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Clinical Quality Compliance Lead (GCP)

Genentech


Location:
South San Francisco, California
Date:
01/03/2018
2018-01-032018-02-02
Job Type:
Employee
Categories:
  • Clinical Operations
Genentech
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Job Details

The Position

This position serves as the primary Quality and Compliance Office (QCO) representative and single point of contact for GCP/GVP compliance support for Genentech Early Development (ED) therapeutic area and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies.

 

As an expert, the Clinical Quality Compliance Lead (CQCL) will utilize a risk-based strategy to prioritize QCO support activities for clinical trial activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition the CQCL will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.  

This position serves as an important conduit to the broader organization to ensure a culture of quality and compliance. Incumbent will leverage his/her compliance expertise coupled with a comprehensive understanding of the R&D landscape to proactively contribute to the Genentech Early Development organization. Incumbent will communicate and interface with a host of internal cross-functional partners, both within Genentech and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The CQCL will actively contribute to the development and implementation of Policy/Standard Operating Process / Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within the Genentech Early Development organization. 

The CQCL is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions. 

Key Responsibilities:
  • Provide quality leadership and direction to Genentech ED stakeholders on GCP related activities/issues and act as GCP expert/consultant for QCO colleagues.
  • Act as QCO member of clinical study teams for relevant Therapeutic Areas.
  • Develop strong relationships with ED personnel across functions and teams providing coaching and compliance guidance as needed.
  • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify: priority studies, compliance metrics for tracking, high-risk vendors, and key QCO activities (i.e. protocol review, vendor evaluations, inspection readiness).
  • Identify and escalate significant compliance issues to QCO and relevant leadership, including the assessment of serious breaches.
  • Participate as member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
  • Establish relationship with CRO Quality Team member for the ongoing review of quality and compliance issues.
  • Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
  • Support ED clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
  • Provide support and guidance for ED Quality Management System activities including self-reporting deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation.
  • Present GCP training to ED functions based on identified needs.
  • Facilitate the presentation and interpretation of audit and inspection metrics.
  • Identify and anticipate trends in quality issues and collaborate with department management to ensure risk-managed solutions are implemented in a timely fashion
  • Maintain high level of expertise in international GCP regulations and internal Policies and Procedure that may impact drug development.
  • Promote cross-functional communications and alignment with other GCP/GVP and Healthcare Compliance partners within the organization.
  • Provide regular updates to senior management functions and participate in the resolution of quality issues. 
  • Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or Policy related training (as required)
  • Provide support and guidance during and following internal audits and external regulatory inspections (as required)
  • Support investigations and corrective action plans for appropriate discrepancies as it relates to ED and /or direct the internal investigation of compliance issues as required, collaborating with relevant Compliance Partner(s)
  • 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
  • Supports ED Inspection Readiness program and make recommendations for its continuous improvement
  • Serve as an advisor to management, as needed, and act as an internal/external spokesperson for the organization on matters pertaining to policies, quality plans, objectives and business goals
  • Work collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements. 
  • Lead or participate on quality and compliance initiatives, as assigned

Qualifications

  • Bachelor’s degree in scientific, health sciences or quality related field. 
  • 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.

Skills:

  • 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.

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