Vice President Quality US Manufacturing Job
Job Description Job Attributes+
The Vice President, Quality US Manufacturing for the Medical Segment is primarily responsible for:
- Providing general leadership of nearly 20 US manufacturing sites and the design control quality engineering function for the Medical Segment.
- Maintaining the highest level of product quality and regulatory compliance thereby ensuring patient safety.
- Ensuring that all QSRs/cGMP requirements are met in the manufacture of various medical device products.
- Ensuring that all manufacturing processes are carried out appropriately, all procedures are followed and all issues are appropriately investigated / corrected.
- Providing guidance relative to managing FDA and other regulatory agency inspections and responding to any inquiries / observations appropriately.
- Identifying key quality, manufacturing and regulatory compliance issues for senior management and developing / deploying remediation.
- Provides overall direction and management of the quality and compliance function that supports all US manufacturing sites that manufacture products for Cardinal Health’s Medical Segment and the business groups therein.
Required CompetenciesExcellent interpersonal, organizational and communication skillsDemonstrated leadership and the ability to motivate othersProficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices in the cGMP regulatory field
Level of AuthorityThe VP, Quality US Manufacturing has the authority to: develop, review and revise quality policies and proceduresmake budget related decisionsapprove all quality documentsapprove change control documents (any level change)provide direction for CAPA managementdetermine, develop and deliver trainingmake HR decisions for direct reportsapprove personnel related issues (PTO, travel, etc.)develop and deploy employee goals, objectives and performance evaluationscarry out other duties as described in policies and proceduresIssue quarantines and recommend recalls as part of investigations.
Required QualificationsBachelor’s required and Advanced degree preferred in related technical field (Chemistry, Biology, Engineering, etc.) or equivalent work experience, preferred10-15 years of experience in the pharmaceutical / medical device / biologics industryMinimum of 10 years of experience in senior quality management roleThorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirementsExtensive experience dealing with FDA in inspectional situations and response activitiesWorking knowledge of manufacturing and design control principles and practices in the medical device industry
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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.