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Director, quality risk management

BioPhase

This is a Full-time position in San Diego, CA posted December 14, 2019.

Position Overview We are seeking a Director QA, Risk Management reporting to the VP, Quality Assurance.

This individual will be hands-on subject matter expert and be responsible for having an oversight of the Risk Management Governance process, ensuring compliance with global regulations and standards.

They will also support other departments and project teams as they relate to GxP risk management. ResponsibilitiesProvide Quality leadership and oversight of the GxP Risk Management program.Author/revise Risk Management policies and procedures to align with current business and regulatory requirements.

In addition, create, implement, and manage Quality Metrics Program and Management Review governance policies and procedures.Lead, manage implementation, partner, train and educate on the application of various regulatory and industry risk tools and standards. Create, facilitate and chair standing cross-functional Quality Council Forum where all GxP product and process high risk items are escalated, discussed, mitigated, and documented in accordance to written procedures and standards.Serve as the Subject Matter Expert in Risk Management Governance processes.Working with cross-functional teams, create, maintain and publish a monthly Quality Performance Metrics/Key Performance Indicators including Vendor, Product and Process related trends.Create, implement, and facilitate standing Management Review meetings where Quality KPI’s and other risks are escalated, communicated, and documented.Create and maintain applicable documentation in an accurate and effective manner. Participate in various meetings to provide inputs and help identify risks and escalate to Quality Council Forum for mitigation and documentation.Implement on-going process improvements where identified.ExperienceHands-on involvement and working knowledge in the creation, development, implementation, management industry related risk management tools, quality metrics, and management review guidance documents, and standardsAuthor required foundational governance SOPs, forms, templates, tools in managing risk management program, management of quality council, gathering and reporting integral quality metrics, and holding and facilitating management reviews.Provide ongoing collaboration, engagement, and education to cross-functional teams members in the application and compliance of risk assessment and mitigation processes.Partner with cross-functional colleagues to meet compliance requirements and business needs. Identify and implement continuous improvement projects related to Risk Management, Quality Metrics, and Management Reviews.QualificationsBS degree+ in a technical/science discipline (Chemistry, Biostatistics, Biology) with 10+ years related experience in GxP-regulated biotech/pharmaceutical industries.Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner, both verbal and written.Ability to use critical thinking, resolve issues, and deal with a variety of variables in situations where general standardization does not yet exist.Must possess proficient knowledge of Microsoft Word, Excel, Power Point, Access and other systems such as Smartsheet, SharePoint, etc.