Quality Director
Company: Vizgen
Location: Somerville
Posted on: June 17, 2022
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Job Description:
Vizgen, Inc. - Cambridge, MAVizgen 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.comPosition 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 productsDevelops standards and
criteria for adhering to the product development processEstablishes
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 proceduresDevelops 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 standardsImplement and manage a complaint and CAPA
tracking system for tracking and resolving quality issuesMaintains
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 responsibilitiesLead, manage and develop people
ensuring that the Quality team and individuals have the necessary
skills, knowledge, experience and motivation to perform their
rolesWork closely with leadership team to align on strategies and
objectives for achieving industry leading product
qualityQualifications:BSc, MSc, degree or above in life sciences,
engineering, or Quality Management related fields10+ years work
experience in Quality Management in a life sciences manufacturing
company5+ 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 softwareExperience 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
objectivesExperienced, self-motivated individual who can handle
multiple priorities to meet project team goals and timelinesOpen,
available, and transparent communicator with strong leadership,
presentation and influencing skills, and problem-solving
abilityExperience in managing relationships with internal
departments, external vendors, and partners in a collaborative,
constructive mannerExcellent written and verbal skills and the
ability to communicate clearly, concisely, and effectivelyIf you
aren't sure you meet every requirement but are excited about what
you read here, please consider applying! We believe diversity
drives innovation. Above all, we're looking for the right person
with skills and talent to grow the company together all while
enriching your professional and scientific experience.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.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 ARE AN EQUAL
OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYERVizgen 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.
Keywords: Vizgen, Somerville , Quality Director, Executive , Somerville, Massachusetts
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