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Director, Quality Assurance

Chicago, Illinois

Post Date: 09/08/2017 Job ID: 1444 Job Category: Clinical: Clinical Operations and Development

With an in-depth knowledge of the Quality System Regulations and FDA requirements, provides leadership for the Quality Assurance department and the company. Develops the quality strategy and ensures that the strategy integrates with other types of risks. Leadership role that requires sound judgment and the ability to assess the likelihood and impact of Quality risks for the company. Establishes relationships with key external vendors and Quality leaders and serves as the Subject Matter Expert for the company in the area of Quality and Validation.

Job Responsibilities:
  • Develop and implement the Quality 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 QA requirements of the company Quality System Manual. Maintain procedures and policies; ensure that QA 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 QA 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 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, creates, and reviews department Standard Operating Procedures (SOPs).
  • Collaborate with Operations and Business Development personnel to finalize project budgets and scope of work; assists with RFP / RFI completion.

Qualifications/ Requirements:
  • 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 10+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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