Vice President, QRA Pharmaceutical Segment

in Remote Location

Vice President, QRA Pharmaceutical Segment Job

Job Description Job Attributes+

  • Job ID

    1ab650cd-6577-4183-8ca5-702e946d3593

  • Req #

    20090322

  • Job Location

    Remote Location

  • Job Category

    Quality

  • Job Type

    Regular

  • Schedule

    Full time

The Vice President, Quality and Regulatory Affairs for the Pharma Segment is primarily responsible for:

  • Providing general oversight to ensure the identity, strength, quality and purity of the drug product.
  • Maintaining the highest level of product quality and regulatory compliance thereby ensuring patient safety.
  • Ensuring that all cGMP requirements are met in the manufacture of the drug product.
  • 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, DEA and other regulatory agency inspections and responding to any inquiries / observations appropriately.
  • Identifying key regulatory issues for senior management and developing / deploying remediation.

    Additional Responsibilities

  • Provides overall direction and management of the quality and compliance function that supports all Pharmaceutical manufacturing, contract manufacturing and private labeling sites that manufacture products for Cardinal Health’s Pharma Segment and the business groups therein.
Is responsible for all quality and compliance functions including but not limited to: FDA inspection management and response, site and regional quality management, microbiology management, change control, supplier management, management review, development of quality policies and practices, training, and records management.Provides advice, guidance and training to Quality and Compliance  staff in the execution of their duties.Interacts with regulatory agencies, as necessary.Establishes and implements policies and procedures related to quality, compliance and sterilization/microbiology and 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.Lead the periodic management review meetings.Maintain communication with key business leaders to ensure complete awareness of relevant issues and how the impact to business strategy to develop the corresponding action plan.Escalates significant regulatory issues to senior management.Recruit and retain talented and diverse leaders with a robust succession plan.Provide overall oversight of regulatory compliance for all manufacturing sites.

Required Competencies

Experience with pharmaceutical manufacturing in accordance with minimally CFR Part 210/211 for traditional drug manufacturing and ideally, also Part 212 for PET manufacturing.Also experience with sterile drug manufacturing experience.Excellent 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 Authority

The VP, QRA 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 Qualifications

Bachelor’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 microbiological principles and practices in the pharmaceutical industry

The Colorado Department of Labor requires all employers to provide the following information for all positions that could be performed in the state of Colorado

Anticipated salary range: $150,200 - $311,900Bonus eligible: YesBenefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

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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