At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
We are looking for an International or Senior Quality Lead (located in San Francisco or Mississauga) to join our Quality Assurance Programs team!
PDQ Vision:
In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes and unrivaled transparency with health authorities, patients and society. Our work provides quality leadership, know-how and partnering across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
The Opportunity:
The PDQ International or Senior Quality Lead drives Roche/Genentech product development through:
Design and Implementation of Quality Assurance molecule (GCP) strategies
Establish relationships with business stakeholders
Contribute to the assessment of specific Critical to Quality (CTQ) risk areas on an ongoing basis
Contribute to development of methodology including the use of data analytics and maintain related tools/procedures.
Delivery of activities to assess Molecule Critical to Quality (CTQ) Conclusions
Perform and lead audits, including preparation, conduct, presentation and timely reporting of outcomes, and evaluation of actions taken
Identify systematic issues and areas of opportunity for escalation to governance bodies.
Ensure appropriate action plans have been developed and determine acceptability of evidence of compliance per the Clinical and Safety Finding Management (CSFM) process
Leadership in 'for cause', critical, and/or complex quality issues
Deliver leadership to inspection readiness and inspection management activities to demonstrate quality confidence in key programs.
Manage all aspects of inspection readiness and represent the organization during major health authority inspections (e.g., FDA, EMA, PMDA, MFDS, Health Canada).
Plan, facilitate, and lead mock inspections, pre-inspection site visits, and inspection-related training sessions.
Collaborate with cross-functional teams to align on inspection readiness strategies, storyboards, and risk mitigation plans.
May serve as the front or back room lead during inspections, managing inspection requests and guiding subject matter experts.
Who you are:
Experience, Skills, Knowledge
Experience and competency in conducting several audit types and leading at least one audit type within GCP and/or Medical Device.
Knowledge of drug development processes and GxP/CS regulations
Experience with major Health Authority Inspections (FDA, EMA, Health Canada)
Ability to influence with and without authority, and negotiate effective solutions
Demonstrated ability to work both independently and in a team environment
Demonstrated analytical, problem- solving and decision-making skills
Strong verbal and written communication and customer management skills
Demonstrated ability to effectively organize and execute tasks
Education and Experience Requirements:
Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education,training and experience
Minimum 5 years in pharmaceutical industry and/or industry and/or nonclinical/clinical research
Minimum 2 years in GCP/CS/Device Quality Assurance role (auditing)
Key Competencies
Ability to use and analyse data
Collaboration and teamwork
Managing projects
Communicating and presenting
Driving for solutions
Relocation benefits are not available for this position.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.