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生产, 美国 | 2021-06-25


Job Title: Associate Director/Director, Quality Engineering Job Category: Exempt/Non-Exempt
Department/Group: Quality Assurance Travel Required: Minimal <5%
Location: Florham Park, NJ Position Type: Full Time
Level/Salary Range: Mid-Level Hiring Manager VP, Quality Assurance

Primary Functions

  • The Associate Director/Director, Quality Engineering will apply deep knowledge of GxP (clinical, non-clinical, pharmacovigilance, distribution) requirements and project management skills in establishing and maintaining robust, effective continual process improvement and quality risk management systems across clinical, non-clinical, safety/pharmacovigilance, and supply chain operations.
  • Promote a quality culture in design and execution of company operations and inspection readiness at all times.


Major Responsibilities and Duties

  • Identify, analyze, and prioritize opportunities for improvements utilizing available data sources, e.g. self-identified process and system gaps, non-compliance and deviations, audit and inspection findings, CAPA. Develop plans for continual improvement from the identified, prioritized needs. Lead and/or manage process improvement projects for timely implementation with budget. Ensure projects are aligned with business strategy and coordinated with other business activities and improvement projects to accomplish each project’s goals.
  • Ensure Quality Risk Management program is well-established to assess, control, communicate, and review risks throughout product and clinical trial lifecycles.
  • Liaise with Clinical Quality Control ensuring adequate identification and communication of clinical trial compliance risks which inform Quality Management System processes, such as the annual audit and process improvement plans.
  • Ensure mechanisms are in place to monitor and adapt to changes in legislation and the regulatory environment.
  • Establish and report meaningful metrics within the Quality Management System.
  • Lead periodic Management Review of the Quality System.
  • Lead annual audit planning.
  • Participate in SOP development and periodic review.


Qualifications and Education Requirements

  • Bachelor degree or higher in scientific, medical, quality or related discipline.
  • 8+ years of experience in the pharmaceutical industry, including 5+ years in Quality Engineering / Process Improvement.
  • Project management experience (PMP desirable).
  • Continual process improvement experience, and knowledge of methodologies, tools and change vehicles (e.g. leans six-sigma, Kaisen).
  • Comprehensive understanding of the drug development process, risk management principles and process, quality audits, health authority inspections, root cause analyses and mitigation strategies as well as corrective and preventive actions.
  • Knowledgeable in GxP (clinical, non-clinical, pharmacovigilance, distribution) regulations and guidance (e.g. ISO, FDA, EU, ICH) including upcoming changes.
  • Previous experience or advanced understanding of fundamentals of clinical risk management, ICH E6 R2, and upcoming revisions to ICH.
  • Demonstrated critical thinking and problem-solving in the application of global regulations.
  • Ability to deal tactfully and confidently with customers at all levels
  • Demonstrated leadership with proactive, collaborative support to cross-functional peers. A team player with strong influencing and negotiation skills
  • Flexibility to respond to changing business needs.
  • Ability occasionally to work outside of business hours in home time zone to accommodate global team time zones.
  • Experience using data analytics tools and systems preferred.
  • Strong verbal and written communication.
  • Ability to travel up to 5%.