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SalaryJob Summary
The Director, Quality Management provides strategic oversight, leadership and direction to the Quality function and will be accountable for the CHPS (Cardinal Health Packaging Solutions – repackaging & bulk up) business unit within the Cardinal Health Pharmaceutical Segment.
What Quality Management contributes to Cardinal Health
Quality Management is responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications to ensure that products and services are reliable, safe and effective.
Demonstrates knowledge of quality systems and approaches.
Demonstrates an understanding of the relevant regulations, standards and operating procedures.
Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
Build and foster One Team Quality Culture.
Responsibilities
Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.
As the head of the Quality Team for CHPS, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.
Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner.
Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.
Must be able to approve emergency change controls but understanding the nature of the content including intermediate steps and make the link with the final product and any regulatory requirement.
Understands release product issue and evaluate their potential impact on product quality and compliance.
Escalates complex issues to leadership in a timely manner.
Manages professional employees, frontline supervisors and business support staff while maintaining strong relationships with customers.
Prioritizes and ensures work is delivered in an efficient way.
Provides daily problem solving.
Represents Quality in meetings related to his/her area of responsibility internally and externally.
Performs other duties as assigned.
Qualifications
Bachelors and Advanced degree in related field or equivalent work experience, preferred.
10+ years’ experience in Biopharma, Pharmaceutical or Medical Device regulated fields.
At least 7-10 years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device), ISO and/or DEA regulated environments.
Experience with equipment qualification, software validation, test method validation, and/or process validation.
Works well with others and understand how to be successful in a team environment, especially since customer facing.
Detail oriented, organized, able to multi-task, a self-starter and self-motivated.
Proficient in Microsoft Word and Microsoft Excel and possesses strong technical writing skills.
What is expected of you and others at this level
Provides leadership to managers, experienced quality professionals and 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: $112,500 - $181,650
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: 6/8/2024 *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.
