Principal Quality Lead

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche!

The PDQ Principal Quality Lead supports the Roche/Genentech Organization through the development and delivery of Quality strategies, audits and conclusions for entities (e.g. molecules in development, post approval products, affiliates, processes) based on a risk-based approach. Quality strategies are based on the Critical to Quality framework which encompass Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Personalised Healthcare (PHC) and Computer Systems (CS) requirements.

The Quality Lead will generate Quality strategies, evidence and actionable data through the conduct of audits and other quality activities to assess the Quality status and be able to support the demonstration of effective implementation of Quality Assurance to stakeholders and Health Authorities.

The Principal Quality Lead is a highly experienced Quality Professional who will be able to lead the design of complex Quality Strategies and conclusions in multiple areas (e.g. Multiple GxPs), solve for unique or unprecedented problems, leading large/global cross-functional projects. In addition, the Principal Quality Lead will lead and directly influence the delivery of PDQ work, development of PDQ processes and procedures, participate in PDQ goals and initiatives, and management of regulatory authority inspections.

• Design and Implement Quality Strategies:
  Establish strong partnerships with business stakeholders and independently define the Quality Assurance approach, assessing specific risk areas and proposing strategy modifications.
• Define Audits and Methodology:
  Define the audits required to deliver the Quality Assurance strategy and lead the development of methodology, including the use of data analytics.
• Perform and Lead Audits:
  Independently perform and lead audits, managing preparation, conduct, presentation, timely reporting of outcomes, and evaluation of actions taken.
• Issue Management:
  Independently manage 'for cause,' critical, and/or complex quality issues, group individual findings into systematic issues for process improvement, and elevate significant issues to PDQ management.
• Quality Conclusion Drawing:
  Independently draw conclusions on the Quality Positions and ensure appropriate action plans are developed to determine acceptability of evidence of compliance.
• Stakeholder Communication:
  Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs regarding compliance issues.
• Health Authority Inspections:
  Lead inspection preparation and management of Health Authority inspections, including providing inspection training to staff and presenting Quality Strategies and conclusions.
• PDQ Goals and Initiatives:
  Contribute to the long-term strategic direction of PDQ, lead departmental or cross-functional compliance projects, and lead the development/revision of PDQ processes and procedures (SOPs, Work Instructions).
• Expertise and Mentorship:
  Maintain expert knowledge of GxP regulations, company policies, and SOPs, assess the impact of new regulations, and act as a trainer and mentor for International and Senior Quality Leads.

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
• Minimum 10 years in pharmaceutical industry and/or nonclinical/clinical research/PV experience
• Minimum 8 years in GCP/PV/CS related discipline / Quality Assurance role (auditing)
• Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills
• Project management experience with proven leadership, mentoring and coaching;
  Demonstrated ability…