Manager, Quality Assurance - Cardinal Health
Honolulu, HI
About the Job
_What Quality Assurance contributes to Cardinal Health_
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
_Job Summary_
The Manager Quality Assurance analyzes and investigates adverse drug reactions, reviews complaints for drug complaint issues, provides clinical support to field operations, and sets safety policy procedures and creation. The job will be responsible for scanning general complaint inboxes for applicable drug reaction complaints. The job maintains standards and responsiveness compliant with regulations and written contracts with suppliers.
_Responsibilities_
+ Reviews drug reaction complaints from physicians/patients and investigates accordingly.
+ Collates drug complaint data and conducts analysis for internal and external stakeholders.
+ Serves as a subject matter expert for field operation teams to resolve issues regarding dosing and drug use cases.
+ Escalates Q&A issues with drug manufacturers.
+ Sets safety policy procedures and defines policies for safety preparation, appropriate escalation, and drafting letters to customers.
+ Trains junior staff and performs other ad hoc requests.
+ Position is also responsible for Quality Compliance across the PET Network
+ Will assist PET locations with FDA readiness checks
+ Supports and manages FDA inspections and any responses
+ Supports Corporate audits and corporate audit responses
+ Assists with Annual Product Reviews
_Qualifications_
+ 8-12 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
_What is expected of you and others at this level_
+ Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
+ Participates in the development of policies and procedures to achieve specific goals
+ Recommends new practices, processes, metrics, or models
+ Works on or may lead complex projects of large scope
+ Projects may have significant and long-term impact
+ Provides solutions which may set precedent
+ Independently determines method for completion of new projects
+ Receives guidance on overall project objectives
+ Acts as a mentor to less experienced colleagues
Anticipated salary range: $102,000 - $145,700
Bonus eligible: Yes/No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
Application window anticipated to close: 5/31/2024 *if interested in opportunity, please submit application as soon as possible.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
_Job Summary_
The Manager Quality Assurance analyzes and investigates adverse drug reactions, reviews complaints for drug complaint issues, provides clinical support to field operations, and sets safety policy procedures and creation. The job will be responsible for scanning general complaint inboxes for applicable drug reaction complaints. The job maintains standards and responsiveness compliant with regulations and written contracts with suppliers.
_Responsibilities_
+ Reviews drug reaction complaints from physicians/patients and investigates accordingly.
+ Collates drug complaint data and conducts analysis for internal and external stakeholders.
+ Serves as a subject matter expert for field operation teams to resolve issues regarding dosing and drug use cases.
+ Escalates Q&A issues with drug manufacturers.
+ Sets safety policy procedures and defines policies for safety preparation, appropriate escalation, and drafting letters to customers.
+ Trains junior staff and performs other ad hoc requests.
+ Position is also responsible for Quality Compliance across the PET Network
+ Will assist PET locations with FDA readiness checks
+ Supports and manages FDA inspections and any responses
+ Supports Corporate audits and corporate audit responses
+ Assists with Annual Product Reviews
_Qualifications_
+ 8-12 years of experience, preferred
+ Bachelor's degree in related field, or equivalent work experience, preferred
_What is expected of you and others at this level_
+ Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
+ Participates in the development of policies and procedures to achieve specific goals
+ Recommends new practices, processes, metrics, or models
+ Works on or may lead complex projects of large scope
+ Projects may have significant and long-term impact
+ Provides solutions which may set precedent
+ Independently determines method for completion of new projects
+ Receives guidance on overall project objectives
+ Acts as a mentor to less experienced colleagues
Anticipated salary range: $102,000 - $145,700
Bonus eligible: Yes/No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
Application window anticipated to close: 5/31/2024 *if interested in opportunity, please submit application as soon as possible.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Source : Cardinal Health