Roche

Team Lead, Quality Data Operations, PDQ

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
15 Jul 2019
Closes
14 Aug 2019
Ref
201906-118179
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The Team Lead, Quality Data Operations oversees and ensures delivery of PDQ data analytics and is accountable for establishing the end-to-end data management processes and the overall maintenance of associated data lifecycle. The role collaborates closely with relevant internal and external stakeholders to ensure implementation of a holistic, proactive, approach that enables best use of data and data analytics to support PDQ Strategy and thus ensuring that the company is fully compliant with regulatory requirements. It also provides oversight of data collection and generation activities and monitors efficiency of data use across PDQ. The role has accountability for business processes and tools related to all data analytics and data management.   

 

Primary Responsibilities and Accountabilities:
  • Implement a holistic, proactive approach including required data management processes that enables best use of data and delivery of data analytics in support of quality evidence generation activities.
  • Ensure oversight of GCP and Quality analytics (such as quality evidence generation activities and operational metrics) and own associated development process and tools, including relevant platforms and'/or dashboards. 
  • Ensure that quality data lifecycle requirements are coordinated within PDQ and on behalf of other functions. Where necessary work with internal and/or external stakeholders to ensure consistent data collection or output interpretation.
  • Ownership of data lifecycle, including internal and external needs for any PDQ owned/ generated data.
  • Ensuring alignment and consistency of data analytics supporting quality evidence generation activities and relevant process related metrics across Roche pharma development, pRED & gRED. 
  • Provides oversight of data collection/ generation activities
  • Lead and manage members of the quality data operations team to ensure that employees are developed
  • Participates in the extended management team to provide input into the development of strategy, goals and objectives
  • Maintains highest level of awareness, expertise in international GCP, PV regulations and internal policies and SOPs 


Professional and Technical Requirements 

Education/Qualifications: 
  • Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
  • Advanced degree in referenced fields preferred.


Experience:
  • Extensive pharmaceutical industry experience
  • Strong analytics and data management skills with experience in KPI and metrics development
  • Proven experience in setting up and operationalizing data management processes supporting the end-to-end data lifecycle
  • Strong supervisory/management experience
  • Demonstrated knowledge of GCP, GLP, CSV, pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills.

 

Desired:
  • Data analytics background with technical ability to understand advanced concepts of data science


Experience, Skills, Knowledge:
  • People management/People motivation
  • Strong analytical skills, including understanding of generation of insights from data
  • Demonstrated ability to effectively communicate, influence and lead both with and without authority.
  • Highly effective teamwork and collaboration skills. 
  • Proven demonstration of leadership, strategic and system thinking. 
  • Ability to work effectively in an international multicultural matrix organization. 
  • Effective communication, change management and customer management skills. 
  • Fluency in written and spoken English. 
  • Demonstrated knowledge of product development related global regulatory requirements. 

Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance

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