Cardinal Health
Director, Quality Management - PET
Cardinal Health, Honolulu, Hawaii, United States, 96814
Cardinal Health Director, Quality Management - PET Honolulu, Hawaii Apply Now
Positron Emission Tomography (PET) scanning is one of the most frequently used molecular imaging procedures used in healthcare. Cardinal Health is an essential element within the PET marketplace. We have one of the largest PET footprints in the US and deliver hundreds of thousands of PET radiopharmaceutical doses per year through the largest U.S. network of nuclear pharmacies.The Director, Quality Management – PET will be responsible for leading a team of 8 Regional Quality Managers and their direct reports and will provide direction & management of the QA function that supports the 30 PET manufacturing sites in the United States.ResponsibilitiesLeads team of direct reports including all Regional Quality Managers in the PET organization.Provides overall direction and management of the QA function that supports all the PET manufacturing sites in the United States.Responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues, compliant investigation, review and approval of validation protocols and summary reports and site related records management.Provides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols/reports, investigations, procedures and change controls.Interacts with regulatory agencies, as necessary.Establishes and implements procedures related to quality, facilities and equipment, materials, production, packaging, labeling and laboratory control systems.Establishes implements and monitors quality performance measures for the site.Assesses data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP's and regulatory requirements.Provides QA support of various business projects/goals including but not limited to sponsor product support, technology transfer, equipment installation and qualification.Continuous professional development of Regional Quality Managers and Quality Assurance Specialists.Qualifications12+ years of experience preferredBachelor’s degree in related field, or equivalent work experience preferredAbility to travel 25-50%Willing to be on call at any time of dayWhat is expected of you and others at this levelProvides leadership to managers and experienced professional staff; may also manage front line supervisorsManages an organizational budgetDevelops and implements policies and procedures to achieve organizational goalsAssists in the development of functional strategyDecisions have an extended impact on work processes, outcomes, and customersInteracts with internal and/or external leaders, including senior managementPersuades others into agreement in sensitive situations while maintaining positive relationshipsAnticipated salary range:
$114,200 - $184,380Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveApplication window anticipated to close:
9/27/2024 *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.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.
#J-18808-Ljbffr
Positron Emission Tomography (PET) scanning is one of the most frequently used molecular imaging procedures used in healthcare. Cardinal Health is an essential element within the PET marketplace. We have one of the largest PET footprints in the US and deliver hundreds of thousands of PET radiopharmaceutical doses per year through the largest U.S. network of nuclear pharmacies.The Director, Quality Management – PET will be responsible for leading a team of 8 Regional Quality Managers and their direct reports and will provide direction & management of the QA function that supports the 30 PET manufacturing sites in the United States.ResponsibilitiesLeads team of direct reports including all Regional Quality Managers in the PET organization.Provides overall direction and management of the QA function that supports all the PET manufacturing sites in the United States.Responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues, compliant investigation, review and approval of validation protocols and summary reports and site related records management.Provides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols/reports, investigations, procedures and change controls.Interacts with regulatory agencies, as necessary.Establishes and implements procedures related to quality, facilities and equipment, materials, production, packaging, labeling and laboratory control systems.Establishes implements and monitors quality performance measures for the site.Assesses data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP's and regulatory requirements.Provides QA support of various business projects/goals including but not limited to sponsor product support, technology transfer, equipment installation and qualification.Continuous professional development of Regional Quality Managers and Quality Assurance Specialists.Qualifications12+ years of experience preferredBachelor’s degree in related field, or equivalent work experience preferredAbility to travel 25-50%Willing to be on call at any time of dayWhat is expected of you and others at this levelProvides leadership to managers and experienced professional staff; may also manage front line supervisorsManages an organizational budgetDevelops and implements policies and procedures to achieve organizational goalsAssists in the development of functional strategyDecisions have an extended impact on work processes, outcomes, and customersInteracts with internal and/or external leaders, including senior managementPersuades others into agreement in sensitive situations while maintaining positive relationshipsAnticipated salary range:
$114,200 - $184,380Benefits:
Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveApplication window anticipated to close:
9/27/2024 *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.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.
#J-18808-Ljbffr