consulting on QA activities within the Pharmaceutical and Biotechnology industries

TESARO is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. • Perform batch release through batch record and data review/approval and managing process deviations for timely release• Develop in-process and release specifications• Operate the systems for deviations, CAPAs, change control in an efficient manner for adequate and timely closeout of these events• Maintain the vendor qualification program through timely audits and follow-up actions• Schedule, perform and manage GxP audits• Evaluate, approve and track manufacturing deviations, CAPAs and change control• Write SOPs to further develop the Quality System and control over the quality of vendor services and products • Assist in the building and management of the documentation system• Assist in the development of Quality metrics• Train appropriate personnel on quality procedures• Assist in the QC review of various documents, including regulatory dossiers and reports • Assist in the planning of budgets• As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues• Clearly communicate issues to vendors and Tesaro management in a timely basis• Regularly meet with the Senior Director of QA to update activities, resolve issues, maintain time lines and plan in order to meet the company’s goals• Understands applicable FDA and EMEA regulatory regulations and guidelines related to bio-pharmaceutical manufacturing/drug product development.• Supports the preparation, coordination, and management of regulatory agency Preapproval inspections.• Provides Quality Assurance leadership, guidance, and direction to CMOs consistent with cGMPs and TESARO quality compliance.

Responsible for the management and coordination of activities required to meet quality standards. Act with other managers and staff throughout the organization to ensure that the QA system is functioning properly. Advise on changes and their implementation and provide training, tools and techniques to enable others within the organization to achieve the highest quality standards. Achieve excellence in customer satisfaction, process and product quality and reliability.

Managed Quality Assurance activities for novel, small molecule based oral and parenteral drugs at manufacturing partner sites for clinical oncology, neurology and cardiovascular projects• Point person for time critical authoring and reviewing regulatory submissions, including INDs, IMPDs and annual reports • Composed and coordinated approval of specifications for API and Drug Products for inclusion in regulatory filings• Reviewed and approved validation of analytical, process and cleaning activities in support of regulatory submissions• Released clinical trial materials for Phase I through Phase III projects

Directed Quality Assurance and Validation activities for production of clinical trial materials for protein based oral and parenteral drugs at several contract manufacturing sites.

Managed Quality Assurance activities for pharmaceuticals utilizing nanocrystaline silver particles.

Provided Quality Assurance activities for Enbrel Refacto, BeneFIX and other commercial pharmaceutical products distributed within the US, European Union, Japan and ROW. • Released Enbrel for packaging and distribution for EU, Japan and ROW.• Performed a 6 month ex-pat assignment at Wyeth’s Grange Castle facility in Dublin, Ireland to prepare for IMB inspection and coordinate Enbrel exhibit batches.• Reviewed batch records, and associated documentation for release of Enbrel, Refacto, and BeneFIX produced by contractors, business partners and Wyeth affiliates.• Quality Assurance single point of contact for Enbrel change control activities, coordinating contractors, business partners and Wyeth affiliates.