Director, Quality

Location
San Diego, CA
Posted
Jul 15, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare.

We are seeking a dynamic, driven, and passionate leader to build and grow a Quality organization in a fast-paced and fun environment. We need an individual comfortable developing an organization and processes to support the unique needs of the genomics industry. We look for flexible candidates eager to build an amazing company and launch amazing products!

Our Director of Quality will establish, direct, and ensure all quality-related functions, including quality engineering, quality systems, quality control, document control, auditing, and supplier management meet global regulations and standards, company policies, and local procedures. Incumbent will establish a new quality system 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.


Responsibilities:

  • Develop quality policies, annual goals, and objectives in alignment with company goals and objectives
  • Develop and implement strategy for quality systems, to include document control, training, internal audits, compliance, complaint investigations, CAPA and continuous improvement
  • Lead multi-site teams to implement the quality strategies with respect to the collection, documentation, analysis, and reporting of quality data to drive preventative and corrective actions
  • 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 review, investigation, and corrective actions of product complaints to ensure consistency and attention to detail in performing and documenting complaint evaluations
  • Ensure investigations are completed in a timely manner to facilitate complaint closure
  • 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 document control activities to ensure all applicable production and quality system documents are controlled and revision histories maintained per procedure
  • 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, and establish quality agreements with critical suppliers
  • Direct the activities associated with transfers to manufacturing of all new products and technology changes and 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 a quality assurance function
  • Prepare appropriate responses and/or corrective actions to notified global bodies and regulatory authorities
  • Other duties as assigned



Requirements:

  • B.S. Engineering, or equivalent field of study, with at least 10 years of relevant experience (an equivalent combination of experience and education may be considered)
  • Ability to understand quality systems and implement systemic changes to enhance product quality and business efficiency
  • Demonstrated ability to make decisions with high integrity with understanding of how to assess and mitigate risk
  • Ability to interpret regulations (QSR, ISO, etc.) into standards and procedures as required with capability to explain these interpretations to all levels of the organization including regulatory bodies
  • Ability to interface with regulatory bodies to defend the company’s state of compliance
  • A self-starter that enjoys a great deal of freedom of action, innovation, and critical analysis as 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 drive is critical to success as quality plan implementation is largely dependent upon ability to recognize the most efficient, cost effective, and strategic approach to attaining the desired goal
  • Understanding of basic applied statistics, statistical sampling plans, statistical process control, and advanced methodologies such as DOE and Taguchi
  • 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
  • Advanced degrees are preferred
  • American Society of Quality (ASQ) certifications (CQE, CQA, CMQ/OE, etc.) are preferred
  • Relevant experience in the life science industry is preferred


We are passionate about our mission to develop high performing products to study genomics in an unprecedented flexibility and to understand biology for the improvement of healthcare. 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 offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives. 

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.