Hybrid Associate Director – Quality Optimization

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About the role

  • Associate Director driving quality optimization for biopharmaceutical initiatives and regulatory compliance with project teams. Leading complex quality processes while collaborating with internal and external stakeholders.

Responsibilities

  • Provides consultation on particularly complex aspects of ‘GXP’ to project teams and sponsors
  • Drives the implementation of changes required to meet evolving regulatory requirements/industry developments
  • Leads or contributes expertise to process-related initiatives
  • Provides support to audits, inspections and Quality Issues, as assigned
  • Contributes expertise to designated initiatives
  • Provides expertise to project teams for issue management
  • Provides expertise for departments or geographies, as assigned
  • Contributes to regulatory inspections and sponsor audits, as assigned
  • Contributes to or leads designated initiatives (may be complex)
  • Directs others to resolve problems and/or conducts analyses (may be complex)
  • Decision Making - Makes decisions that impact the organization/department/business
  • Influence - Builds and extends relationships with new and existing internal and external customers
  • Provides expertise to identify, prevent, and solve problems (may be complex)
  • Drives solutions impacting the company
  • Stays abreast of new regulatory and policy developments
  • Accountable for the performance and direction of initiative teams were assigned as leader
  • Responsible for resourcing and budget negotiation for initiatives were assigned as leader
  • Directs and controls the activities of initiative teams were assigned as leader
  • May contribute to strategic planning from a quality or process perspective
  • May lead a team
  • Represents Corporate Quality and Syneos Health, as assigned
  • Performs other quality-related activities as directed by CQ management
  • Completes other Corporate Quality tasks, as assigned

Requirements

  • Minimum 4 Year / Bachelors Degree BA/BS degree in science or health care or equivalent education and experience
  • Requires detailed knowledge of GxP/regulatory/technical/process
  • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail
  • Above average attention to detail and accuracy
  • Strong organizational, interpersonal and team-oriented skills
  • Ability to act independently and pro-actively
  • Significant project management and customer management skills
  • Ability to perform several tasks simultaneously to meet deadlines

Benefits

  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program

Job title

Associate Director – Quality Optimization

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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