Associate Director, Information Systems Management (Hybrid)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- 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.
- Partnering with stakeholders to advance process simplification, data quality enhancement and automation within the GMP Lab / Manufacturing Area.
- 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.
- 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.
- Preferred industry accredited certification of process improvement methodologies such as Six Sigma, Lean Sigma.
- 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