The Role
The Senior Vice President (SVP) of Quality Assurance and Regulatory Affairs is a senior executive role responsible for establishing and driving the quality and regulatory strategy to ensure compliance with FDA regulations and other relevant global standards. This position will continue to build and enhance the quality assurance and regulatory affairs team that will oversee quality assurance, quality control, regulatory affairs, and compliance activities to support the development, manufacturing, and commercialization of diagnostic products.
The SVP will work closely with cross-functional teams to maintain the highest standards of product quality, regulatory compliance, and operational excellence. This role will be a member of the Executive Leadership Team, and will report to the Chief Executive Officer.
Responsibilities
Strategic Leadership:
- Develop and execute a comprehensive quality and regulatory strategy aligned with the company’s business goals and regulatory requirements.
- Provide strategic leadership and direction to the Quality and Regulatory Affairs departments.
- Stay abreast of industry trends, regulatory changes, and best practices to proactively address emerging challenges and leverage opportunities.
Regulatory Compliance:
- Develop and implement strategies to ensure compliance with all applicable regulations and standards, including FDA, ISO, and other regulatory bodies.
- Stay updated on changes in regulatory requirements and communicate the impact and necessary actions to relevant stakeholders.
- Coordinate and lead regulatory inspections and audits, ensuring compliance with all regulatory agencies.
Quality Assurance:
- Develop and maintain a robust quality management system, including policies, procedures, and documentation to ensure product quality and compliance.
- Implement and maintain processes for quality control, quality assurance, and risk management activities.
- Monitor and analyze quality metrics, identify areas for improvement, and implement corrective actions.
Product Development and Launch:
- Collaborate with cross-functional teams to ensure quality and regulatory requirements are integrated into product development processes.
- Provide guidance and support in the design control process, including risk assessment, verification, validation, and documentation.
- Ensure timely and compliant product submissions to regulatory agencies for new product launches.
Regulatory Strategy and Submissions:
- Serve as the primary interface for FDA, EMA and other regulatory agencies and have well established relationships with key leaders at these agencies.
- 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 adherence to regulatory requirements.
- Liaise with regulatory authorities and participate in meetings and discussions to address regulatory matters.
Compliance Audits and Training:
- Conduct internal audits to assess compliance with quality system requirements and regulatory standards.
- Develop and deliver training programs to educate employees on quality and regulatory requirements.
- Provide guidance and support to departments in implementing corrective actions identified through audits.
Build, develop and manage a high performing Quality Assurance and Regulatory Affairs Team:
- Ensure the organizational design allows for collaboration, efficiency & effectiveness.
- Lead a needs assessment to determine required skill and competencies needed & identify any gaps in the current team.
- Ensures development of the existing team to keep up with the evolution of QA/RA and collaborates to ensure key stakeholders throughout the enterprise are able to understand and support our key initiatives/projects.
Desired Outcomes:
- Compliance with the new FDA rule that regulates laboratory testing services, including the product development lifecycle.
- Continue the successful path to IND submissions for near term assets and plan accordingly for future early-stage submissions in the pipeline.
- With positive data readouts, lead the successful submissions of multiple pipeline indications and assets for approval.
- Foster close and strategic relationships with health authority agencies in US and ex-US jurisdictions as appropriate.
Required 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 industry, diagnostics field, or other related 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 skills, 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 changing regulations and industry trends.
Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.
