Manager, Quality Assurance - Cardinal Health
Denver, CO
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_
Position will oversee and enhance through continuous improvement the quality systems that support the repackaging of drug products, achieved through collaboration with contract repackagers. The position includes ensuring that the repackaged products meet the highest standards of quality and compliance. Closely monitor and enhance the quality systems in place, to ensure the overall safety and efficacy of the repackaged drug products. Engaging with contract repackagers will be instrumental in streamlining processes and implementing best practices to uphold quality standards throughout the repackaging process.
_Responsibilities_
+ Collaborate with contract repackager’s management team and other business teams to develop systems, validations, and procedures that effectively integrate repackaged products.
+ Responsible for oversight of change control, investigations, complaint investigation, annual product review, retain samples, validation protocols, deviations, non-conformances and CAPAs.
+ Review and approve investigations, validation protocols, deviations, and non-conformances for repackagercompliance with cGMP’s and regulatory requirements.
+ Develop quarterly scorecard, to include on time accountability and quality of expected deliverables/metrics.
+ Position will require approximately 20% travel, to include periodic visits to the repackagers.
_Qualifications_
+ Bachelor’s degree in related field, or equivalent work experience, preferred
+ 8-10 years of experience within the pharmaceutical industry preferred
+ 5+ years of experience as a Manager performing Quality Control in a pharmaceutical manufacturing or packaging environment preferred with an emphasis on solid oral and oral liquid unit dose preferred
+ Effective problem solving and analytical skills able to lead and influence others to drive improvements.
+ Good knowledge in risk assessment and risk management
+ Strong working experience Corrective Action and Preventive Action programs
+ Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Excel and Power Point (statistics, graphing, presentations, etc.)
+ Excellent verbal and written communication skills.
+ Ability to travel 20%
_What is expected of you and others at this level_
+ Manages department operations and supervises professional employees, front line supervisors and/or business support staff
+ Participates in the development of policies and procedures to achieve specific goals
+ Ensures employees operate within guidelines
+ Decisions have a short term impact on work processes, outcomes and customers
+ Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
+ Interactions normally involve resolution of issues related to operations and/or projects
+ Gains consensus from various parties involved
Anticipated salary range: $103,500-$155,292
Bonus eligible: Yes
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: 11/10/2024 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
#LI-Remote
_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_
Position will oversee and enhance through continuous improvement the quality systems that support the repackaging of drug products, achieved through collaboration with contract repackagers. The position includes ensuring that the repackaged products meet the highest standards of quality and compliance. Closely monitor and enhance the quality systems in place, to ensure the overall safety and efficacy of the repackaged drug products. Engaging with contract repackagers will be instrumental in streamlining processes and implementing best practices to uphold quality standards throughout the repackaging process.
_Responsibilities_
+ Collaborate with contract repackager’s management team and other business teams to develop systems, validations, and procedures that effectively integrate repackaged products.
+ Responsible for oversight of change control, investigations, complaint investigation, annual product review, retain samples, validation protocols, deviations, non-conformances and CAPAs.
+ Review and approve investigations, validation protocols, deviations, and non-conformances for repackagercompliance with cGMP’s and regulatory requirements.
+ Develop quarterly scorecard, to include on time accountability and quality of expected deliverables/metrics.
+ Position will require approximately 20% travel, to include periodic visits to the repackagers.
_Qualifications_
+ Bachelor’s degree in related field, or equivalent work experience, preferred
+ 8-10 years of experience within the pharmaceutical industry preferred
+ 5+ years of experience as a Manager performing Quality Control in a pharmaceutical manufacturing or packaging environment preferred with an emphasis on solid oral and oral liquid unit dose preferred
+ Effective problem solving and analytical skills able to lead and influence others to drive improvements.
+ Good knowledge in risk assessment and risk management
+ Strong working experience Corrective Action and Preventive Action programs
+ Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Excel and Power Point (statistics, graphing, presentations, etc.)
+ Excellent verbal and written communication skills.
+ Ability to travel 20%
_What is expected of you and others at this level_
+ Manages department operations and supervises professional employees, front line supervisors and/or business support staff
+ Participates in the development of policies and procedures to achieve specific goals
+ Ensures employees operate within guidelines
+ Decisions have a short term impact on work processes, outcomes and customers
+ Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
+ Interactions normally involve resolution of issues related to operations and/or projects
+ Gains consensus from various parties involved
Anticipated salary range: $103,500-$155,292
Bonus eligible: Yes
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: 11/10/2024 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
#LI-Remote
_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
