The PDQ 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. This role requires expert level GCP knowledge and will be accountable for the quality assurance aspects focusing on Service Providers and Suppliers. 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 hosting and management of major regulatory authority inspections.

Responsibilities and Accountabilities:

• 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.

• Issue Management: With a core focus on Service Providers (Vendors), (and Suppliers as applicable/secondary focus) independently manage 'for cause,' critical, and/or complex significant quality issues, group individual findings into systematic issues for process improvement, and escalate significant issues to PDQ management.

• 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.

• 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 or play a key role in inspection preparation and management of Health Authority inspections, including hosting, providing inspection training to staff and presenting Quality Strategies and conclusions with a specific focus on Service Providers.

• 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:

• Bachelors 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 and/or Medical Device 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 to effectively organize and execute tasks

Preferred:

• High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GxP/CSV areas; Experience hosting, managing and supporting regulatory authority inspections; Strong digital and data literacy

• Ability to formulate clear business questions that can be answered with data and in utilizing data and visualisation tools to generate insights

• Proven ability to influence and negotiate effective solutions within PDQ, PD, and/or industry through leading change and driving for results; Strong understanding of PDQ business and functional group operations; Proven ability to assimilate new and emerging compliance information or trends and translate into impact for PDQ

• Proven record of working in a global, multicultural matrixed organization (multi-lingual skills desirable)

• Demonstrated excellent analytical, strategic- thinking, and problem-solving skills with a proven ability to understand business impact

This role is based at our South San Francisco, CA campus/Mississauga or Basel headquarter sites.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $158,200 - 293,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.