Genentech Clinical Quality Compliance Lead in South San Francisco, California
Clinical Quality Compliance Lead
South San Francisco
California, United States of America
Job ID: 201905-115125
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This position reports into the Head of CQC and is primarily responsible for ensuring a robust ECDQMS is in place and serves as the core Quality and Compliance Office (QCO) representative for Global QMS and Medical Compliance Risk activities in Genentech ECD.
Partnering with Clinical Quality Compliance (CQC) and Governance, Standards and Continuous Improvement (GSCI) staff in the ECD Quality Compliance Office, the CQML will provide sound judgment and risk-based rationale to help enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.
Incumbent will communicate and interface with a host of internal cross-functional partners, both within the QCO, Genentech and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.
The position also provides management, coaching and development of direct reports and/or junior employees and identifies and implements areas of best practice and process improvements and risk mitigation strategies within the group and the broader organization as appropriate/assigned.
The CQML is expected to foster an open and collaborative environment across the global site network and will help ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions
Acts as key strategic expert interfacing with internal and external stakeholders for early landscaping, planning, execution and delivery of the ECD Quality Management related projects while proactively communicating status, issues and proposed solutions.
Oversee maintenance of ECD QMS systems and activities, including annual Quality Plan, ECD Quality Handbook and management of ECD Corrective and Preventative Action Plans (CAPAs).
Lead the ECD implementation of the Roche Medical Compliance Risk Assessment strategy including collaboration with QCO staff, other Roche global functions, annual risk assessment, communication to ECD leadership and tracking mitigation strategies and outcomes.
Function as Quality Risk Management program lead for ECD responsible for working with respective Business Process owners to define the risks of each of their respective quality systems and the overall “state” of control and/or health of that quality system.
Serve as an advisor to management, as needed, and act as an internal/external spokesperson internal/external spokesperson for the organization on matters pertaining to the Roche Global Quality Policy and Quality Plan objectives.
Lead the development and trending of metrics programs within QCO for quality related activities, assessing functional areas for trends and opportunities for improvement.
Drive the execution of GCP compliance or quality related initiatives that have a cross-functional impact ECD impact or as it relates to a critical global compliance issue.
Ensure timely closure of ECD CAPA’s, resolve any conflicts to closure and align efforts with applicable Quality and Compliance organizations (including QCO staff), to ensure that systemic findings and/or trends are incorporated are mitigated.
Evaluate relevant metrics, proactively assess potential risks and recommend mitigating / remediating actions in collaboration with Heads of CQC and GSCI to ensure that issues/risks/trends are appropriately escalated & communicated to business partners.
Partner with other Roche Global Quality and Compliance functions and roles to promote adherence to regulations, Policies, SOPs, and guidelines.
Identify and anticipate trends in quality issues and collaborate with QCO Leadership to ensure risk-managed solutions are implemented in a timely fashion.
Partner with GSCI Staff or QCO Staff to identify processes and procedures to be developed and owned by Quality and Compliance Office and provide support to functional process owners on process improvements, metrics and standards
Provide support and guidance for ECD Quality Management System activities including self-reporting deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation.
Present QMS, Root Cause Analysis (RCA), CAPA and Risk Management training to ECD functions based on identified needs.
Support cross-functional communications and alignment with other GCP/GVP and Healthcare Compliance partners within the organization.
Provide regular QMS updates to the ECD Leadership Team, functional leadership and QCO providing trend analysis and recommendations for improvement.
Provide support and guidance during and following internal audits and external regulatory inspections (as required)
Lead or participate on quality and compliance initiatives, as assigned.
Maintain high level of expertise in international GCP regulations and internal Policies and Procedure that may impact drug development.
Degree in scientific, health sciences or quality related field.
Experience 12 – 15 Years, Bachelors, 10 - 13 Years with Masters, 7 - 10 Years with PhD/JD.
Minimum of 12-15 years with in a pharmaceutical drug development GCP related discipline.
Previous experience managing quality and GCP compliance issues.
Experience with cross-functional stakeholder management.
Expert knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA), Japan (PMDA), and ICH Guidelines.
Demonstrated knowledge of ICH/GCP, healthcare laws, regulations and standards as they pertain to systems/procedures adopted within, and/or related to, Genentech Early Clinical Development in the conduct of their business.
Expert knowledge of the drug development processes.
Demonstrated strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines.
Ability to influence people at different levels and negotiate cross functionally in matrix organization to resolve conflicts.
Ability to build and sustain meaningful relationships with business stakeholders and partners.
Pro-active, solution-oriented mindset and sound judgement for evaluation of risks, guidance and escalations
Strong project management skills including team leadership, consultative facilitation, risk analysis, and project planning.
Highly self-motivated, well organized, confident, possessing a solution-oriented mindset and able to develop innovative solutions to issues.
Strong computer literacy in MS Word, Excel, Project, Visio and PowerPoint.
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.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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