Senior Quality Lead

Employer
Roche
Location
Welwyn
Salary
Competitive
Closing date
1 Oct 2020

View more

Discipline
Clinical Research, Drug Safety
Hours
Full Time
Contract Type
Permanent
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Job Purpose:

The Molecule Strategy Portfolio Lead plays an essential role in
  • Bringing safe medicines to our patients faster by defining, generating and leveraging quality evidence for Molecules, underpinned by an aligned data strategy.
  • Providing Health Authorities with confidence in our data and patient protection that enables a smooth and rapid approval of our medicines. 

The Molecule Strategy team works across the enterprise, on Late Stage Therapeutic Area; in the GCP and GLP Early Development space, and with those Service Providers contributing to Roche Clinical Trials.

Primary Responsibilities and Accountabilities: 
  • Focus on early development projects, both in GCP and GLP.
  • Responsible for the determination of the Quality Positions for the molecule pipeline/ Service Providers supporting clinical trials.
    • Focus on the issues that matter. 
    • Assess the status of Impact Factors, the areas that enable a program to thrive or potentially, could impair/ derail it, namely, for patient/human subject protection. 
    • Deliver the PDQ Strategy in assigned enterprise/therapeutic area through defined QA Positions
    • Develop, maintain and implement a Quality Narrative by synthesizing the results of evidence of quality assurance activities on Roche Quality Positions across high priority molecules in the pipeline.
    • Deliver regular engaging and informative reports on the status and actions of the QA positions for the assigned strategy area to enable company reporting, internal governance committee status updates and health authority engagements
  • Ensure successful Health Authority engagement, including 
    • Sharing of Quality Narratives to Health Authorities
    • Preparing for and managing inspections
    • Hosting and supporting inspections 
    • Ensure appropriate capa is in place
  • Establish strong partnership/relationship with business stakeholders 
    • Seek to understand and evaluate their priorities
    • Actively participate in and make meaningful contributions and propose solutions
    • Consider how best to check-in to stay on top of changes, which then inform your strategy
  • Continuously assess and determine the prioritized PDQ activities 
  • Deliver regular engaging and informative reports on the status and actions of the QA positions for the assigned strategy area (to enable company reporting, internal governance committee status updates and health authority engagements as required for the Global Strategy Head)


  • Education/Qualifications
    • Masters, 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
  • Minimum Requirements
    • Minimum 7 years in pharmaceutical industry and/or quality assurance
    • Minimum 5 years in GCP/GLP related discipline
    • Demonstrated applied knowledge of clinical and regulatory requirements, as well as analytical, organizational and planning skills
  • Desired
    • Proficiency in GLP/GCP regulations
    • Experience supporting regulatory authority inspections
    • Strategic thinking with ability to influence
    • Ability to formulate clear business questions that can be answered with data
    • Proficiency in utilizing data and visualization tools to generate insights
    • Ability to see the big picture while attend to the essential details 
    • Problem solving skills
    • Ability to establish strong collaborative relationships with a broad community of stakeholders across the business
    • Strong verbal and written interpersonal and communication skills.


#LI-PDAB1

Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety

At Roche we believe life is incredibly precious and everyday we strive to solve some of the greatest and most complex health challenges facing humanity.  We help millions of people all over the world live longer and better lives every hour of every day and we’ve been writing scientific history for over 120 years. If you really know yourself and want to be part of our international family, dedicated to making a real impact on the world around us, the next step is yours.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/roche-careers-hub/

Contact Us
  • P.O. Box 8
  • Welwyn Garden City
  • AL7 3AY
  • GB
  • +44 1707 36 6000
  • Mini-site: Roche
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