Sr Dir, QA


Oversee the Quality Assurance program for Response Management; the program for responding with maximum efficiency and effectiveness to Quality Issues, Complaints and significant audit and inspection findings.


  • Oversee direction of Quality Assurance Program for response management
  • Oversee the timely processing of CAPAs for all audit, inspections, issues and complaints
  • Ensure quality assurance organization and operating procedures are optimal to support audit program.
  • Perform quality assurance consulting projects, audits, and results analysis within budget and established timelines.
  • Chairing of the Critical Events Committee, and Serious Breach Evaluation Committee
  • Leading and enhancing the processes for determining event severity, and serious breach reporting
  • Host customer audits and regulatory inspections and preparing corrective action plans.
  • Participate in or lead teams for special projects as assigned. Teams may be cross functional.
  • Oversees the use and enhancements of the Events Driven Analysis (EDA ) system
  • Act as Process Owner for audit reporting, quality issue and complaint management, and end to end CAPA management processes
  • Monitor and optimize process efficiency and effectiveness through the use of metrics and goal setting
  • Liaise with Project Leaders, account and functional management to drive compliance and enhancements to the process and system production of performance and quality metrics
  • Oversees root cause analysis conduct and effectiveness checking
  • Oversees other core processes and business operations for QA
  • Interface with senior management to discuss quality and compliance issues
  • Interface with business development and operations to identify business opportunities
  • Recommend staff management actions in accordance with organization’s policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
  • Performs other duties as needed.

All responsibilities are essential job functions unless noted as nonessential (N).


  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive knowledge of pharmaceutical research and development processes and the regulatory environment.
  • Considerable knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation skills.
  • Ability to influence and guide others.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients


15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience; or equivalent combination of education, training and experience ; or equivalent combination of education, training and experience


Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.

Travel is required and may include some international travel.

EEO Minorities/Females/Protected Veterans/Disabled

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