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Job Location: San Francisco, CA
The Position
Sr Director, Director, Compliance & Data Integrity, Small Molecule Pharmaceutical Sciences
Responsibilities include:
- Represent SMPS at Genentech/Roche Local and Global Quality & Compliance Management meetings/forums
- Assess compliance risks within SMPS using risk-based approaches, and provide guidance to operational leaders for remediation (including tracking for completeness and effectiveness)
- Ensure phase appropriate, small/synthetic molecule specific quality requirements are appropriately defined within SOPs and Best Practice Guidance documents
- Lead audit planning and assist Quality Assurance and Technical Functions with audit management, response strategy and remediation activities. Use risk based approaches to help identify recommended focus areas for audits and self-inspections.
- Provide data system guidance and support for applicable elements of the quality system, e.g. Computer System Validation, Data Integrity, Data Lifecycle Management, etc.
- Hiring & managing consultants and/or contractors to support responsibilities as needed
Who You Are:
Successful candidates with possess the following qualifications
- Bachelor’s degree in relevant scientific discipline (Chemistry, Pharmaceutical Science, Biochemistry, Engineering, Regulatory Science). Masters/PhD preferred
- 15+ years pharmaceutical development, including recent experience directly supporting GMP activities in a Technical, Quality Assurance, or Compliance role. Experience supporting early clinical development preferred
- Passionate about simplification, continuous improvement, and action orientated
- Demonstrated knowledge and utilization of quality risk management tools/approaches
- Ability to understand details, identify area of improvement, drive changes to quality management systems
- Demonstrated ability to partner with Quality Assurance, Regulatory Affairs, and other technical functions
- Strong communication skills
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.
Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
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