Chief Quality Assurance Officer

2 weeks ago

Secaucus, New Jersey, United States Quest Diagnostics Full time

Position Overview

The Chief Quality Assurance Officer (CQAO) is a pivotal executive role tasked with formulating and implementing the quality and compliance strategy to ensure adherence to FDA regulations and other pertinent global standards. This position will focus on enhancing the quality assurance and compliance teams responsible for overseeing quality assurance, quality control, regulatory affairs, and compliance operations to support the development, manufacturing, and marketing of diagnostic products.

The CQAO will collaborate closely with cross-functional teams to uphold the highest standards of product quality, regulatory adherence, and operational excellence. This role is integral to the Executive Leadership Team and will report directly to the Chief Executive Officer.

Key Responsibilities

Strategic Direction:

  • Formulate and execute a comprehensive quality and compliance strategy that aligns with the organization's business objectives and regulatory obligations.
  • Provide strategic oversight and guidance to the Quality and Compliance departments.
  • Remain informed about industry developments, regulatory updates, and best practices to proactively tackle emerging challenges and seize opportunities.

Regulatory Adherence:

  • Design and implement strategies to ensure compliance with all relevant regulations and standards, including FDA, ISO, and other regulatory authorities.
  • Stay informed on regulatory changes and communicate their implications and necessary actions to relevant stakeholders.
  • Lead and coordinate regulatory inspections and audits, ensuring compliance with all regulatory bodies.

Quality Management:

  • Establish and maintain a robust quality management system, including policies, procedures, and documentation to guarantee product quality and compliance.
  • Implement and sustain processes for quality control, quality assurance, and risk management activities.
  • Monitor and analyze quality metrics, identify areas for enhancement, and implement corrective measures.

Product Development and Launch:

  • Collaborate with cross-functional teams to ensure that quality and regulatory requirements are integrated into product development processes.
  • Provide guidance and support throughout the design control process, including risk assessment, verification, validation, and documentation.
  • Ensure timely and compliant product submissions to regulatory authorities for new product launches.

Regulatory Strategy and Submissions:

  • Act as the primary liaison for FDA, EMA, and other regulatory agencies, maintaining established relationships with key leaders at these organizations.
  • Develop and execute regulatory strategies for product approvals, including pre-market notifications, 510(k) submissions, and pre-market approval applications.
  • Prepare and review regulatory submissions, ensuring accuracy, completeness, and compliance with regulatory standards.
  • Engage with regulatory authorities and participate in discussions to address regulatory matters.

Compliance Audits and Training:

  • Conduct internal audits to evaluate compliance with quality system requirements and regulatory standards.
  • Develop and deliver training programs to educate staff on quality and regulatory requirements.
  • Provide guidance and support to departments in implementing corrective actions identified through audits.

Team Development:

  • Build, develop, and manage a high-performing Quality Assurance and Compliance Team.
  • Ensure the organizational structure promotes collaboration, efficiency, and effectiveness.
  • Conduct a needs assessment to identify required skills and competencies and address any gaps within the current team.
  • Facilitate the development of the existing team to keep pace with the evolution of Quality Assurance and Compliance, ensuring that key stakeholders throughout the organization understand and support essential initiatives and projects.

Desired Outcomes:

  • Achieve compliance with new FDA regulations governing laboratory testing services, including the product development lifecycle.
  • Maintain a successful trajectory for IND submissions for near-term assets and strategically plan for future early-stage submissions.
  • Lead the successful submissions of multiple pipeline indications and assets for approval, supported by positive data readouts.
  • Foster strong and strategic relationships with health authority agencies in both domestic and international jurisdictions as appropriate.

Qualifications

  • A Bachelor's degree in a relevant field (e.g., engineering, life sciences) is required; an advanced degree is preferred.
  • A minimum of 10 years of leadership experience in quality assurance and regulatory affairs within the medical device or diagnostics industry.
  • In-depth knowledge of FDA regulations, ISO standards, and other relevant regulatory requirements.
  • A proven track record of successfully managing regulatory submissions and obtaining product approvals.
  • Strong leadership and management capabilities, with the ability to collaborate effectively across cross-functional teams.
  • Excellent communication and interpersonal skills.
  • Detail-oriented with strong analytical and problem-solving abilities.
  • Ability to adapt to evolving regulations and industry trends.

Quest Diagnostics is committed to equal employment opportunities and promotes a diverse and inclusive workplace.

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