Beth Blomquist Email and Phone Number
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Thirty years of industry experience with depth in both the Quality and Operations organizations in leadership roles. Experience in cell/gene therapies, biologics, small molecule OSD and parenteral pharma, and consumer health. Expertise in developing and implementing Quality Systems, managing BOH inspections, investigations, change control, project implementation, cGMP compliance interpretation/ application, application of lean principles, conducting vendor audits and leading teams with a focus on development.
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Director, Cmc Audit And Inspection ManagementVertex Pharmaceuticals Feb 2021 - PresentBoston, Ma, UsGlobal process owner for Audits and Inspection Management responsible to develop and optimize procedures, metrics, tool kits, and training aids for cross GxP community of end users. Responsible for Supplier audits for small molecules and cell/gene therapy portfolios and ensuring on time qualification of key suppliers to meet business demand. Responsible for Inspection management for all GMP and GDP inspections inclusive of GMP manufacturing facilities and country affiliate offices. Responsible to set strategy for annual internal audit plan and provide guidance on remediation.
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Associate Director Audit And Inspection ManagmentVertex Pharmaceuticals Apr 2019 - Feb 2021Boston, Ma, Us
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Associate Director – Program Integration And Enhancement; Cmc And Patient Safety Quality AssuranceVertex Pharmaceuticals Dec 2017 - Apr 2019Boston, Ma, UsRepresent CMC Quality for Partnership Due Diligence and Integration activities, including assessment and integration of new modalities into existing quality systems.Oversight of the Internal Auditing program (GMP/GDP) Provide both front & back room inspection support during agency and customer inspections Provide Support for Vendor Management and Supplier Audit Activities
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Quality Assurance ConsultantComplya Consulting Group 2017 - 2017Providing subject matter expertise and project management to Pharmaceutical and Biotechnology companies in GxP environments in areas such as CMO life cycle management , Quality Systems implementation and optimization and Audit/Inspection readiness.Currently working with Vertex in Boston.
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Senior Manager- Network Development & Integration- Contract Operations Quality AssurancePfizer 2015 - 2017New York, New York, UsPartnering with Business Development conduct Due Diligence and Contractor Selection audits for new business opportunities. These initiatives may include products from Consumer, Pharma or Biotech business units. Responsibilities include post audit remediation of selected contract site, support of validation life cycle through site Qualification and negotiation of Quality Agreements. -
Sr. Manager, Quality Systems Support For CoqaPfizer 2011 - 2015New York, New York, UsLead staff of employees who perform a variety of Quality Systems (QS) functions to support ongoing GMP activities at 2nd/3rd party locations. Functions supported include batch record review and product disposition, product complaint evaluation and reporting, sample management, Annual Product Reviews, change control, investigations, Quality Agreements, and commitment tracking.
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Operations Compliance ManagerPfizer 2007 - 2011New York, New York, UsResponsible for a team of Compliance Coordinators and Investigators within the Andover Production Operations group. This group is responsible for ensuring compliance on the manufacturing floor, investigation of any manufacturing discrepancies, investigation of environmental excursions, preparing for regulatory inspections, facility certifications, multi-product risk assessments and SRC submissions. Additional responsibilities include development and reporting of departmental metrics, drafting responses for BOH observations and document review/approval.
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Manager - Qc MicrobiologyLonza Biologics 2006 - 2007Basel, ChResponsible for all aspects of the QC Microbiology department. Oversight of a group of 40 employees in various disciplines. These areas included Microbiology testing/analysis, Laboratory Information Group responsible for sample receipt/delivery from manufacturing floor, MCB/WCB maintenance, data archiving and support activities for all of QC; and the Environmental Monitoring group responsible for the collection of all air, surface and water samples in support of the facility and issuance /resolution of EARs.Additional responsibilities include maintenance of two cost center budgets, review and approval of SOPs, Investigations, Validation protocols/reports, Product Specifications, Raw Material Specifications, Regulatory submissions, C of As and Quality Agreements. Also, participate in customer meetings to give guidance on testing requirements for new products. Represent QC Microbiology during corporate, internal, customer and BOH inspections. -
Senior Supervisor, Qc MicrobiologyWyeth Biopharma 2000 - 2006
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Senior Analyst, Qc MicrobiologyGenetics Institute 1996 - 2000
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Senior Analyst, Qc MicrobiologyFisons Pharmaceuticals 1993 - 1996
Beth Blomquist Skills
Beth Blomquist Education Details
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Worcester State UniversityMinor Chemistry
Frequently Asked Questions about Beth Blomquist
What company does Beth Blomquist work for?
Beth Blomquist works for Vertex Pharmaceuticals
What is Beth Blomquist's role at the current company?
Beth Blomquist's current role is Director, CMC Audit and Inspection Management at Vertex Pharmaceuticals.
What is Beth Blomquist's email address?
Beth Blomquist's email address is be****@****zer.com
What is Beth Blomquist's direct phone number?
Beth Blomquist's direct phone number is +121257*****
What schools did Beth Blomquist attend?
Beth Blomquist attended Worcester State University.
What skills is Beth Blomquist known for?
Beth Blomquist has skills like Gmp, Change Control, Quality System, Quality Control, Fda, 21 Cfr Part 11, Microbiology, Capa, Validation, Biotechnology, Technology Transfer, Biopharmaceuticals.
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