Director of Quality and Food/Pharma Compliance - AIRGAS USA, LLC
Cleveland, OH
About the Job
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 / quentin.chavisjr@airgas.com / 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 event
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 / quentin.chavisjr@airgas.com / 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 event
Source : AIRGAS USA, LLC