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Associate Director, Quality Assurance Information Systems Management - R&D

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Saturday, March 9, 2024

Job Description

POSITION SUMMARY:

The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software-as-a-Service (SaaS) solutions. This role ensures risk-based, overall integrity of electronic data across all stages of data life cycle and leads development and refinement of quality management systems standards and policies to align with various GxP regulations.

RESPONSIBILITIES:

The responsibilities of this position will include, but are not limited to, the following:

  • Advance deeper understanding of GxP regulations (GxP predicate rules) to ensure appropriate phase-appropriate systems life cycle management and oversight.
  • Define and adopt emerging techniques of software testing and deployment based on standard industry practices and general guidance.
  • Collaborate with Business and Quality Leaders to develop and implement data integrity metrics to ensure effective QMS performance management.
  • Leverage varied and specialized QA technical experience develop and implement effective data integrity governance / controls that improve the impact of the Quality function.
  • Participate in leadership forums such as Quality Leadership Teams to ensure consistent implementation and interpretation of data integrity governance controls.
  • Carry out appropriate analysis based on the risk/issue and take action to mitigate potential risks and deficiencies when making decisions.
  • Participate in/ lead inspection readiness efforts and represent as a subject matter expert during inspections and internal audits events.
  • Align resources and strategies across management structures to successfully lead broad change efforts and ensure meaningful change adoption across areas or functions.

Key Technical Knowledge, Skills and Competencies:

  • Specialized depth of knowledge and demonstrated experience with global regulatory requirements and standards/best practices for computer systems within GxP-regulated environments
  • Demonstrated depth and breadth of global health regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for computer systems quality, data integrity, compliance and systems controls effectiveness
  • Broad and deep quality management, computer systems management, process management, project management and continuous improvement knowledge and experience
  • Influencing/building/promoting a culture of Quality and Excellence
  • Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
  • Skilled at applying risk management principles and processes, managing change
  • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
  • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
  • Must be able to work independently and in a collaborative team setting.
  • Specialized depth of knowledge of health agencies' GxP governing regulations
  • Hands on, extensive experience in implementing electronic records and signatures governing regulations such as FDA's 21 CFR Part11.
  • Familiarity with medical device regulations to appropriately assess and validate embedded med device software applications.
  • Preferred industry standard audit certification.
  • Preferred industry accredited certification of process improvement methodologies such as Six Sigma, Lean Sigma.

Education and Experience:

  • Bachelor's Degree in a scientific or allied health field
  • 8 years of experience or the equivalent combination of education and experience, inclusive of 2 years of supervisory experience leading cross functional teams for large enterprise wide initiatives

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.