Chris Zilich, MBA
Associate Director, Quality Systems and Compliance at Blueprint Medicines- Claim this Profile
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Bio
Brie Stoianoff
Over the time that I have worked with Chris, I have found him to be one of the most delightful individuals to work with. He understands the challenges that arise on both sides and works collaboratively with his team and mine to find a solution that works for all involved. When he makes a commitment to complete something, he does, and communication throughout the process is seamless, transparent and honest. I couldn't ask for a better business partner than Chris!
Tim L.
As a Sr. QA associate with Dendreon, Chris Zilich worked closely with me and the Technical Services group as a change analyst and agent on a number of large and complex process improvement projects. He designed and delivered a training program for a revamped change control system and proved himself an effective communicator and patient teacher. With an excellent attention to detail and a collaborative style, Chris became the "go-to" person for QA analysis and administration of global technical changes and process improvement initiatives. Chris balanced the highly responsible and critical role of QA oversight with proactive and direct support of cross-functional change owners and project managers from departments including QC, QA, Manufacturing, IT/eSystems, and Contract Manufacturing, asking the right questions to drive projects forward while ensuring robust planning, successful implementation, and timely goal completion. With a fun sense of humor, he is a natural at building a sense of comraderie among the teams he works. Chris' skills and experience make him a strong candidate for a broad range of roles in GxP and technical fields, and he has my enthusiastic recommendation.
Brie Stoianoff
Over the time that I have worked with Chris, I have found him to be one of the most delightful individuals to work with. He understands the challenges that arise on both sides and works collaboratively with his team and mine to find a solution that works for all involved. When he makes a commitment to complete something, he does, and communication throughout the process is seamless, transparent and honest. I couldn't ask for a better business partner than Chris!
Tim L.
As a Sr. QA associate with Dendreon, Chris Zilich worked closely with me and the Technical Services group as a change analyst and agent on a number of large and complex process improvement projects. He designed and delivered a training program for a revamped change control system and proved himself an effective communicator and patient teacher. With an excellent attention to detail and a collaborative style, Chris became the "go-to" person for QA analysis and administration of global technical changes and process improvement initiatives. Chris balanced the highly responsible and critical role of QA oversight with proactive and direct support of cross-functional change owners and project managers from departments including QC, QA, Manufacturing, IT/eSystems, and Contract Manufacturing, asking the right questions to drive projects forward while ensuring robust planning, successful implementation, and timely goal completion. With a fun sense of humor, he is a natural at building a sense of comraderie among the teams he works. Chris' skills and experience make him a strong candidate for a broad range of roles in GxP and technical fields, and he has my enthusiastic recommendation.
Brie Stoianoff
Over the time that I have worked with Chris, I have found him to be one of the most delightful individuals to work with. He understands the challenges that arise on both sides and works collaboratively with his team and mine to find a solution that works for all involved. When he makes a commitment to complete something, he does, and communication throughout the process is seamless, transparent and honest. I couldn't ask for a better business partner than Chris!
Tim L.
As a Sr. QA associate with Dendreon, Chris Zilich worked closely with me and the Technical Services group as a change analyst and agent on a number of large and complex process improvement projects. He designed and delivered a training program for a revamped change control system and proved himself an effective communicator and patient teacher. With an excellent attention to detail and a collaborative style, Chris became the "go-to" person for QA analysis and administration of global technical changes and process improvement initiatives. Chris balanced the highly responsible and critical role of QA oversight with proactive and direct support of cross-functional change owners and project managers from departments including QC, QA, Manufacturing, IT/eSystems, and Contract Manufacturing, asking the right questions to drive projects forward while ensuring robust planning, successful implementation, and timely goal completion. With a fun sense of humor, he is a natural at building a sense of comraderie among the teams he works. Chris' skills and experience make him a strong candidate for a broad range of roles in GxP and technical fields, and he has my enthusiastic recommendation.
Brie Stoianoff
Over the time that I have worked with Chris, I have found him to be one of the most delightful individuals to work with. He understands the challenges that arise on both sides and works collaboratively with his team and mine to find a solution that works for all involved. When he makes a commitment to complete something, he does, and communication throughout the process is seamless, transparent and honest. I couldn't ask for a better business partner than Chris!
Tim L.
As a Sr. QA associate with Dendreon, Chris Zilich worked closely with me and the Technical Services group as a change analyst and agent on a number of large and complex process improvement projects. He designed and delivered a training program for a revamped change control system and proved himself an effective communicator and patient teacher. With an excellent attention to detail and a collaborative style, Chris became the "go-to" person for QA analysis and administration of global technical changes and process improvement initiatives. Chris balanced the highly responsible and critical role of QA oversight with proactive and direct support of cross-functional change owners and project managers from departments including QC, QA, Manufacturing, IT/eSystems, and Contract Manufacturing, asking the right questions to drive projects forward while ensuring robust planning, successful implementation, and timely goal completion. With a fun sense of humor, he is a natural at building a sense of comraderie among the teams he works. Chris' skills and experience make him a strong candidate for a broad range of roles in GxP and technical fields, and he has my enthusiastic recommendation.
Credentials
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Managing Organizational Change for Managers
LinkedInOct, 2021- Nov, 2024
Experience
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Blueprint Medicines
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United States
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Biotechnology Research
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400 - 500 Employee
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Associate Director, Quality Systems and Compliance
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Jul 2022 - Present
Audit, Inspection, and Vendor Management functional area leadership within Blueprint Medicines global Quality Assurance organization. Audit, Inspection, and Vendor Management functional area leadership within Blueprint Medicines global Quality Assurance organization.
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Wave Life Sciences
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United States
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Biotechnology Research
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200 - 300 Employee
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Quality Assurance Consultant
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Jan 2022 - Jul 2022
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Ambry Genetics
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United States
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Biotechnology Research
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400 - 500 Employee
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Senior Manager, GMP Quality
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Aug 2020 - Dec 2021
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Vertex Pharmaceuticals
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United States
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Biotechnology Research
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700 & Above Employee
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Audit Manager
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Oct 2019 - Aug 2020
Audit and Inspection Management QA
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Quality Assurance Manager
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Dec 2016 - Oct 2019
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CMC and Patient Safety QA
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May 2016 - Dec 2016
Assist with oversight of vendor management program in CMC and Patient Safety QA team.
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Roche Sequencing USA
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United States
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Biotechnology Research
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100 - 200 Employee
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QA Manager
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Dec 2014 - Oct 2015
Developing both site and corporate QMS to prepare for ISO 9001 certification of US site. Harmonizing QA standards where applicable with manufacturing site in Cape Town, South Africa. Establishing training program for US site. Facilitating Safety Committee Meetings and finalizing both site Safety Policy and training. Developing both site and corporate QMS to prepare for ISO 9001 certification of US site. Harmonizing QA standards where applicable with manufacturing site in Cape Town, South Africa. Establishing training program for US site. Facilitating Safety Committee Meetings and finalizing both site Safety Policy and training.
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Omeros Corporation
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United States
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Biotechnology Research
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100 - 200 Employee
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QA Associate
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Sep 2013 - Dec 2014
Auditing GxP Quality Systems documentation and authoring revisions of SOPs as needed. Ensuring master batch records are reconciled and creating an archival process for MBRs. Developing change control process for CMO/CRO entities in Omeros network for US and EU standards. Auditing GxP Quality Systems documentation and authoring revisions of SOPs as needed. Ensuring master batch records are reconciled and creating an archival process for MBRs. Developing change control process for CMO/CRO entities in Omeros network for US and EU standards.
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Dendreon
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United States
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Biotechnology Research
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300 - 400 Employee
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Sr. QA Associate
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Nov 2010 - Nov 2012
Responsible for the management of corporate change control and assistance of other QA Systems Assisted in creation of Rest of World change management workflow, based on European Union medicine EMEA requirements. Created change control review board procedure and requirements, as well as performed both the scheduling and facilitation of board meetings. Responsible for the management of corporate change control and assistance of other QA Systems Assisted in creation of Rest of World change management workflow, based on European Union medicine EMEA requirements. Created change control review board procedure and requirements, as well as performed both the scheduling and facilitation of board meetings.
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Seattle Cancer Care Alliance
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United States
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Hospitals and Health Care
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700 & Above Employee
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QA Associate II
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Jan 2010 - Nov 2010
GCP/GTP QA oversight of Apheresis and Cellular Therapy Departments. Oversaw the environmental monitoring program for the cellular therapy laboratory. This included producing trending and quarterly reports for site leadership. Assisted with successful process and systems regulatory audit of cord blood donor bank and followed through with the closing report of the audit activity. GCP/GTP QA oversight of Apheresis and Cellular Therapy Departments. Oversaw the environmental monitoring program for the cellular therapy laboratory. This included producing trending and quarterly reports for site leadership. Assisted with successful process and systems regulatory audit of cord blood donor bank and followed through with the closing report of the audit activity.
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ZymoGenetics
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Biotechnology
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100 - 200 Employee
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Senior QA Associate
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Jul 2008 - Jan 2010
Subject matter expert for change control and deviation processes for regulatory audits. Performed QA review of GLP data, methods, protocols, and SOPs. Benchmarked quality systems metrics with specific GxP functions and established internal system audits. Chair of change control review board for site-wide GxP changes. Subject matter expert for change control and deviation processes for regulatory audits. Performed QA review of GLP data, methods, protocols, and SOPs. Benchmarked quality systems metrics with specific GxP functions and established internal system audits. Chair of change control review board for site-wide GxP changes.
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Sterling Reference Laboratories
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Tacoma, WA
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Senior Certifying Scientist
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Jun 2007 - Jul 2008
Responsible for final data release of positive toxicology reports and answering of technical questions for clientele. Reviewed data to ensure accuracy of Sysware PowerLAB reports. Assisted the Technical Director of Quality Assurance of lab reporting with respect to CLIA and SAMHSA standards and implemented corrective actions as needed. Responsible for final data release of positive toxicology reports and answering of technical questions for clientele. Reviewed data to ensure accuracy of Sysware PowerLAB reports. Assisted the Technical Director of Quality Assurance of lab reporting with respect to CLIA and SAMHSA standards and implemented corrective actions as needed.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Assistant QA Scientist
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Nov 2001 - Apr 2007
Project leader for emerging cleaning qualifications with validation groups that support Advair and Relenza production, as well as critical utilities. Completed project to qualify cleaning SOPs for new blending and filling equipment to support Advair/Relenza production. Created a new system of trending QA data by utilizing two validated systems: SAP R/3 and Statistica. Developed an SOP to import validated data into Statistica for graphical analysis of quarterly data, and trained colleagues on executing this function. Became a key figure in the root cause analysis of problems installing a low-pressure nitrogen regulator in a critical utility system. Trained to become LeanSigma Green Belt and did active research on streamlining workflow, controlling cross-contamination areas, and assisting with internal auditing of QC laboratories. Show less
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Apex Bioscience Inc
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Research Triangle Park, NC
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Production/Process Development Associate
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Jun 2001 - Oct 2001
Responsible for cGMP production and cGLP process development of a hemoglobin-based parenteral. Assisted in development studies such as viral clearance, deoxygenation, and process optimization. Performed protein purification utilizing HIC and IEC techniques. Authored company SOPs pertaining to the operation of the Sartochek 3 automated filter integrity tester. Responsible for cGMP production and cGLP process development of a hemoglobin-based parenteral. Assisted in development studies such as viral clearance, deoxygenation, and process optimization. Performed protein purification utilizing HIC and IEC techniques. Authored company SOPs pertaining to the operation of the Sartochek 3 automated filter integrity tester.
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Education
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2012 - 2014
University of Washington, Michael G. Foster School of Business
Master of Business Administration (M.B.A.), Technology Management -
1995 - 1999
Florida Institute of Technology
B.S., Biology
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