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Associate Director Quality Assurance Resume

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MD

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OBJECTIVE

  • A professional position where my leadership skills in quality management will contribute to organizational compliance, effectiveness and business excellence.

SUMMARY

  • More than 30 years of diversified and progressive quality experience within the biopharmaceutical industry. Demonstrated expertise in the development, implementation and improvement of quality systems. Effective in identifying and resolving systemic problems. Excellent written, verbal and interpersonal communication skills.

PROFESSIONAL EXPERIENCE

Associate Director Quality Assurance

Confidential, MD

Responsibilities:

  • Design, implementation and management of SalesForce.com for Complaint Management
  • Monitor and trend Customer Complaints for IVD Regulated products
  • Evaluate events for medical device reporting
  • Initiate investigations for confirmed adverse events
  • Facilitate Product Recalls and Field Notice Issuance
  • Manage CAPA System
  • Manage Deviation and Material Nonconformity Processes
  • Provide direction and development for department personnel

Sr. Manager

Confidential

Responsibilities:

  • Developed strategy and implemented global enterprise solution (MasterControl) for EDMS
  • Ensured regulatory compliance of the Document Control Library
  • Managed the document change control system
  • Established policies and procedures for document development, retention and disposition
  • Managed and maintained the electronic document management system
  • Developed and delivered training for the document control library and change control system
  • Supervised and developed staff

Sr. Quality Systems Manager

Confidential

Responsibilities:

  • Managed Deviation, CAPA and Change Control Systems
  • Managed document archive
  • Maintained databases and controlled electronic documentation
  • Controlled and Issued GMP labels
  • Controlled and issued production batch records
  • Reviewed and revised master documents and policies
  • Collaborated with document users in developing user - friendly documentation
  • Designed and conducted training for all quality systems
  • Identified and directed training for department personnel
  • Developed internal and supplier auditing schedules
  • Conducted internal and supplier audits for regulatory compliance
  • Designed and generated quality system metrics for management review
  • Provided daily supervision of department staff

Quality Specialist

Confidential

Responsibilities:

  • Managed raw material program
  • Quality liaison for development of OOS procedure
  • Review/modified internal auditing procedure
  • Quality participant on product project team
  • Coordinated major change in the documentation of material specifications
  • Developed material parts list
  • Developed a comprehensive supplier base list

Quality Specialist

Confidential

Responsibilities:

  • Launched internal auditing program
  • Mentored auditors
  • Mapped and streamlined test sampling process
  • Mapped and streamlined batch record review process
  • Mapped and streamlined training administration process

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