Quality System Manager

Location
Menlo Park, CA
Posted
Oct 07, 2021
Ref
1779655
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

 

JOIN US!
Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.

 

QUALITY SYSTEM MANAGER

 

Overview:
The Quality System manager is responsible for the overall management of the electronic Quality Management System (eQMS) as it relates to the configuration, implementation, analysis as well as the on-going maintenance of the eQMS across multiple Quality System modules to maintain compliance with FDA and all other U.S. and International Regulatory requirements plus drive continuous improvement of the management system. 

 

Key Responsibilities:

  • Responsible for maintaining the eQMS system and performing tasks related to the on-going use and continuous improvement of this eQMS to support cell therapy drug development.
  • Develop and execute the eQMS installation, operation and performance qualification (IOPQ) of each separate Quality System module (e.g. Non-Conformance/Deviation, Audit, Change Control, CAPA, Equipment Management, Vendor Management, etc.).
  • Provide sitewide training on the eQMS and additional modules implemented on an on-going basis.
  • Following up on support issues proactively to provide timely updates and resolutions to end users.
  • Provide troubleshooting expertise to end users on an ad hoc basis, consulting with the software vendor(s) as needed.
  • Work with vendor(s) to troubleshoot and resolve application issues.
  • Coordinate and communicate with impacted stakeholders as needed.
  • Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate Computer System Validation (CSV) procedures and requirements.
  • Develop and review protocols, plans, test scripts, reports, procedures, Work Instructions, etc. associated with the implementation and maintenance of the eQMS.
  • Provide QA oversight during risk assessment(s), Part 11 and Annex 11 and regulatory assessments of eQMS modules.
  • Represent the eQMS group at cross-functional meetings.
  • Review changes to validated state of eQMS through the Computer Change Control process.
  • Participate in planning and implementing changes.
  • Serve as the QA contributor on projects including inquires pertaining to the interpretation of the FDA and other regulatory requirements for computer system validation.
  • Perform other quality and computer system validation duties as assigned.
  • Stakeholder in the development, implementation and continued improvement of the quality sub-systems within the QA department.
  • Member of a team responsible for coordinating and executing all activities necessary to maintain compliance with cGMP and the integrity of the eQMS.
  • Execute document and change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
  • Assists in the development and maintenance of training content, training curricula and metrics in compliance with policies, procedures, and applicable regulations.

 

Desired Qualifications:

  • BS degree in a scientific discipline.
  • 5+ yrs Quality Systems experience in a regulated GMP environment at an operational level supporting manufacturing and  testing in small or large biotech/pharmaceutical environments.
  • 4+ yrs experience in establishing & managing an electronic QMS.
  • 3+ yrs experience supervising direct reports.
  • A broad-based technical knowledge and skills in business areas such as Quality Assurance, Quality Systems, Regulatory and Quality Compliance pertaining to computerized system validation and qualification activities.
  • Thorough understanding of Data Integrity concepts and controls for computerized systems.
  • Exercises judgement within well-defined and established processes and practices to determine appropriate action.
  • Ability to work independently in addition to ensuring work product deliverables are consistently being met.
  • Experience in Quality Assurance, Document Control, Training, Non-Conformance/Deviations, CAPA, Change Control, Audits (Internal/External), Vendor Management and Equipment Management Systems.
  • Strong skills with Microsoft Word, Excel & PowerPoint.
  • Strong interpersonal, collaboration and influencing skills with team building and development capabilities.
  • A demonstrated record of overcoming resistance to change and driving the adoption of new business processes from a position of direct and indirect/informal authority.
  • Excellent relationship building and persuasion skills with the ability to motivate and influence others.
  • Knowledge of the US FDA Quality System regulations.
  • Knowledge of GDP, GMP, GCP, ICH, GAMP-5 and CFR requirements and regulations.
  • Comfortable working in startup environment and communicating cross­ functionally across site.
  • Excellent verbal and written skills to successfully communicate clearly and in an engaging manner with colleagues of various levels of experience and management while counseling, negotiating and formally presenting views and/or technical criteria clear and assertively.

 

Benefits:
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.