Suzanne Mullins

Suzanne Mullins Email and Phone Number

Independent Consultant @ Chevy Chase Village, MD, US
Chevy Chase Village, MD, US
Suzanne Mullins's Location
Chevy Chase, Maryland, United States, United States
Suzanne Mullins's Contact Details

Suzanne Mullins work email

Suzanne Mullins personal email

n/a
About Suzanne Mullins

A qualified and results-oriented quality assurance professional specializing in the biopharmaceutical industry with vast expertise in GCP, GDP, GLP, GMP, GVP, CSV and clinical program management. Possesses additional capabilities in company integrations, due diligence, and records management. Demonstrates a thorough domestic and international understanding of compliance and regulatory matters and a proven track record of maximizing an organization's effectiveness, implementing continuous improvement processes, and achieving business goals. An accomplished and visionary leader with an unwavering commitment to quality and excellence.Key Accomplishments* Established global QA function from ground up for three pharma/biotech companies* Converted drug metabolism and genomics laboratories into GLP-compliant laboratories* Hosted and/or supported regulatory agency inspections and inquiries, including FDA, EMA, MHRA, DEA, USDA, MD Board of Pharmacy, and Swissmedic.

Suzanne Mullins's Current Company Details
Senior QA Consultant

Senior Qa Consultant

Independent Consultant
Chevy Chase Village, MD, US
Suzanne Mullins Work Experience Details
  • Senior Qa Consultant
    Independent Consultant
    Senior Qa Consultant
    Chevy Chase Village, Md, Us
  • Self-Employed
    Independent Quality Assurance Consultant
    Self-Employed 2016 - Present
    Provides a broad range of Good Quality Practice (GxP) Quality Assurance (QA) consulting services.
  • Sucampo Pharmaceuticals
    Senior Director, Quality Assurance
    Sucampo Pharmaceuticals 2012 - 2015
    Rockville, Md, Us
    Established and provided strategic direction. Oversaw design, development, execution, and administration of global GXP quality management system in accordance with national and international GCP, GDP, GLP, GMP, GVP, CSV, and data privacy standards and regulatory compliance requirements. Performed QA oversight and support of US launch of RESCULA® and UK launch of AMITIZA® and ongoing manufacturing and supply chain activities.
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  • Macrogenics
    Sr. Director, Clinical Quality Assurance
    Macrogenics 2008 - 2012
    Rockville, Md, Us
    Established GCP QA function from ground up for ongoing pivotal clinical programs to ensure overall GCP and data privacy compliance with domestic and international laws, regulations, and guidelines. Identified areas of regulatory/business risk, provided input into development of clinical infrastructure, including cGMP processes for clinical trial materials. Advised senior management on quality- and regulatory compliance-related matters.
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  • Bridge Gps, Inc. (Previously Gene Logic Laboratories, Inc.)
    Vp, Global Compliance
    Bridge Gps, Inc. (Previously Gene Logic Laboratories, Inc.) 2005 - 2008
    Performed oversight of quality and regulatory systems. Developed quality and regulatory systems to meet national and international regulatory requirements. Oversaw quality and regulatory systems for US and Beijing, PRC, including implementation of plan for development of corporate SOPs and alignment with company requirements, both globally and at site level. Ensured effective GLP QA, health and safety, GLP archiving, metrology, and animal welfare programs. Provided guidance, direction, and review to ensure effective oversight and management of facilities functions.
  • Shire Pharmaceutical Development, Inc.
    Sr. Director/Director, Quality Systems
    Shire Pharmaceutical Development, Inc. 2001 - 2005
    Tokyo, Jp, Jp
    Established and managed GCP/GLP QA function from the ground up, overseeing all GCP/GLP quality assurance initiatives and cGMP processes for clinical trial materials for ongoing clinical programs. Collaborated cross-functionally with other corporate affiliates to develop and implement quality infrastructure. Performed GAP analyses to identify areas of regulatory/business risk, target areas for process improvement, and advised SPD senior management on quality-related matters. Provided quality oversight and guidance for implementation and validation of global quality, clinical, and pharmacovigilance computer systems. Served as global head of R&D QA for GCP/GLP QA groups in US and UK.
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  • Astrazeneca (Formerly Astra Pharmaceuticals And Astra Merck)
    Development Program Director; Gcp/Glp Quality Solutions Liaison
    Astrazeneca (Formerly Astra Pharmaceuticals And Astra Merck) 1995 - 2001
    Cambridge, Cambridgeshire, Gb
    As Development Program Director, oversaw planning, development, execution, and management of drug development programs, both strategic and tactical within matrix environment in alignment with US and global teams based in Sweden and UK. Served as co-leader of clinical project team with Procter & Gamble as part of strategic alliance to develop and market over-the-counter version of PRILOSEC® in US. Directed development, compilation, management, and analysis of human resource and financial budget needs for drug development per US and global objectives.Served as GCP/GLP Quality Solutions Liaison.
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  • Glaxo Inc (And Glaxo Research & Development)
    Senior Regulatory Compliance Auditor
    Glaxo Inc (And Glaxo Research & Development) 1991 - 1995
    Developed, managed, and conducted audit/inspection strategies for nonclinical and clinical quality assurance functions in accordance with company standard operating procedures, corporate quality standards, and national/international GCP and GLP regulations, directives, and guidelines.

Suzanne Mullins Skills

Quality Assurance Sop Gcp Glp Clinical Development Clinical Research R&d Program Management Management Auditing Training Fda Biotechnology 21 Cfr Part 11 Validation Gmp Quality System Clinical Trials Good Clinical Practice Good Laboratory Practice Pharmaceutical Industry Standard Operating Procedure U.s. Food And Drug Administration

Suzanne Mullins Education Details

  • University Of North Carolina At Chapel Hill
    University Of North Carolina At Chapel Hill
    Bs

Frequently Asked Questions about Suzanne Mullins

What company does Suzanne Mullins work for?

Suzanne Mullins works for Senior Qa Consultant

What is Suzanne Mullins's role at the current company?

Suzanne Mullins's current role is Independent Consultant.

What is Suzanne Mullins's email address?

Suzanne Mullins's email address is mu****@****ast.net

What schools did Suzanne Mullins attend?

Suzanne Mullins attended University Of North Carolina At Chapel Hill.

What skills is Suzanne Mullins known for?

Suzanne Mullins has skills like Quality Assurance, Sop, Gcp, Glp, Clinical Development, Clinical Research, R&d, Program Management, Management, Auditing, Training, Fda.

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