Manager, Quality Assurance
US-Nationwide-FIELD
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 repackager compliance 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.
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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.
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401k savings Access to wages before pay day Access to wages before pay day with myFlexPay Dental Dental coverage Disability coverage Flexible Spending Accounts Health savings account Healthy lifestyle programs HSA Medical Medical coverage Medical, Dental and Vision coverage Paid parental leave Paid Time Off Paid time off plan Parental leave Vision Vision coverage
Tasks- Collaborate with contract repackagers
- Develop systems and procedures
- Manage change control and complaints
- Oversee quality systems
- Review investigations and protocols
Change Control Collaboration Communication Complaint Investigation Compliance Computer Continuous Improvement Corrective Action Excel Graphing Investigation Investigations Management Microsoft Office Presentation Preventive Action Quality Assurance Regulatory Compliance Risk Assessment Risk Management Statistical analysis Training Validation protocols Verbal communication Written communication
Experience8 years
EducationBachelor's degree Equivalent work experience Related Field
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9