Director of Quality Assurance

Sitero is a growing company that is seeking a Director, Quality Assurance to lead the Sitero Quality Assurance group to support our global Clinical and Life Sciences services and software offerings.

You will lead our team of high-performing professionals to be efficient, productive and effective in establishing Quality Assurance processes and systems to ensure all Sitero solutions follow industry best practices and quality standards.

This role will require extensive knowledge of quality systems and the Life Sciences industry. We are seeking a leader that can grow and mentor a Quality organization and work collaboratively with cross-functional teams to drive a Quality focused culture throughout the company.

Principal Duties & Responsibilities

  • Accountable for the overall design, implementation and improvement of quality systems and internal / external audit strategies to ensure continuous improvement, performance and security are all a key focus of the delivery and IT organizations (Clinical services, IRB/IBC, Pharmacovigilance and other related clinical services and software solutions)

  • Develop, design and implement strategic SOPs for all internal and external processes and solution offerings

  • Manage all Life Sciences customer audits and global Regulatory inspections

  • Assures quality and regulatory compliance related to GxPs, Clinical services, IRB/IBC, Pharmacovigilance and other related activities performed by medical and clinical teams

  • Develop and execute a Quality Assurance strategy and system to ensure all internal delivery processes, teams and solutions are compliant and follow quality best practices

  • Ensure all Sitero products, processes and solutions are delivered with compliance and quality by establishing quality standards with proper data driven monitoring to detect and pro-actively correct non-compliance

  • Establish quality and reliability standards by studying customer and regulatory requirements with other members of management and with domain delivery teams

  • Drive end-to-end services and software quality, while focusing on ensuring strong customer experiences and instilling quality as a core discipline into every aspect of service delivery and the company as a whole

  • Develop, track, report and act upon metrics, SLAs and KPIs that provide transparency and continuous improvement of quality systems and delivery effectiveness from a quality perspective

  • Lead continuous improvement initiatives with defined benchmarks and measures that focus on delivery quality

  • Manage ISO certification process and on-going ISO compliance

  • Define and manage standards for reporting and tracking of quality issues, missed internal / external SLAs and their resolution across the entire delivery and software development lifecycle

  • Collaborate closely with delivery teams to meet KPIs / SLAs to ensure client satisfaction, with an ever-increasing level of quality

  • Build and lead a strong and effective quality assurance team through mentoring, continuous communication, performance evaluations, resolving conflicts, and promoting a culture of excellence

Required Skills & Qualifications

  • 5-8+ years of Quality Assurance experience in Life Sciences services and/or software

  • Experience with effectively managing regulatory agency inspections is required

  • BSc/BA in Life Sciences and/or Quality related discipline

  • Experience implementing and maintaining ISO and related quality certifications

  • Leadership skills, with strong communication, steadfast resolve and personal integrity

  • Understanding of advanced quality systems, business planning and Clinical / Regulatory compliance issues and regulations

  • Strong organizational and leadership abilities

  • Aptitude in decision-making and problem-solving

  • Ability to diagnose problems quickly and foresee potential issues

To apply for this position please send your updated resume and cover letter to CAREERS@SITERO.COM