug regulations and all other state, federal, and international statutory and regulatory requirements.

• Interpret and advise leadership of the applicability of U.S. federal, state, and international regulations and customer driven requirements.

• Leads the development and implementation of annual improvement strategies to strengthen quality and compliance programs within the assigned area. 

• Monitors government regulations, professional, trade publications and advises the Senior Director of new and changing food and drug regulations, customer requirements and/or industry litigation.

• Represents AMG when meeting with federal and state regulatory agencies regarding food & drug registrations, licenses, permits, enforcement actions and public hearings as required.

•  Assures that zone facility Federal and State food and drug manufacturing and distribution licenses and permits are current.

• Provides regulatory and internal QMS leadership when supporting AMG operations, distribution, and sales teams to achieve growth objectives and strategies.

• Leads investigations and root cause analysis to assure effective corrective and preventive actions to customer complaints or product quality nonconformities. 

• Leads field staff and provides advisory support for FDA government inspections, customer and certification audits. 

• Directs the drafting of audit responses to certification and customer audits. Works with Airgas SAFECOR when responding to audit findings resulting from FDA inspections.  

• Develop and lead annual internal compliance audit plans in accordance with cGMP and AMG requirements. 

• Leads assigned projects and assures manufacturing and product delivery processes used for the manufacture, storage and delivery of drug products are properly validated in accordance with FDA and CGA requirements.

• Reviews corrective actions and leads efforts to “fan out” resolutions to all affected sites to prevent repeat events.

• Leads Quality and Compliance field awareness through the sharing of performance metrics and relevant audit data.

• Utilizes cost benefit analysis and risk based methodologies when drafting quality and compliance program improvements to confirm value prior to commitment. 

• Lead site qualification for ABO and other products used for military applications.

• Provides QMS leadership by verifying that field staff is adequately trained to perform all required duties and to remain current on new regulations and quality trends.

• Supports IMS Implementation, as needed, in areas of procedure revision, auditing, and gap closure plans creation.

• Provides leadership for third party (Coke, Pepsi, Tyson Foods etc.) audits, qualifications to ensure completion per customer expectations. 

• Leads efforts to  attain facility FSSC 2000, ISO 9001, NSF 60, Kosher, Halal, and Non-GMO certifications.

• Lead Auditor for internal audit program.

• Leads food safety HACCP, HARPC and quality risk assessments.

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Are you a MATCH?

Required Qualifications

• Bachelor’s degree in Engineering or Natural Science OR combination of education and equivalent work experience in Quality or Compliance Management

• At least five years quality management experience with supervision of staff required

• Working knowledge of Google Chrome (Docs, Sheets, Slides, Drive and Gmail)

• Experience with drug manufacturing and distribution regulations, cGMP, food safety management, HACCP/HARPC, process validation, FMEA, root cause analysis and quality management systems and related software.

• Understanding of USFDA, Health Canada, European, and/or other international regulations and standards.

Preferred Qualifications

• Master’s Degree is a plus. 

• 8 to 10 years of quality management experience preferred

• Previous experience in the industrial, electronic, and/or specialty gas business preferred.

• Working knowledge of Lean Six Sigma is beneficial. 

• Certified Lead Auditor for ISO 9001, 13485, 17025, or FSSC 22000 a plus

• CQA, QE, CQT, CMQ/OE, CSSBB beneficial.

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Your differences enhance our performance

At Airgas, we are committed to building a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.

We welcome and consider applications from all qualified applicants, regardless of their race, gender, sexual orientation, religion, disability or any other protected characteristic. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.

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Equal Employment Opportunity Information
 

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. 

Please click here to view the EEO Know Your Rights poster and here to view the Pay Transparency Nondiscrimination poster. Airgas, an Air Liquide Company invites any applicant and/or employee to review the Company’s written Affirmative Action Plan or Policy Statement. This plan or policy statement is available for inspection upon request.

Airgas, an Air Liquide Company and its group of companies does not discriminate against qualified applicants with disabilities and is committed to providing reasonable accommodations to the known disabilities of such individuals so as to ensure equal access to benefits and privileges of employment. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact us by email at [email protected].

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