University of Massachusetts Medical School

Director, Quality Assurance - QARC

Minimum Salary US-RI-Lincoln
Job Location 1 week ago(11/21/2020 7:50 AM)
Requisition Number
2020-36036
# of Openings
1
Posted Date
Day
Shift
Exempt
Exempt/Non-Exempt Status
Non Union Position -W60- Non Unit Professional

Overview

POSITION SUMMARY: 

The Director, Quality Assurance QARC will lead and grow QARC’s quality assurance group and provide a strong foundation of GCP expertise to ensure the development and management of a comprehensive, compliant quality management system.  The Director will work closely with clinical operations, information technology, physics and dosimetry and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities. The Director will implement a risk-based quality management system that encompasses quality control and quality assurance across all services that QARC provides.

Responsibilities

ESSENTIAL FUNCTIONS:

  • Provide leadership and oversight to quality assurance department, working alongside peers and direct reports to ensure the implementation of a robust quality management system and structure.
    • Provide quality oversight of internal operations.
    • Leverage expertise and experience to provide interpretation of GCP and applicable regulatory regulations and/or guidelines.
    • Promote a culture of continuous improvement, and cross-functional problem-solving.
    • Ensure organizational operations are compliant with GCP and applicable FDA, ICH, EMA and industry requirements and standards.
    • Develop and lead the GCP quality organization, coaching and mentoring direct reports.
  • Guide the cross-functional development of written procedures in alignment with applicable guidance and regulations; establish and implement quality policies and procedures.
  • Ensure inspection readiness by performing and/or addressing gap assessments and initiating continuous improvement projects.
  • Develop, deliver, and/or manage training for colleagues on quality assurance topics and written procedures.
  • Apply risk-based decision making through all facets of the job.
  • Develop audit plans and perform audits and assessments of internal systems; guide direct reports and potentially leverage non-QA staff to assist in audits and assessments.
  • Host and manage sponsor audits and regulatory inspections; support cross-functional development of communications and CAPAs in response to audits and inspections.
  • Maintain a working knowledge of ICH GCP guidance, FDA, EU, UK and applicable regulations, including privacy requirements.
  • Adapt to new responsibilities and duties as required.
  • Perform other duties and/or projects as assigned.

Qualifications

REQUIRED QUALIFICATIONS:

  • BA/BS in associated functional discipline
  • 5-8 years in the pharmaceutical or biotech industry, at least 5 years of which must be in a quality assurance management or director level. At least 3 years of direct GCP auditing experience.
  • The ideal candidate will be a strong quality assurance “generalist” comfortable with managing the full spectrum of quality assurance responsibilities, establishing new systems, adjusting to the scale of a small niche vendor, and finding creative, realistic solutions to compliance that fit an established organization.
  • Prior experience and competence with the following areas:
    • Quality management system development and management, including writing of standard operating procedures
    • Root cause analysis, risk assessment, and development/management of effective CAPAs and associated systems
    • Computer system validation, computerized systems
    • GCP auditing, internal system audits, and hosting and responding to sponsor audits
    • Gap assessments and risk-based continuous improvement
  • Interpersonal and management skills:
    • Stellar interpersonal, writing and presentation skills for communicating with colleagues, sponsors, regulators, and stakeholders
    • Ability to manage multiple projects in a dynamic environment
    • Ability to work efficiently, independently, and to adapt to changing responsibilities and priorities based on risk
    • Ability to analyze, interpret, and solve complex problems
    • Ability to think strategically and objectively and with creativity and innovation

Additional Information

PREFERRED QUALIFICATIONS:

  • Background in oncology and radiation therapy is preferred.

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