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Quality Director

Cambridge, MA · Science/Research
About Vizgen:

Vizgen is a rapidly growing company developing the next generation of spatially resolved genomic profiling tools that enable researchers to gain new insight into the biological systems that underlie human health and disease. The company's groundbreaking MERFISH spatial transcriptomics technology images RNA molecules with high accuracy and unrivaled detection efficiency at subcellular resolution. MERFISH provides transformative insight into a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, and regenerative medicine. For more information, go to www.vizgen.com
 

Position Summary:

Vizgen is seeking a Quality Director who will be responsible for all aspects of establishing, implementing, and maintaining the Vizgen Quality system. The ideal candidate will provide technical, managerial, operational, and strategic leadership in the development, implementation, and innovation of a compliant Quality Assurance function. This individual will establish and manage the Quality function necessary to successfully design, develop, manufacture, and commercialize Vizgen’s product portfolio of instruments, reagents, and software. This position will oversee the setting of policies and specifications, the product development process, product testing requirements, facility testing and establishing phase appropriate critical quality attributes. This role will work closely with the leadership team and collaborate close with R&D, Operations, and Technical Support. 

Key areas of responsibility:

  • Assures quality products and processes by establishing and enforcing quality standards and testing materials and products
  • Develops standards and criteria for adhering to the product development process
  • Establishes quality and reliability standards by studying product and user requirements with other members of management and with production operators, technicians, and engineers.
  • Establish and manage a quality management system for recording and documenting policies and procedures
  • Develops standards and systems for qualifying suppliers and vendors and negotiating quality agreements with key suppliers.
  • Implements in-process product inspection standards manufacturing methods and devising testing methods and procedures.
  • Ensures compliance with state, federal, and international quality and regulatory guidelines and requirements and industry standards
  • Implement and manage a complaint and CAPA tracking system for tracking and resolving quality issues
  • Maintains product quality by enforcing quality assurance policies and procedures and government requirements.
  • Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods.
  • Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
  • Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results.
  • Trains employees and staff on the quality system and roles and responsibilities
  • Lead, manage and develop people ensuring that the Quality team and individuals have the necessary skills, knowledge, experience and motivation to perform their roles
  • Work closely with leadership team to align on strategies and objectives for achieving industry leading product quality 

Qualifications:

  • BSc, MSc, degree or above in life sciences, engineering, or Quality Management related fields
  • 10+ years work experience in Quality Management in a life sciences manufacturing company
  • 5+ years managing a Quality team desired
  • ​Extensive knowledge of regulatory and quality standards including ISO 9001, ISO 13485, cGMP, GDPR and other relevant guidelines including those related to software
  • Experience with products ranging from reagents, plastic consumables, instruments, and software 
  • Experience in managing audits and on-site inspections from external agencies 
  • Substantial background in managing complex projects/teams within corporate objectives and project timelines and a strong understanding of underlying business drivers. Skilled at applying project management processes and tools to lead meetings, assist with project planning, and facilitate attainment of project objectives.
  • Demonstrated history developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
  • Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
  • Open, available, and transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
  • Experience in managing relationships with internal departments, external vendors, and partners in a collaborative, constructive manner
  • Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively
This position may be subject to pre-employment checks, including driving history check, drug screening and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable federal, state, and local laws.

We offer a competitive salary, meaningful stock ownership, 401K, health benefits, a great work environment and the opportunity to enter a high-growth startup company. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of tackling challenging technical problems.


WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Vizgen affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.

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