Janet Stevens

Janet Stevens Email and Phone Number

Global Quality Executive I Board Member | Pharma & Medical Device Industry | DE&I | Risk Mitigation | QA, Operations & Engineering @ hims & hers
Janet Stevens's Location
Chicago, Illinois, United States, United States
Janet Stevens's Contact Details
About Janet Stevens

I am a global, high-integrity Chief Quality Officer and Business Executive in the pharmaceuticals and medical device technology industries, with extensive experience in QA, operations, and engineering. Combined with this nationally-recognized domain expertise, I am further known as a community and thought leader who brings proven experience in transformational change, executive succession and development, enterprise governance and compliance, ERG, and DE&I.Most recently, I served in the C-Suite Executive Team of Hillrom, a $3B medical technology company, until its acquisition by Baxter International where I served on the M&A Committee. At Hillrom, as the VP & Chief Quality Officer I oversaw an organization of 350+ people, addressing Quality enterprise-wide across 3 global business units and directed several enterprise-wide quality transformation initiatives leading to top-quartile results related to global quality regulations.Prior to Hillrom, as VP, Sterile Injectable Quality Operations at Pfizer, Inc. and Hospira (2007-19), I was recognized for transforming the company’s quality organization, enabling successful regulatory inspections globally. I established key relationships with regulatory authorities such as FDA, MHRA, and Health Canada. In that role, I led both the international and domestic Quality Business Units (>1K employees worldwide & 8 global plants), gaining expertise in the APAC region. I lived and worked in India where I led a greenfield project in Ahmedabad, India to produce sterile products for global markets, exceeding $3M.I have served as a key influencer and advisor to the Board of Directors at both Hillrom and Hospira. As a member of many professional and community organizations, I mentor aspiring African American engineers, furthering diversity in STEM career fields. I chaired the inaugural Diversity and Inclusion Employee Resource Group (ERG) Chicago chapters for both Hillrom and Pfizer. Currently, I am a member of the DE&I Committee of the WBL Foundation.I was the 2019 Commencement speaker at The Young Women’s Leadership Charter School in Chicago, and is a member of iMentor Chicago, Women Corporate Directors (WCD) BoardNext initiative.AREAS OF EXPERTISE RELEVANT TO BOARD SERVICE:Environmental, Social & Governance – Strategy & Compliance • Organizational TransformationDiversity, Equity & Inclusion • Executive Succession PlanningQuality, Compliance & Operational Excellence • Budget/Capital PlanningSix Sigma/Lean Manufacturing • Risk ManagementManagement of Regulatory Relationships, Submissions, and Inspections

Janet Stevens's Current Company Details
hims & hers

Hims & Hers

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Global Quality Executive I Board Member | Pharma & Medical Device Industry | DE&I | Risk Mitigation | QA, Operations & Engineering
Janet Stevens Work Experience Details
  • Hims & Hers
    Global Head Of Quality
    Hims & Hers Dec 2024 - Present
    San Francisco, California, Us
    As the Global Head of Quality, I am responsible for Quality at Hims. This includes Quality Systems, Quality Operations, and Quality Control. Driving Quality excellence and innovation in personalized solutions to help people feel great through better health.
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  • Jl Stevens Consulting, Llc
    Owner And President
    Jl Stevens Consulting, Llc Sep 2022 - Present
    Operations and Quality consulting firm. Focused operational and quality expertise in transformation, remediation, M&A integration, and achieving top quartile results in both the medical device and pharmaceutical industry.
  • Jmd Angels Foundation
    Member Board Of Directors
    Jmd Angels Foundation Jan 2023 - Present
    The JMD Angels Foundation, Inc, was founded to provide assistance to our community's most vulnerable citizens. Our goal is to assist with eligible individuals in the Chicagoland community with clothing, food, shelter and scholarships. Info: https://jmdangelsfoundation.com
  • Women Business Leaders Of The Us Health Care Industry Foundation (Wbl)
    Diversity, Equity & Inclusion (De&I) Committee Member
    Women Business Leaders Of The Us Health Care Industry Foundation (Wbl) Apr 2021 - Present
    Arlington, Virginia, Us
    A Member of the DE&I Committee since Jan 2022 and a Member since April 2021. Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) is a national nonprofit organization that brings together a peer group of senior executive women from all parts of the health care industry, comprising a network of more than 3,000 women.
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  • Hillrom
    Vice President Quality Assurance
    Hillrom May 2020 - Jan 2022
    Chicago, Il, Us
    As Chief Quality Officer/Head of QA, led a team of 6 direct reports (350+ people organization) & oversaw Quality enterprise-wide across 3 global business units. Member, Executive Leadership Team (C-Suite). Built a best-in-class leadership team & widened team by including Commercial Quality as part of the Quality Leadership Team (QLT). Created a transparent/transformative quality culture that drives continuous improvement.• Increased QA team’s focus and performance by providing clear expectations and guidance to define a Top Quartile QA organization• Enabled improvements in efficiency and leadership by leading enterprise-wide transparency improvements through standardization:• Enabled Leadership to continue to have confidence in the suitability/ effectiveness of Hillrom’s Quality management system: established robust and comprehensive Quality System metrics, including metrics for R&D, Operations, Supplier Quality, Quality Systems, and Post-market Surveillance • Improved Field Action quality decision making through creation/implementation of global processes to better execute field action strategies:• Enhanced Hillrom’s protection and reduced its risk by revamping the audit program.
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  • Pfizer
    Vp Quality Operations, Sterile Injectables
    Pfizer Sep 2009 - Jun 2019
    New York, New York, Us
    Led a Business Unit with 1000 employees worldwide for 8 global sterile injectable manufacturing sites. (international from 2015 – 2019). Led remediation to meet regulatory expectations and compliance, thereby ensuring continued product supply. Enabled successful regulatory inspections globally for sterile injectables, obtained domestic/ international FDA acceptable site status, VAI or NAI by establishing robust remediation plans. Established key relationships with regulatory authorities (FDA, MHRA, and Health Canada).• Maintained/enhanced site and corporate quality assurance and built capability: • Addressed India’s data integrity challenges: dealt with key compliance challenges and existing siloes by fostering consistent quality strategies, connectivity and collaboration • Remediated sites and consistently communicated to the FDA to ensure sites were moving in the trajectory to cGMP compliance.
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  • Hospira
    Director, Quality Alliance Management
    Hospira Aug 2007 - Sep 2009
    Lake Forest, Il, Us
    Managed, executed, and drove successful results for global approval of a “greenfield site” in Ahmedabad, India. Obtained MHRA and FDA approval for sterile injectable oncolytic site by leading a Lake Forest / India cross-functional leadership team (Quality, Operations, and Regulatory).
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  • Abraxis Bioscience
    Director Of Quality
    Abraxis Bioscience Apr 2005 - Jul 2007
    Los Angeles, Ca, Us
    Led quality unit operations for manufacturing quality assurance (MQA), chemistry/microbiology laboratories, release, critical systems, and site compliance. Oversaw ~$15M/year budget. Aligned staff of ~100 non-union employees, 6 managerial direct reports with the 6 FDA quality systems. Developed plant goals with Executive and site management teams. Reduced overall deviations by 10% YoY, successfully managed FDA inspections.
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  • Eli Lilly
    Manager, Quality Systems
    Eli Lilly Dec 2002 - Mar 2005
    Indianapolis, Indiana, Us
    Managed Global Material Quality System development/deployment. Created Global Material Quality Standards. Enabled consistent implementation at manufacturing sites by developing global strategies for supplier quality mgt processes utilizing risk mgt principles. Enabled Company to have a voice in critical joint response to EMEA excipient directive (IPEC/PQG/ EFPIA) by serving as its representative—effort led to creation of global directive for excipient mgt.
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  • Baxter Bioscience
    Business Unit Manager
    Baxter Bioscience Sep 1989 - Nov 2002
    Deerfield, Illinois, Us
    Baxter BioScience, Round Lake, IL, Los Angeles, CA, BU Manager, Therapeutic Proteins, 2000– 2002. Business Unit Manager responsible for bulk formulation, aseptic filling, lyophilization, and packaging departments; 213 non-union employees with 4 direct reports. Developed and maintained $50M yearly budget.Baxter Drug Delivery, Round Lake, IL, progressive roles, 1989 – 2000.
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Janet Stevens Skills

Capa V&v Fda Change Control Gmp Aseptic Processing Validation Lims 21 Cfr Part 11 Sop Glp Regulatory Affairs Calibration Dmaic Gxp Iso 13485 Medical Devices Pharmaceutical Industry Quality Assurance Quality Auditing Quality Control Quality Management Quality System Root Cause Analysis Trackwise Six Sigma

Janet Stevens Education Details

  • Depaul Driehaus College Of Business
    Depaul Driehaus College Of Business
    Operations And Finance
  • Purdue University
    Purdue University
    Industrial Engineering

Frequently Asked Questions about Janet Stevens

What company does Janet Stevens work for?

Janet Stevens works for Hims & Hers

What is Janet Stevens's role at the current company?

Janet Stevens's current role is Global Quality Executive I Board Member | Pharma & Medical Device Industry | DE&I | Risk Mitigation | QA, Operations & Engineering.

What is Janet Stevens's email address?

Janet Stevens's email address is ja****@****rom.com

What is Janet Stevens's direct phone number?

Janet Stevens's direct phone number is (716)-684*****

What schools did Janet Stevens attend?

Janet Stevens attended Depaul Driehaus College Of Business, Purdue University.

What are some of Janet Stevens's interests?

Janet Stevens has interest in Football, Grandkids, Exercise, Sweepstakes, Home Improvement, Reading, Gourmet Cooking, Sports, Watching Auto Racing, Watching Basketball.

What skills is Janet Stevens known for?

Janet Stevens has skills like Capa, V&v, Fda, Change Control, Gmp, Aseptic Processing, Validation, Lims, 21 Cfr Part 11, Sop, Glp, Regulatory Affairs.

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