Director of Quality Systems Compliance

Boston, MA Boston, United States


Description

Do you have a passion for quality management, technology and science; including standards such as GxP?  Are you looking to work at a fast-paced growth stage technology company? Are you interested in working in the cutting edge field of genomic precision medicine?  Do you have an attention to detail, strong writing, speaking, and customer engagement skills? If yes, we have an exciting leadership position available at Seven Bridges. 

The Director of Quality Systems Compliance will lead Seven Bridges quality program as a member of the information security and compliance leadership team, reporting to the Chief Information Security Officer.  The successful candidate will be engaged with both internal Seven Bridges stakeholders and external customer quality teams. The role requires the ability to influence internal stakeholders in maturing quality systems compliance which will include policies, procedures, software development lifecycle (SDLC) validation, training, quality and pharmaceutical  specific compliance (GxP, 21 CFR Part 11, CLIA, ISO 13485, etc). External customer engagement will be required for this role which includes customer quality audits. 

Responsibilities

  • Ensure that Seven Bridges’ clients can comply with GxP, 21 CFR Part 11, and EU Annex 11 requirements applicable to the work they conduct with Seven Bridges
  • Ensure our SDLC and software validation processes meet GxP requirements, comply with the FDA’s guidance on Software Validation, and meet GAMP 5 standards
  • Develop documentation, standard operating procedures (SOPs), and training programs which meet GxP requirements
  • Achieve ISO 13485 certification for the quality systems supporting the Seven Bridges Platform
  • Develop the company’s quality training process and, in conjunction with People Operations, oversee its operation and ensure it meets applicable quality requirements
  • Ensure our SDLC and software validation processes and documentation meet applicable quality requirements
  • Develop and maintain documentation and record-keeping processes to meet quality requirements, including Validation Plans, Requirements Trace Matrices, User Requirements Specifications, Design Specifications, etc.
  • Develop quality incident response and corrective action preventive action (CAPA) processes and ensure they meet applicable quality requirements
  • Ensure vendor management practices meet applicable quality requirements
  • Serve as the point person for audits of our quality systems by clients, certification firms, and regulatory agencies
  • Serve as a subject-matter expert on GxP, 21 CFR Part 11, and software validation for internal and external stakeholders
  • Must be able to establish strong working relationships with stakeholders (Engineering, Scientific Operations, Product, Sales, etc) to ensure successful achievement of quality objectives
  • Start as an individual contributor, with plans to build a team
  • Travel 10%, including Belgrade, Serbia office location

Qualifications

  • Bachelor’s degree in Computer Science, Quality Management, Business, Science or related fields or an additional 3 years’ experience required
  • 6+ years experience in clinical software validation required 
  • Expertise in GxP and 21 CFR Part 11 required
  • Experience developing and rapidly improving quality documentation and training processes required
  • Experience working with software validation for Platform-as-a-Service or Software-as-a-Service products preferred
  • Experience serving as the point person for regulatory inspections or ISO 13485 audits preferred
  • Familiarity with Annex 11, GAMP 5, and ISO 13485 preferred
  • FDA Computer Systems Validation (CSV) training preferred
  • Quality software related certifications; Certified Software Tester (CSTE), Certified Associate in Software Quality (CASQ), preferred
  • Organized, detail-oriented, trustworthy, willing to speak up, proactive, persuasive

Technology

  • Amazon Web Services (AWS) and Google Cloud Platform (GCP)
  • Atlassian Suite - JIRA & Confluence
  • G-Suite business applications (docs, sheets, slides, etc)

Extra Credit

  • Master’s degree or Doctorate in technology, science or quality management.
  • CISSP, CISM, CISA, ISO 27001 Lead Auditor, or other security certifications 
  • Experience with ISO 27001, 27017, 27018, 27701, NIST 800-53, SOC 2
  • Docker, Linux, Ansible
  • A sense of humor

Did you ever dream of working in a Candy Factory as a kid?  It’s not too late! Seven Bridges is located in Charlestown Massachusetts, at Schraff’s City Center, formerly a candy factory.  And what could be sweeter than working at a company on the cutting edge of genomic science and cloud technology to enable the development of precision medicine to treat disease.