Director, Quality Management - PET - Cardinal Health
Boston, MA
About the Job
_Job Summary_
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.
Cardinal Health PET manufacturing facilities complete multiple manufacturing runs each day and distribute the radiopharmaceuticals to our more than 100 nuclear pharmacies across the country, which allows our customers flexibility when scheduling patient doses. Doses we manufacture are delivered when you need them.
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.
_What Quality Management 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 Management provides strategic oversight, leadership and direction within the Quality function.
_Responsibilities_
+ Leads 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.
+ Is 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. Provide controls to ensure proper disposition of raw materials and finished products. Ensure that the procedures are properly followed and adequate for their intended use.
+ Establishes implements and monitors quality performance measures for the site.
+ Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures.
+ Assess 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.
_Qualifications_
+ 12+ years of experience preferred
+ Bachelor’s degree in related field, or equivalent work experience preferred
+ Ability to travel 25-50%
+ Willing to be on call at any time of day
_What is expected of you and others at this level_
+ Provides leadership to managers and experienced professional staff; may also manage front line supervisors
+ Manages an organizational budget
+ Develops and implements policies and procedures to achieve organizational goals
+ Assists in the development of functional strategy
+ Decisions have an extended impact on work processes, outcomes, and customers
+ Interacts with internal and/or external leaders, including senior management
+ Persuades others into agreement in sensitive situations while maintaining positive relationships
Anticipated salary range: $114,200 - $184,380
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: 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. 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)
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.
Cardinal Health PET manufacturing facilities complete multiple manufacturing runs each day and distribute the radiopharmaceuticals to our more than 100 nuclear pharmacies across the country, which allows our customers flexibility when scheduling patient doses. Doses we manufacture are delivered when you need them.
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.
_What Quality Management 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 Management provides strategic oversight, leadership and direction within the Quality function.
_Responsibilities_
+ Leads 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.
+ Is 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. Provide controls to ensure proper disposition of raw materials and finished products. Ensure that the procedures are properly followed and adequate for their intended use.
+ Establishes implements and monitors quality performance measures for the site.
+ Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures.
+ Assess 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.
_Qualifications_
+ 12+ years of experience preferred
+ Bachelor’s degree in related field, or equivalent work experience preferred
+ Ability to travel 25-50%
+ Willing to be on call at any time of day
_What is expected of you and others at this level_
+ Provides leadership to managers and experienced professional staff; may also manage front line supervisors
+ Manages an organizational budget
+ Develops and implements policies and procedures to achieve organizational goals
+ Assists in the development of functional strategy
+ Decisions have an extended impact on work processes, outcomes, and customers
+ Interacts with internal and/or external leaders, including senior management
+ Persuades others into agreement in sensitive situations while maintaining positive relationships
Anticipated salary range: $114,200 - $184,380
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: 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. 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
