Director, Quality and Regulatory
At Element Biosciences, we are passionate about our mission to develop high performing products to study genomics with unprecedented flexibility and quality that enable researchers to better understand biology for the improvement of global health. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.
We are looking for a dynamic, driven, and passionate leader to build and grow a Quality organization in a fast-paced and high-growth environment. Our Director of Quality and Regulatory will establish, direct, and ensure all quality-related functions including quality engineering, quality systems, regulatory compliance, document control, auditing, and supplier management to meet global regulations and standards, company policies, and local procedures. Incumbent will build upon a strong quality system foundation and ensure it is maintained efficiently, report quality system performance to management, and promote awareness of regulatory and customer requirements throughout the organization. We are looking for a strong, highly integrative individual capable of building a robust quality plan that allows for fast product development cycles.
If you possess the following and want to make a meaningful impact, we invite you to explore this role.
Essential Functions and Responsibilities:
- Develop quality policies, annual goals, and objectives in alignment with company goals and objectives.
- Develop and implement a strategy for quality systems that aligns with internationally recognized standards.
- Responsible for the organization’s regulatory strategy for all product pipelines, including filings and submissions, as applicable.
- Lead and prepare the organization for inspection readiness; interact with regulatory authorities, consultants and defend the organization’s state of compliance, as directed.
- Responsible for global regulatory compliance to ensure products and processes adhere to applicable domestic and international regulations and standards.
- Maintain product compliance certifications and ensure associated documentation is up to date.
- Direct activities to ensure adequate documentation for assessment of product concerns or conditions that must be considered for field action/recall decisions.
- Establish and direct incoming inspection, quality controls, and quality release for all products.
- Direct the supplier quality program to ensure R&D, manufacturing, and service providers are classified for risk. Conduct supplier audits and assessments. Establish quality agreements with critical suppliers.
- Establish effective quality procedures and project plans for new product development and technology transfer projects to ensure that regulatory and company quality system requirements are met.
- Direct the activities associated with transfers to manufacturing of all new products and technology changes. Ensure changes to commercialized products are subject to robust technical and regulatory review.
- Ensure the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the Quality and Regulatory functions.
- Other duties as assigned.
Education and Experience:
- B.S. degree in Engineering, or equivalent field of study, with at least 15 years of relevant experience (an equivalent combination of experience and education may be considered).
- Advanced degrees are preferred.
- Relevant experience in the life science industry is preferred. Experience with NGS, IVD, and SaMD are preferred.
- American Society of Quality (ASQ) certifications (CQE, CQA, CMQ/OE, etc.) are preferred.
- Ability to interpret regulations (QSR, ISO, etc.) into standards and procedures as required and explain these interpretations to all levels of the organization including regulatory bodies.
- Ability to make decisions with high integrity and understand how to assess and mitigate risk.
- Must be a self-starter that enjoys a great deal of freedom of action, innovation, and critical analysis. Highly variable operations are performed daily from complex engineering decisions to routine administrative functions.
- Ability to work in a fast-paced and technically challenging environment where personal drive is critical to success. Quality plan implementation is largely dependent upon the person’s ability to recognize the most efficient, cost effective, and strategic approach to attaining the desired goal.
- Experience and comprehensive understanding of design control requirements.
- Fundamental knowledge of validation principles.
- Comprehensive understanding of auditing principles.
- Excellent communication skills (verbal, written, and presentation) that facilitate strategy deployment to all levels of the organization.
- Supports a strong culture of accountability and inclusion and seeks to develop team capabilities and personal growth.
- Must be able to lift 15 pounds.
- San Diego, CA
- Travel up to 15% may be required.
- Full-time, Exempt
Base Compensation Pay Range: $152,000 - $215,333
In addition to base compensation, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off.
Please Note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience.
We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status, or any other characteristics protected by law.