Hello everyone! I'm Beverly P. Chase, a seasoned and solutions-orientedexecutive with a proven history of success strategizing and implementingrobust plans to ensure quality oversight and support for all GxP activities,while ensuring comprehensive document review.• With full confidence in my ever-growing experience, I like to offer myexpertise in developing and incorporation of Quality Management Systems(QMS).• I possess strong expertise and proficiency in coaching, mentoring, andleading diverse teams by providing robust training to maximize professionaland business development.• Throughout my career, I've headed the successful completion of multiplemajor projects and change processes to ensure the attainment of prescribedtargets.• As a self-managed leader, I've fostered strengthened relationships withmanagement, vendors, and clients along with addressing key issues as asubject matter expert.• As my professional career continues to evolve, I remain steadfast in mybelief that collaboration is the key to business success therefore I nowlook for many career-focused and leadership opportunities ahead.Core competencies include:• Strategic Planning & Execution• Risk Assessment & Mitigation• Quality Assurance & Control• GLP & GMP Proficient• Standard Operating Procedures (SOPs)• Continuous Improvement• Auditing & Inspection• Vendor/Supplier Management• Governance Frameworks & Metrics• Team Development & Leadership• Cross-functional Collaboration• Stakeholder EngagementConnect with me today to find out how I will make your mission my mission,to help bring all of your business objectives into focus! Please feel freeto contact me at biopharmqa@gmail.com with any thoughts, comments, orquestions about my work – I am always interested in making new professionalacquaintances.
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Director, Supplier Management QaEngene Apr 2024 - PresentSt-Laurent, Quebec, Ca -
Managing DirectorBiopharm Qa Consulting (Cgmp, Glp) Oct 2022 - PresentManage multiple key tasks such as conducting both internal and externalcGMP and GLP audits along with conducting an in-depth documentation review.• Steer management of SOP authoring and review as well as QMS developmentand gap analysis.• Incorporate appropriate approaches to cater to QMS development, whileintegrating training modules for GLPs and GMPs.• Organize batch record reviews for the release of Drug Products to theclinic.• Administer control over Change Control and Deviation (Quality Event)Management.
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Associate Director, External QualityNgm Bio May 2022 - Apr 2023Responsibilities:I navigated quality-related tasks, such as assessing protocols, changerecords, and reports to further ensure approval of quality events inadherence to GMP requirements. I contributed to the execution of all qualityassurance processes for Contract Manufacturing Organization (CMOs). Iorganized batch record reviews and secured approval for drug substances,drug products, and finished goods. I managed final release documents forbatches, including material disposition, certificate of analysis (CoA), andcertificate of release (CoR).Key Accomplishments:• Led internal SOP review and approval, tech transfer document review, andCMO Selection.• Oversaw creation and execution of SOPs to ensure the achievement ofcontinuous improvement.
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Associate Director, Nonclinical QualityTaysha Gene Therapies Dec 2021 - Jun 2022Dallas, Tx, UsResponsibilities:I performed a comprehensive review of nonclinical protocols, reports, andSOPs in compliance with GLP requirements. I managed a detailed audit of allnonclinical vendors to ensure Good Laboratory Practice (GLP) compliance. Iefficiently processed Translational Sciences SOPs and Work Instructions byutilizing Veeva. I monitored non-clinical studies in close liaison withTranslational Science Team.Key Accomplishments:• Trained, coached, and developed nonclinical and laboratory teams onoptimum control of GLPs and other SOPs.• Executed complete review and approval protocols as well as audited severalanimal facilities.• Facilitated implementation of various projects by collaborating with otherdevelopment team members. -
Director Of QualityImmunovant Dec 2018 - May 2021New York, UsResponsibilities:I managed company-wide quality activities as well as developed andincorporated GxP compliance strategies in adherence to global regulations. Iproduced new QMS documents for integrated systems for start-up operations tostreamline QA, CMC, and clinical compliance. I advised quality/compliancesolutions to project teams as a focal point of contact across the ImmunovantDevelopment group. I established vendor quality by interfacing withclinical, nonclinical, and CMC and by managing relationships with criticalvendors. I facilitated the review and approval of all CMC study protocolsand reports. I evaluated deviations, CAPAS, and change controls to ensurethe assessment of root causes and execution of remedial actions.Key Accomplishments:• Headed internal and external audit programs, as per US, European, andglobal Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), andGood Laboratory Practice (GLP).• Created and executed SOP for batch record review and assessment of batchrecords for release.• Launched, incorporated, and expanded QMS into an electronic managementsystem (ACE).• Responsible for 90% of external audits for start-up vendors.• Acted as key spokesperson to effectively negotiate Quality Agreements. -
Site Compliance Team LeaderGsk Mar 2015 - Apr 2018Brentford, Middlesex, GbResponsibilities:I directed five direct reports and established inspection readiness for allregulatory inspections across the site. I managed all areas of regulatoryinspections, including control room and inspection room activities. Isupervised responses and CAPAs for submission from regulatory inspections bydeveloping a team of SMEs to create appropriate responses. I oversaw CAPAverifications for critical deviations across the site and for L4(regulatory) inspections. I trained and coached on various metrics alongwith reporting from the site's SAP system. I acted as quality counciladministrator for monthly management review meetings.Key Accomplishments:• Led completion of (Trackwise) entries and monitoring of L4 InspectionCAPAs as well as L2 (internal) audits through the development ofcomprehensive audit reports.• Led QMS Champion, DEA process owner, CAPA Verification process owner,Periodic Product Review (PPR) process owner, and L2 Process Owner.• Delivered training on the complete periodic product review process at thesite.• Generated major process improvements for systems within the team.• Recognized and acquired GSK auditor certification. -
Qc ManagerBioagilytix Labs, Inc. Mar 2013 - Jul 2014Durham, Nc, Us -
Qa LeaderHumacyte Mar 2011 - Dec 2012Develop and Implement cGMP Quality Systems (Documentation, Training, CAPA, Deviations, Record Retention, Batch Record Review, Internal Audit Program, Batch Release, and Raw Material Receipt and Release) in a biotech facility. Write Quality SOPs, support manufacturing by assisting with writing SOPs and revising them as manufacturing evolved from producing R&D material to producing Phase I/II clinical material. Perform cGMP and GLP training. Support the Study Director with Protocol and Report review for GLP studies completed at a CRO facility. Performed external audits for CROs.
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Contract-AuditorTalecris Biotherapeutics Apr 2010 - Jul 2010Reviewed Protocols and Reports for compliance to GLP regulations for the Virology Department in RTP.
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Manager, Laboratory ComplianceGilead Sciences Sep 2008 - Apr 2010Foster City, Ca, UsHighlights:• Aided in clinical and pre-clinical studies by synergizing with the studydirectors, study monitors, and laboratory managers as the GLP subject matterexpert.• Managed planning and execution of 10 external audits per year ofcontracted bioanalytical laboratories and toxicology laboratories. -
Quality ManagerAlmac Diagnostics Sep 2006 - Aug 2008
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Senior ManagerCellzdirect, Inc Nov 2005 - Sep 2006
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Senior Manager/Qa AuditorBiogen Idec May 2004 - Sep 2005Cambridge, Ma, Us -
ManagerBiogen Idec Sep 2001 - May 2004Cambridge, Ma, Us
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Manufacturing Senior SupervisorBiogen Idec Jun 1998 - Sep 2001Cambridge, Ma, Us
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Bioassay Analyst IiBiogen Idec Feb 1997 - Jun 1998Cambridge, Ma, Us
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Lab TechBayer Nov 1991 - Feb 1997Leverkusen, North Rhine-Westphalia, De
Beverly Chase Education Details
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North Carolina State UniversityZoology
Frequently Asked Questions about Beverly Chase
What company does Beverly Chase work for?
Beverly Chase works for Engene
What is Beverly Chase's role at the current company?
Beverly Chase's current role is Director, Supplier Management.
What schools did Beverly Chase attend?
Beverly Chase attended North Carolina State University.
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