Sotera Health Company
Reporting to the VP Global QA, the Director of Quality Assurance provides technical, compliance, and regulatory guidance to processing facilities has responsibility for the quality oversight of Sterigenics’ quality system implementation and execution.
Duties and Responsibilities
Ensure compliance with global regulatory bodies, including but not limited to FDA, ISO, MHLW/JPAL, USDA and MHRA.
Track and understand all applicable Quality regulations that impact Sterigenics operations.
Work with local regulatory agencies on new and existing permits, licenses and regulations that impact our operations.
Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to the appropriate levels of management.
Support facilities during internal and external audits and in response to internal and external audit findings.
Participate in Management Reviews and monthly data analysis meetings.
Provide technical support regarding the quality management system to senior staff and facility management.
Ensure the consistent application and maintenance of the Quality Management System across the facilities. Participate or lead the development, review, and approval of appropriate levels of the system.
Represent Sterigenics on national standards groups as appropriate.
Ensure active participation by the Quality organization with Operations in establishing best‑demonstrated practices.
Work with customers to resolve problems and achieving productivity gains wherever possible.
Work with Operations, Sales and Engineering to justify and implement capital projects and engineering/process changes as required. The responsibility for a successful project includes meeting applicable regulatory and quality system requirements.
Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner.
Participate in customer meetings presenting Sterigenics quality processes, projects and results.
Participate in the hiring and training of QA staff with the potential to advance into higher positions.
Develop and improve training programs that include job function, as well as interpersonal skills and personal development training.
Provide input for Quality Manager appraisals to the appropriate General Manager or VP of Operations.
Provide input for all disciplinary actions taken on all regional QA employees.
Prepare and understand, as required, budgets and financial plans for the Quality organization. Meet budget responsibilities in QA operating plan.
Work with Operations to meet or exceed the fiscal goals of the organization.
Supervision Given
Directly Supervised by the Global VP Of Quality Assurance.Indirectly reports to the Regional VP of Operations.
The Director of Quality Assurance has indirect responsibility for the QA Managers within the region.
Education, Experience, and Skills Required
Bachelor’s Degree or 8 years of experience in quality / sterilization (or related field).
Relevant experience in management function (minimum 3 years).
Proficiency in the pharmaceutical / medical device industry is preferred.
Proficiency in auditing and being audited.
Proficiency in CAPA performance.
Experience with Quality Systems and applying Regulatory Standards.
Experience with ISO and FDA regulations.
Must be able to read, write and speak English.
Excellent organizational skills.
Excellent communication skills on all levels.
Efficient, accurate, works according to plan.
Flexible.
Problem-solving attitude.
High profile commitment to quality.
Special Requirements
Requires travel up to 30%.
Some international travel is expected.
Training Required
Must complete all required training for a “Quality Assurance Director” outlined in the training program.
Pay & Benefits Salary Range: $127,000 - $216,000 per year; depending on experience.
Sotera Health offers a competitive benefits package that includes:
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
401(k) program with Company match that immediately vests
Paid holidays, vacation and sick time
Free financial planning assistance
Paid parental leave
Education assistance
Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
Employee Assistance Program (EAP)
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
VEVRAA Federal Contractor
#J-18808-Ljbffr
Duties and Responsibilities
Ensure compliance with global regulatory bodies, including but not limited to FDA, ISO, MHLW/JPAL, USDA and MHRA.
Track and understand all applicable Quality regulations that impact Sterigenics operations.
Work with local regulatory agencies on new and existing permits, licenses and regulations that impact our operations.
Lead programs to ensure continuous operational quality improvement as measured by quality metrics and reported to the appropriate levels of management.
Support facilities during internal and external audits and in response to internal and external audit findings.
Participate in Management Reviews and monthly data analysis meetings.
Provide technical support regarding the quality management system to senior staff and facility management.
Ensure the consistent application and maintenance of the Quality Management System across the facilities. Participate or lead the development, review, and approval of appropriate levels of the system.
Represent Sterigenics on national standards groups as appropriate.
Ensure active participation by the Quality organization with Operations in establishing best‑demonstrated practices.
Work with customers to resolve problems and achieving productivity gains wherever possible.
Work with Operations, Sales and Engineering to justify and implement capital projects and engineering/process changes as required. The responsibility for a successful project includes meeting applicable regulatory and quality system requirements.
Work with the applicable sales representatives to support the customers’ needs and to resolve issues in a timely manner.
Participate in customer meetings presenting Sterigenics quality processes, projects and results.
Participate in the hiring and training of QA staff with the potential to advance into higher positions.
Develop and improve training programs that include job function, as well as interpersonal skills and personal development training.
Provide input for Quality Manager appraisals to the appropriate General Manager or VP of Operations.
Provide input for all disciplinary actions taken on all regional QA employees.
Prepare and understand, as required, budgets and financial plans for the Quality organization. Meet budget responsibilities in QA operating plan.
Work with Operations to meet or exceed the fiscal goals of the organization.
Supervision Given
Directly Supervised by the Global VP Of Quality Assurance.Indirectly reports to the Regional VP of Operations.
The Director of Quality Assurance has indirect responsibility for the QA Managers within the region.
Education, Experience, and Skills Required
Bachelor’s Degree or 8 years of experience in quality / sterilization (or related field).
Relevant experience in management function (minimum 3 years).
Proficiency in the pharmaceutical / medical device industry is preferred.
Proficiency in auditing and being audited.
Proficiency in CAPA performance.
Experience with Quality Systems and applying Regulatory Standards.
Experience with ISO and FDA regulations.
Must be able to read, write and speak English.
Excellent organizational skills.
Excellent communication skills on all levels.
Efficient, accurate, works according to plan.
Flexible.
Problem-solving attitude.
High profile commitment to quality.
Special Requirements
Requires travel up to 30%.
Some international travel is expected.
Training Required
Must complete all required training for a “Quality Assurance Director” outlined in the training program.
Pay & Benefits Salary Range: $127,000 - $216,000 per year; depending on experience.
Sotera Health offers a competitive benefits package that includes:
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
401(k) program with Company match that immediately vests
Paid holidays, vacation and sick time
Free financial planning assistance
Paid parental leave
Education assistance
Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
Employee Assistance Program (EAP)
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
VEVRAA Federal Contractor
#J-18808-Ljbffr