Associate Director

3 days ago


Western Springs, Illinois, United States ProPharma Group Full time
Job Title: Associate Director

ProPharma Group is seeking an experienced Associate Director to join our team. As a key member of our leadership team, you will be responsible for leading our Computer System Validation (CSV) and Data Integrity practice.

Key Responsibilities:
  • Lead audits and gap assessments for compliance with health authority regulations
  • Author policies, procedures, and work instructions for CSV and data integrity
  • Provide guidance on CSV and data integrity approaches
  • Manage teams of internal resources in executing CSV and data integrity strategies
  • Develop and deliver original CSV content on current topics
  • Teach CSV, software quality compliance, and data integrity classes
  • Participate in business strategy development for growth of CSV and Data Integrity practice
  • Assist in marketing and sales activities
  • Assist in business development and operations
Requirements:
  • Certified auditor
  • Minimum 3 years audit experience
  • Minimum 15 years in Pharma/Med Device industry
  • Experience in validation of computer systems and data integrity
  • Expert knowledge of FDA 21 CFR 11, EU Annex 11, and supporting guidance documents
  • Expert knowledge of industry best practices such as GAMP5, ANSI standards, and ASTM
  • Proficiency in public speaking
What We Offer:

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.

ProPharma Group is an Equal Opportunity Employer and provides a safe space where all employees feel empowered to succeed.



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