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Veterans Preferred - Validation Compliance Manager - Houston Texas
Company: US11345-AIRGAS Airgas USA, LLC
Location: Houston, Texas
Posted On: 04/17/2024
Military Veterans are Encouraged to Apply. -R10040446 Validation Compliance Manager (Open)
Location:
Houston, TX - WLY - Cust. installations
How will you CONTRIBUTE and GROW?
We are HIRING!!
Airgas is Hiring for a REMOTE Validation Compliance Manager!
At Airgas, we RESPECT, HONOR and VALUE diversity. We are invested in cultivating a dynamic and inclusive culture.
We are looking for you!
- Location: Fully remote
- Reports to: Senior Director of Quality & Food Safety
- Travel: 30-50%
- 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, 14 weeks paid child birth benefit, 401(k) Retirement Plan with company match, Tuition Assistance and much more! Benefits Start after 30 days of employment.
Recruiter: Laura Brewer / laura.brewer@airgas.com / 832-954-4791
How will you CONTRIBUTE and GROW?
Job Description Summary: The Validation and Compliance Manager position supports Airgas Merchant Gases (AMG) by leading the validation and qualification of medical product manufacturing and fill systems, analytical equipment and associated software as required by FDA drug manufacturer regulations. The manager assures systems are compliant with Food Safety System Certification (FSSC) 22000; FDA & applicable international regulations, & company standards for system integration, maintenance, and continual improvement.
- Manages Department Validation project initiatives; third party contracted validation services and consultants as applicable. Assign validation tasks and ensure timely completion per established schedules.
- Develop validation test protocols to maintain medical compliance and for special projects.
- Review and approve validation reports from internal & third party execution regarding; qualification policies, procedures, protocols and consultant qualifications.
- Manage the performance of process and analytical validations as assigned by Senior Director Food Safety & Quality Compliance
- Develop, implement and provide guidance on validation strategies, procedures and policies as assigned.
- Research, interpret and apply U.S. and international regulations and standards in relation to the validation of medical product production facilities and analytical instruments in the testing of food, drugs, and medical devices. Develop action plans when required.
- Assist with Regulatory audits at medical and food facilities when required.
- Develop validation and qualification training programs when required.
- Assist the Department with compliance audit report review and investigations concerning validation activities.
- Lead in multi-functional teams to identify analytical best practices, and assist in developing standard validation, qualification and calibration procedures.
- Perform validation assessments of new and existing locations to determine the level of validation required.
- Monitors the facility Management of Change requests to assure that process changes do not adversely affect previous validation.
- Prepare internal communication reports and presentations for validation and quality activities.
- Represents Airgas on industry trade organization task forces directly relating to validation, such as the CGA, as assigned by the manager.
- Assure Airgas Merchant Gases (AMG) Bulk and Onsite Group programs are compliant with current FDA food and drug regulations and all other state, federal, and international statutory and regulatory requirements.
- Support AMG operations, distribution, and sales teams to achieve growth objectives and strategies.
- Supports customer service and product complaints and Root Cause Analysis activities
- Provide corporate and field advisory support for FDA government inspections, customer and certification audits.
- Assists in developing AMG policies and procedures to ensure compliance with regulatory requirements.
- Assure manufacturing and product delivery processes used for the manufacture, storage and delivery of drug products are properly validated in accordance with FDA 21 CFR 210 & 211 and CGA requirements.
- Assure that manufacturing and product delivery processes used for the manufacture, storage and delivery of food products are properly assessed per FSSC 22000 requirements and FDA 21 CFR 117 Food Safety Standards.
- Monitor programs and identify compliance gaps. Initiates actions to close gaps prior to regulatory action.
- Promotes field Quality and Compliance awareness through the sharing performance metrics and relevant audit data.
- Lead quality and compliance training programs for new facilities to ensure that AMG personnel maintain good working knowledge of regulatory requirements.
- Utilize cost benefit analysis and risk based methodologies when drafting quality and compliance program improvements.
- Solicit input from stakeholders to gauge impact of change prior to implementing program revisions.
- Incorporates established root cause analysis methodologies when conducting investigations and identifying effective resolution.
- Promote continual improvement within the group and partners with internal organizations when implementing business improvements.
- Monitors and maintains product quality specifications and advises sales teams of site product capability.
- Assist with qualifying sites for ABO and other products used for military applications.
- Ensure that quality and compliance staff is adequately trained to perform all required duties and to remain current on new regulations and quality trends.
- Provide product quality, analytical and compliance support for product and process related issues
- Facilitate and participate in Site HACCP HARPC & Risk Mitigation Planning
- Is a member of and participates in Quality-related activities of CGA and ISBT
- Supports Customer Advocacy program by provides customer-requested letters of guarantee, certificates of conformance and other product quality assurance correspondence as necessary.
- Serves as TCL analytical expert in support of production group expansion and improvement initiatives.
- Communicates directly with customers in support of product related complaints and supports investigations where analytical expertise is required.
________________________
Are you a MATCH?
Are you a MATCH?
Required Qualifications
- Qualified candidates must possess a Bachelor's degree in Engineering or Natural Science or combination of education and equivalent work experience in Quality Management
- Master's Degree a plus.
- Five (5) to eight (8) years of quality management experience and with supervising a staff required.
- Previous experience in the industrial, Electronic, and/or specialty gas business preferred.
- Strong understanding of analytical validation principles in relation USFDA, Health Canada, European, and other international regulations.
- Strong understanding of HACCP/HARPC Risk management principles and programs
- Understanding of USFDA, Health Canada, European, and other international regulations and standards.
- Five (5) years experience in analytical instruments relating to operation and calibration of instruments for testing drugs or medical devices.
- Five (5) years experience in a medical, biologic, or food regulated environment.
- Eight (8) years experience in managing personnel and/or project teams.
- Working knowledge of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
- Working knowledge of Google applications (Chrome, Docs, Sheets, Slides, Drive and Gmail)
Preferred Qualifications
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