Principal Quality & Compliance Leader

The Position
The Principal Clinical Quality Compliance Leader (CQCL) is an influential leader who demonstrates strategic agility and applies expertise while promoting quality and compliance principles through partnership and collaboration with Genentech Early Clinical Development's (gRED) Early Clinical Development (ECD) study teams. The CQCL will interface and collaborate with key internal Genentech/Roche cross functional stakeholders, as well as external vendor/CRO stakeholders. The CQCL serves to build a culture of quality and compliance, identifies areas for improvement while applying technical expertise to assess compliance with current regulatory policy, regulations, guidance's and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies.
Job Responsibilities

• Develops partnerships with key enterprise business partners and stakeholders such as ECD Clinical Operations and Clinical Science, Safety Science, and Service Vendor Solutions Product Development Quality (PDQ), and other Roche stakeholders to advance compliance solutions and enable transparency, escalation, and resolution of quality and compliance matters.
• Fosters an open and collaborative environment within ECD and across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH).
• Understands the GNE and Roche organization, particularly ECD and PD organizational dynamics.
• Builds, collaborates and manages key relationships within ECD and various enterprise organizations (PDS, PDR, PDQ, PDG, pRED, USMA, etc.) to better support and understand the compliance-related needs of the business and drive the strategic direction for compliance activities within ECD.
• Operates as a trusted partner to study teams and ECD, GNE, and Roche stakeholders.
• Provides quality guidance, leadership, direction and to GNE ECD Stakeholders for the conduct of gRED Early Clinical Development (ECD) study programs and establishes measures to reduce compliance risks and enhance successful clinical trial conduct.
• Identifies and anticipates potential problems impacting the ability to meet business goals; develops and implements methods of improvement and resolution
• Independently leads and/or participates, in intradepartmental, global and cross-functional initiatives, working groups and project teams as a decision maker or as a lead reviewer of initiatives and solutions with greater complexity and broader organizational impact.
• Serves as a consultant to management and acts as spokesperson for ECD on matters pertaining to policies, objectives and business goals. Provides updates to QCOLT as necessary.
• Acts as key strategic expert interfacing with internal and external stakeholders for early landscaping, planning, execution and delivery of ECD quality management-related projects while proactively communicating status, issues, and proposed solutions to the QCO/ECDLT
• Works collaboratively with internal and external business partners and key stakeholders to provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
• Maintains the highest level of expertise in GCP guidance's and regulations, industry best practices, and internal policies and procedures impacting drug development to promote quality and compliance within ECD. Embeds quality principles throughout the organization.
• Effectively integrates compliance risk/context and business knowledge to address significantly complex problems in the areas of GCP guidance's and regulations, privacy, company policy & procedure
• Creates and delivers effective communications to promote compliance awareness, policy/process changes, and business goals within the gRED organization
• Identifies and escalates significant compliance issues and potential Serious GCP Non-Compliances within QCO and to relevant leadership
• Leads the Quality-to-Quality governance relationship with the alliance CRO Quality Assurance representative for the ongoing assessment, review, and mitigation of quality and compliance issues on gRED programs
• Collaborates with ECD stakeholders in the conduct of Quality Assessment Activities (QAA) at the investigational site or through internal desktop assessments (Potential travel 10%)
• Provides leadership and support to the One Roche CRO Quality Governance through consultative guidance on the development of the key defining principles and documents
• Identifies trends in quality events and collaborates with leadership and stakeholders to ensure risk-based solutions are implemented in a timely manner.
• Supports ECD clinical team/functions through guidance in drafting responses and corrective action/preventative action plans (CAPAs) to internal/external audits, quality events, site non-compliance and external inspections (as required). Provides strategy, support and guidance.
• Identifies potential compliance matters and drives the development and implementation of methods for improvement and resolution in a pragmatic and effective manner. Supports QMS activities including self-reporting of deviations, root cause analysis and CAPA plan development and evaluation
• Proactively researches, evaluates and makes recommendations associated with evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices as it relates to drug development.
• May act as Global Process Owner (GPO) to be accountable for the design, maintenance, continuous improvement and oversight of the effectiveness and compliance of individual, global end to end processes. Represents Roche/GNE as the end-to-end expert for designated SOPs during Health Authority Inspections and internal audits.
• Partners with QCOLT to optimize and continually improve department processes, maintain role definitions and standards, and develop role-based competency and training programs for staff.
• Supports inspection preparation and management for local country and global Health Authority inspections. Activities include inspection preparedness training of relevant staff, the preparation, review and provision of relevant inspection materials, guidance and support for inspection responses and remediations.
• Performs any other tasks as requested by management to support quality oversight activities.
• Develop and deliver compliance training to ECD functions based upon identified needs.
• May perform the following managerial responsibilities: identify, recruit, hire, onboard and manage a team of direct reports.
  
  • Provide team leadership (oversight, guidance and subject matter expertise) and responsible for the strategic direction to meet organizational objectives.
  • Oversee the work of direct reports to ensure on-time, on-target and within-budget results. Provide ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources.
  • Conduct regular one-one-one and any other staff meetings to ensure timely communication with direct reports. Provide formal performance reviews and career development planning for all direct reports.

Job Requirements
Education and Experience:

• Bachelor's degree required (life science or other relevant healthcare discipline is preferred).
• Minimum of 12 - 15 Years; 10 - 13 Years with Masters; 7 - 10 Years with PhD/JD; 3 - 5 Years with MD experience in pharmaceutical drug development, preferably in regulatory compliance and/or quality responsibilities within a drug development organization.
• Minimum of 8 years in GCP-related discipline/quality assurance role.
• Working knowledge of systems development lifecycle methodologies (SDLC), preferred
• Preferably in depth familiarity with GxP regulations/guidance and CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity
• Impeccable ethics, exercises sound judgement and discretion in matters of significance.
• Demonstrated experience with strategic planning, prioritizing, and management of high level initiatives and projects.
• Strong organizational and prioritization skills, including the ability to manage multiple projects of different levels of complexity.
• Knowledgeable in stakeholder management and influencing change. Proven interpersonal skills, customer focused approach and effective teamwork and collaboration skills.
• Must demonstrate knowledge of and strong aptitude to learn about the evolving the legal and regulatory environment GCP/ICH guidance's, standards and applicable laws as it relates to a global pharmaceutical organization.
• Excellent organizational and planning skills, works without direction to prioritize, identify conflicts and meet deadlines.
• Strong verbal and written communication skills.
• Highly adept at synthesizing and summarizing unusually complex and/or voluminous content is not clear, concise, and actional communications. Leverages these skills to work effectively and credibly with leaders across ECD.
• Work performed without direction. Exercises significant latitude in determining objectives and approaches to assignments and assignments of direct reports/team
• Proven ability to lead the analysis and simplification of complex systems or processes into pragmatic solutions. Strong ability to analyze and simplify complex systems.
• Highly Effective in analytical and strategic assessment of GCP and Privacy compliance risks and the ability to articulate potential business impact.
• Demonstrated ability to influence and lead both with and without authority in a matrix organization, leading innovation and change
• Expertise in use of Microsoft and Google Suite.

Work Environment/Physical Demands/Safety Considerations

• The ability to work more than 8 hours or 40 hours in a given week as needed by business demands
• The ability to participate in early morning or late-night zoom call, phone, calls, or Google Hangouts
• The ability to travel domestically or internationally as needed by business demands

The expected salary range for this position based on the primary location of South San Francisco, CA is $160,200-$297,600. 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.
Benefits
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.
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