Quality Director A talented and motivated quality professional, with 28+ years experience in the Vaccine/Pharmaceutical industry under cGMP environment. Hands-on Director with proven ability to direct and improve Quality programs, reduce deviations and improve overall compliance and efficiency. ________________________________________KEY STRENGHTS• 28+ years experience in the pharmaceutical industry (vaccines, small molecule - solid and liquid dose mfg, combination products, mAbs) • Strong management and leadership skills in a Quality environment with the ability to mentor staff and develop people (York University - Management Excellence Program, New Directions Consulting Leadership Training)• Superb organizational and communication skills, both verbal and written with the ability to facilitate meetings, conduct training as required and to present information in an advisory capacity to senior leadership, peers and external stakeholders.• Strong interpersonal skills, building relationships, influencing internal and external organizations along with ability to resolve conflicts,• Excellent data analysis skills and ability to provide recommendations that impact the business goals of the company• Critical thinking, problem solving and attention to detail• Ability to manage multiple projects and respect timelines in order to surpass milestones• Inspection readiness, support and responses. • Industry knowledge (cGMPs, ICH Guidelines and Global Regulatory Requirements) for various stages of pharmaceutical development and commercial operations• Extensive quality knowledge including Deviation and Non-conformance (OOS) investigation, CAPA execution, change management• Expertise in Quality Systems (Trackwise, SAP, LabWare LIMS, DMS)
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Chapter Lead External Quality Value DeliveryRoche Nov 2024 - PresentMississauga, Ontario, CanadaWe partner with ONEXQ and PT stakeholders. We enable fast and efficient delivery to patients through the development of flexible, compliant, fit-for-purpose quality system processes and digital solutions across PT.Accountable to:- Partner to develop, implement and support flexible, compliant, fit-for-purpose Quality System , processes and procedures according to Roche PQS- Develop metrics, prepare data and trend analysis and lead MRoQ- Support audits and health authority inspections - Drive quality process improvements and digital solutions
Frequently Asked Questions about Jenn E.
What company does Jenn E. work for?
Jenn E. works for Roche
What is Jenn E.'s role at the current company?
Jenn E.'s current role is Chapter Lead External Quality Value Delivery.
Who are Jenn E.'s colleagues?
Jenn E.'s colleagues are Jasinska Alicja, Ferran Alarcón Heras, Diane Huang, Juan Antonio Salor Delgado, Maximilian Gugel, Danijel Dordevic, Janet And Ray O Kelly.
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