Assoc Dir, QA
Buenos Aires, Argentina
hace 2 días

Job Overview

Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes.

Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and / or global level.

Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity / efficiency improvement initiatives.

Manage the quality assurance oversight of projects, assignments, training and staff.

Essential Functions

  • Plan, schedule, conduct, report and close audit activities, as assigned
  • Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
  • Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
  • Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
  • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
  • Host customer audits and participate in review of corrective action plans,as assigned
  • Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
  • Serve as the QA Contact for assigned internal / external customers and IQVIA functional areas
  • Oversee documentation, reporting, and closure of compliance issues
  • Support Quality Management in proposal reviews and reporting QA metrics
  • Conduct trend analysis of audit results, provide to internal / external stakeholders as agreed, as assigned
  • Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
  • Participate in or lead (cross functional) teams for special projects as assigned
  • Promote the concept of quality, the principles of quality management and devise and implement quality improvements
  • Qualifications

  • Bachelor's Degree Req
  • 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience.
  • Equivalent combination of education, training and experience.

  • Knowledge of word-processing, spreadsheet, and database applications.
  • Strong knowledge of pharmaceutical research and development processes and regulatory environments.
  • Considerable knowledge of quality assurance processes and procedures'.
  • Strong interpersonal skills and the ability to positively influence and guide others.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation and leadership skills.
  • Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Identify functional constraints and identify solutions.
  • Ability to coordinate timelines with internal customers and external vendors.
  • Ability to manage multiple activities and timelines.
  • Ability to articulate and define departmental needs and processes.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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