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Senior Director, Head of Quality

Chicago, IL

Posted: 10/12/2018 Job Category: Clinical: Quality Job Number: 2155

With an in-depth knowledge of the Quality System Regulations and FDA requirements, the Senior Director, Head of Quality provides leadership for the Quality department and the company. S/he develops the quality strategy and ensures that the strategy integrates with other types of risks. This leadership role requires sound judgment and the ability to assess the likelihood and impact of Quality risks for the company. You will establish  relationships with key external vendors and Quality leaders and serve  as the Subject Matter Expert for the company in the area of Quality and Validation. (Reports to the Chief Medical Officer.)


Primary Responsibilities
  • Develop and implement the Quality and Compliance Strategy with both senior leadership and business functions within the company.  Translate the strategy and vision into goals, objectives and measures for the organization.
  • Assure adherence of Quality requirements of the company Quality System Manual.   Maintain procedures and policies; ensure that Quality maintains compliance with changes to the company Quality System Manual.
  • Partner with company Leadership to conduct Quality Management Reviews and institute enterprise management controls to assess and manage risk.
  • Create a culture of enterprise risk management, education and skill development to operationalize effective risk management processes and practices.
  • Provide  overall  direction  and  leadership  for  the  Quality  organization  with  robust  talent  and organization development plans.  Provide the coaching, mentoring and leadership to transform the staff from subject matter experts to a cohesive, integrated team of consulting experts.
  • Provide leadership in preparation for, manage and lead follow up of Sponsor audits and Regulatory  Authority inspections.
  • Provide leadership and direction in terms of the company’ s ISO 9001: 2015 certification; ensure  standard is understood and established across all service lines and functions of the company
  • Provide leadership and direction to ensure the whole company operates within one, harmonized  Quality Management System.
  • Closely collaborate with IT to provide leadership and oversight for proper validation, maintenance and change control of all GxP relevant IT systems and applications.
  • Provide strong leadership in establishing, maintaining, and meeting budgetary requirements.
  • Develop and manage the relationships with key company internal and external Quality leaders.
  • Serve as the Quality Champion in the organization, building awareness and understanding of quality and compliance requirements.
  • Drive a positive cultural change and clear employee accountability for quality and compliance.
  • Remain current with regulatory changes, best practices and new trends in the industry and their impact upon the company bringing appropriate thought leadership to QA in alternative methods to meet the regulations.
  • Form  and  lead  sub-teams  comprised of  individuals  from  the  company’ s  various  functions  and strategic vendors to address a specific business goal, risk, or solution.

Managerial Responsibilities
  • Responsible for the strategic development of the department.
  • Define departmental platform policies and guidelines.
  • Ensure development of departmental team.
  • Oversee departmental staff and hold responsibility for performance management, for recruitment/retention of personnel, and for expense approval and budgeting.
  • Supervise staff and consultants, as needed. Direct resource planning, budgeting, and restructuring to meet project and organizational/corporate needs.
  • Serve on pertinent internal committees.
  • Provide an atmosphere which is conducive to teamwork.
  • Identify need for, create, and review department Standard Operating Procedures (SOPs).
  • Collaborate with Operations and Business Development personnel to finalize project budgets and scope of work; assist  with RFP / RFI completion.


  • Bachelor' s degree in a Science discipline or a related field preferred or relevant systems experience.
  • A Master’ s degree is highly desirable but not required.
  • Must have 15+years of relevant experience including interfacing with outside regulatory agencies.
  • Experience  must  include  leadership  and  a  mix  of  significant  quality  knowledge  and  regulatory compliance responsibility. Past experience in Healthcare sector is expected.
  • Ability to develop a deep understanding of the company’ s business strategy, quality, and compliance requirements and existing quality systems environment.
  • Track record of execution on large scale programs that meet quality, time, and budget requirements.
  • Proven experience in managing staff who administer quality systems, including document control, training, supplier qualification, internal audit, nonconformance, CAPA, reporting metrics, leading Management Reviews, and validation services.
  • Understanding of Quality Management System standards and best practices such as 21 CFR (GCP, GLP, GMP), ICH, ISO, Six Sigma, Kaizen, ANSI.
  • Proven track record of sound judgment including abstract thinking and a good balance between an academic and pragmatic approach.
  • Excellent communication skills with being able to formulate vision and translate vision into execution with measurable results.
  • Strong people skills, ability to work with stakeholders inside and outside of the company, able to mentor team members, build and lead teams with diverse backgrounds.
  • Must  be  convincing  champion  for  change  to  build  quality  and  compliance  culture  across  the organization.
  • Effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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