Lead, Quality Systems

<h2>Lead, Quality Systems</h2> <h3><span class="NormalTextRun SCXW212146932 BCX0">Forge Your Future with Us</span><span class="NormalTextRun SCXW212146932 BCX0">:</span></h3> <p><span data-contrast="auto">At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins</span><span data-contrast="auto">.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">What sets Forge apart is our culture of </span><strong><span data-contrast="auto">H.O.P.E.</span></strong><span data-contrast="auto"> We are </span><strong><span data-contrast="auto">hardworking</span></strong><span data-contrast="auto">, showing up each day with determination and grit. We are </span><strong><span data-contrast="auto">open</span></strong><span data-contrast="auto">, creating a space where ideas flow freely and every voice is valued. We are </span><strong><span data-contrast="auto">purpose-driven</span></strong><span data-contrast="auto">, with every task directly tied to changing lives. And we are </span><strong><span data-contrast="auto">engaged</span></strong><span data-contrast="auto">, energized by the challenges we face and the milestones we achieve together.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.</span><span data-ccp-props="{}"> </span></p> <p><span data-ccp-props="{}"> </span></p> <h3>About the Role</h3> <p>The Quality Systems Lead provides strategic oversight and leadership within Forge’s Quality Systems organization. This role ensures the effectiveness, compliance, and continuous improvement of Forge’s quality management systems in support of GMP operations. The Lead will manage and mentor a team of specialists, driving execution of quality events, documentation systems, and CAPA programs while ensuring regulatory compliance and alignment with corporate quality objectives.<br><br>The ideal candidate demonstrates deep technical and regulatory expertise, strong leadership, and the ability to collaborate cross-functionally to strengthen Forge’s culture of quality and operational excellence.</p> <h3>What You’ll Do</h3> <ul> <li>Provide leadership and oversight for Quality Systems operations, including documentation control, change control, deviations, CAPAs, and investigations.</li> <li>Supervise and mentor Quality Systems Specialists and Senior Specialists to ensure quality deliverables are completed on time and meet compliance standards.</li> <li>Lead cross-functional quality reviews, ensuring proactive identification and resolution of systemic issues through root cause analysis and CAPA effectiveness checks.</li> <li>Develop and implement improvements to Quality Management System (QMS) workflows and documentation structures to enhance efficiency and compliance.</li> <li>Review and approve complex investigations, change controls, and controlled documents (SOPs, Work Instructions, and Forms).</li> <li>Partner with Manufacturing, Quality Control, and Process Development to ensure compliant, efficient support of operational activities.</li> <li>Support audit readiness by leading internal audit programs and representing Quality Systems during external inspections.</li> <li>Drive a culture of continuous improvement through quality metrics, trending, and data-driven decision-making.</li> <li>Ensure Forge’s QMS remains aligned with FDA, EMA, and global regulatory expectations.</li> </ul> <h3>What You’ll Bring</h3> <ul> <li>Bachelor’s degree in biological sciences, engineering, or a related STEM field (Master’s degree preferred).</li> <li>8+ years of relevant experience in GMP Quality Systems, with 2+ years of leadership or supervisory experience.</li> <li>In-depth expertise in deviation management, change control, CAPA, and root cause analysis.</li> <li>Strong working knowledge of cGMPs, GDP, and global regulatory guidance (FDA, EMA, ICH).</li> <li>Demonstrated ability to lead investigations and implement sustainable process improvements.</li> <li>Excellent organizational, communication, and leadership skills, with the ability to manage multiple priorities in a fast-paced environment.</li> <li>Proficiency in Quality Management Systems such as Veeva Vault QMS.</li> </ul> <h3>Preferred</h3> <ul> <li>Experience supporting regulatory inspections and client audits.</li> <li>Knowledge of global pharmacopeias (USP, EP, JP, BP, Ph. Eur.).</li> <li>Experience with biologics, gene therapy, or sterile injectable manufacturing.</li> <li>Familiarity with Lean or Six Sigma methodologies for process improvement.</li> </ul> <p><strong><span class="TextRun SCXW36727648 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW36727648 BCX0" data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Calibri",469777842,"Times New Roman",469777843,"Calibri",469777844,"Calibri",469769226,"Calibri,Times New Roman",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Work Environment and Physical Demands </span></span></strong><span class="TextRun SCXW36727648 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW36727648 BCX0" data-ccp-charstyle="eop" data-ccp-charstyle-defn="{"ObjectId":"920dbcde-2834-5e15-a5fa-062170b236ba|1","ClassId":1073872969,"Properties":[469777841,"Calibri",469777842,"Times New Roman",469777843,"Calibri",469777844,"Calibri",469769226,"Calibri,Times New Roman",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"Default Paragraph Font"]}"> </span></span><span class="EOP SCXW36727648 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <p><span class="TextRun SCXW81134244 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW81134244 BCX0">This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is </span><span class="NormalTextRun SCXW81134244 BCX0">largely a</span><span class="NormalTextRun SCXW81134244 BCX0"> sedentary role; persons holding office positions are </span><span class="NormalTextRun SCXW81134244 BCX0">generally subject</span><span class="NormalTextRun SCXW81134244 BCX0"> to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly </span><span class="NormalTextRun SCXW81134244 BCX0">operate</span><span class="NormalTextRun SCXW81134244 BCX0"> a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.</span></span><span class="EOP SCXW81134244 BCX0" data-ccp-props="{"134233279":true}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Calibri",469777842,"Times New Roman",469777843,"Calibri",469777844,"Calibri",469769226,"Calibri,Times New Roman",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.</span><span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{"ObjectId":"920dbcde-2834-5e15-a5fa-062170b236ba|1","ClassId":1073872969,"Properties":[469777841,"Calibri",469777842,"Times New Roman",469777843,"Calibri",469777844,"Calibri",469769226,"Calibri,Times New Roman",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"Default Paragraph Font"]}"> </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <p> </p> <p><strong><span data-contrast="auto"><span data-ccp-charstyle="eop">We’ve Got You Covered: </span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <p><span data-contrast="auto"><span data-ccp-charstyle="eop">At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. </span><span data-ccp-charstyle="eop">We’ve</span><span data-ccp-charstyle="eop"> built a comprehensive compensation and </span><span data-ccp-charstyle="eop">benefits</span><span data-ccp-charstyle="eop"> </span><span data-ccp-charstyle="eop">package</span><span data-ccp-charstyle="eop"> designed to help you thrive, grow, and feel valued every step of the way: </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span><strong><span data-contrast="auto"><span data-ccp-charstyle="eop">Health from day one</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph" data-ccp-parastyle-defn="{"ObjectId":"aaed607e-c2a3-5841-9fb4-41037bfa0faf|1","ClassId":1073872969,"Properties":[268442635,"24",469777841,"Times New Roman",469777842,"Times New Roman",469777843,"Times New Roman",469777844,"Times New Roman",469769226,"Times New Roman",469775450,"paragraph",201340122,"2",134233614,"true",469778129,"paragraph",335572020,"1",134233118,"true",134233117,"true",469778324,"Normal"]}">Health, dental and vision insurance start your first day – with 90% of premiums covered for you </span></span><em><span data-contrast="auto"><span data-ccp-parastyle="paragraph">and</span></span></em><span data-contrast="auto"><span data-ccp-parastyle="paragraph"> your family. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Time to recharge</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">A competitive paid time off plan – because rest </span><span data-ccp-parastyle="paragraph">fuels</span><span data-ccp-parastyle="paragraph"> innovation. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">12 weeks</span><span data-ccp-parastyle="paragraph"> of fully paid parental leave so you can focus on family when it matters most. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Rewarding your impact</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Annual bonus opportunities for all full-time team members. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">401(k) with company match to help you </span><span data-ccp-parastyle="paragraph">plan for the future</span><span data-ccp-parastyle="paragraph">. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Special employee discounts, including childcare and dependent care savings. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Your wellness, supported</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Onsite fitness facility at The Hearth.</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Mental health counseling and financial planning services through our Employee Assistance Program. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="17" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Employer-paid short and long-term disability coverage to protect your peace of mind. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Fuel for your workday</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">A fully </span><span data-ccp-parastyle="paragraph">stocked</span><span data-ccp-parastyle="paragraph"> kitchen with free </span><span data-ccp-parastyle="paragraph">snacks</span><span data-ccp-parastyle="paragraph"> and beverages – we keep you energized and ready for </span><span data-ccp-parastyle="paragraph">what’s</span><span data-ccp-parastyle="paragraph"> next. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Grow with us</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="paragraph">Ongoing professional development resources, training, and mentorship programs to help you build your </span><span data-ccp-parastyle="paragraph">care</span><span data-ccp-parastyle="paragraph"> and grow within Forge. </span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":180,"335559738":0,"335559739":0}"> </span></p> <p> </p> <p> </p>