Manager, Quality Systems

<p><strong><span data-contrast="auto">About&nbsp;Parabilis&nbsp;Medicines</span></strong><span data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:259}">&nbsp;</span></p> <p><span data-contrast="none">Parabilis&nbsp;Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long&nbsp;considered undruggable.&nbsp;The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational&nbsp;medicine,&nbsp;zolucatetide, is the first and only direct inhibitor&nbsp;of the&nbsp;β-catenin:TCF&nbsp;interaction,&nbsp;a central node in the&nbsp;Wnt/β-catenin pathway that has&nbsp;eluded drug developers&nbsp;for decades.&nbsp;Zolucatetide&nbsp;is being evaluated in the clinic across multiple&nbsp;Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP)&nbsp;and&nbsp;a range&nbsp;of&nbsp;other&nbsp;solid tumor indications. Beyond&nbsp;zolucatetide,&nbsp;Parabilis&nbsp;is advancing additional&nbsp;Helicon-based&nbsp;programs focused on other challenging targets&nbsp;where we believe&nbsp;our&nbsp;medicines could have life-altering impact. For more information, visit </span><a href="https://url.us.m.mimecastprotect.com/s/gYX5CkRVZgtkknDEuVhmcGHXzh?domain=parabilismed.com/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">www.parabilismed.com</span></span></a><span data-contrast="none">&nbsp;or follow us on&nbsp;</span><a href="https://url.us.m.mimecastprotect.com/s/7qd3ClYV50H11oWrFyinczUQak?domain=linkedin.com"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">LinkedIn</span></span></a><span data-contrast="none">.</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p> <p><strong>What’s the opportunity?</strong></p> <p>The Quality Systems Manager at Parabilis Medicines is responsible for implementing and maintaining the company’s quality management system (QMS) to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH, etc.) and internal standards. The role sits at the center of compliance, operations and continuous improvement and is a vital partner for all GxP functions in the organization.</p> <p><strong>Key responsibilites:&nbsp;</strong></p> <p>Manage Core Quality Management System (QMS) Elements</p> <ul> <li>Document Control: Manage the lifecycle of GxP documents to ensure compliance with regulations and internal procedures. This includes but is not limited to formatting, routing workflows, managing metadata, reviewing, approving and making documents effective.</li> <li>Quality Events: Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations.</li> <li>Inspection Readiness: Support all inspection readiness initiatives including but not limited to self-inspections and regulatory inspections.</li> <li>Management Review: Support the tracking and reporting of quality KPIs (e.g., deviation closure time, audit findings, etc.) and assist in the preparation of slides, meeting coordination and presentation of quality trends to senior leadership.</li> <li>Supplier Management: Support qualification and approval activities of external suppliers.</li> <li>Training Administration: Manage training requirements, curricula and learner roles in the company Learning Management System (LMS). Collaborate with process owners to ensure that procedures and other training material are assigned appropriately. Provide training metrics to assist in on time training completion.</li> </ul> <p><strong>What you’ll need to be successful:</strong></p> <ul> <li>Minimum education: Bachelor’s degree in life sciences or equivalent</li> <li>6+ years of industry experience with hands-on quality systems work and knowledge of regulatory requirements across various compliance categories (GMP, GCP, etc.).</li> <li>Specific qualifications: Proficient in Veeva electronic Quality Management System including documentation, quality events and training.</li> <li>Skilled in data integrity principles.</li> <li>Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus</li> <li>Remote but able to attend in-person meetings if applicable.</li> </ul> <p><strong>Core Values</strong></p> <p>Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.</p> <ul> <li><strong>Growth-Minded</strong>. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.</li> <li><strong>In(ter)dependent.</strong> We are fiercely&nbsp;<em>independent</em>&nbsp;as a leader in&nbsp;defying the limitations of current therapeutic modalities, and&nbsp;<em>interdependent</em> as a team as we&nbsp;work collaboratively to shift&nbsp;drug discovery paradigms and provide patients with better treatment options.</li> <li><strong>Patient-focused. </strong>We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.</li> <li><strong>All-In. </strong>We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.</li> </ul> <p><span style="font-weight: 400;">The base salary range for this position is$125,000-$155,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive<strong> </strong>benefits designed to support our employees’ overall well-being.</span></p> <p><span style="font-weight: 400;">As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.</span></p> <p><span style="font-weight: 400;"><span style="font-weight: 300;">30 Acorn Park Drive&nbsp; &nbsp; |&nbsp; &nbsp; &nbsp;Cambridge, MA 02140&nbsp; &nbsp; |&nbsp; &nbsp; www.parabilismed.com</span></span></p>