Senior Manager, QA - Clinical

<h3>The Opportunity</h3> <p><span data-contrast="auto">The Quality Assurance team is seeking a Senior Manager, Clinical Quality Assurance to play a key role in connecting clinical development timelines with essential regulatory and CGP requirements.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">In this role, Quality is a proactive partner, not just a checkpoint. You will contribute to how clinical studies are designed, executed, and documented by applying your expertise in ICH‑GCP and risk-based, quality-by-design principles.  As a core member of cross‑functional teams, including Clinical Sciences, Clinical Operations, and Regulatory Affairs, you will help ensure every study is conducted to the highest global standards.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">If you enjoy collaborative problem‑solving, anticipating compliance risks before they surface, and guiding teams through complex international expectations, this role offers the opportunity to make a meaningful impact. You will help strengthen a culture where patient safety, data integrity, and operational excellence guide our decisions.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">This position reports to the Associate Director, Quality Assurance – Clinical.</span><span data-ccp-props="{}"> </span></p> <h3>The Impact You’ll Have</h3> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">As the Senior Manager, Clinical Quality Assurance, you will serve as a strategic partner and senior individual contributor responsible for strengthening the integrity of our clinical portfolio</span><span data-ccp-parastyle="Normal (Web)">.  </span><span data-ccp-parastyle="Normal (Web)">You will drive proactive quality, risk-based oversight, and regulatory readiness across global studies through the following areas:</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <p><strong><span data-contrast="auto">Strategic Study Leadership (Daily / Ongoing)</span></strong><span data-ccp-props="{}"> </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">Serve as the CQA representative on Study Execution Teams.</span></li> <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">Identify quality and compliance risks during protocol and study planning.<span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Lead or support RCA discussions and recommend effective CAPAs.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul> <p><strong><span data-contrast="auto">Risk Based Audits & Vendor Oversight (Monthly / Quarterly)</span></strong><span data-ccp-props="{"335557856":16777215}"> </span></p> <ul> <li><span data-contrast="auto">Plan and conduct investigator site, CRO, and internal process audits.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Prepare clear audit reports that inform study and vendor decisions.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Act as the quality point of contact for CRO partners and support ongoing governance.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul> <p><strong><span data-contrast="auto">Inspection Readiness & Regulatory Alignment (Project Based)</span></strong><span data-ccp-props="{"335557856":16777215}"> </span></p> <ul> <li><span data-contrast="auto">Support mock inspections and global health authority readiness activities.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Prepare SMEs for FDA, EMA, and other inspections.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Monitor evolving ICH E6(R3)/GCP guidance and update procedures accordingly.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul> <p><strong><span data-contrast="auto">Mentorship & Quality Systems (Continuous)</span></strong><span data-ccp-props="{"335557856":16777215}"> </span></p> <ul> <li><span data-contrast="auto">Provide technical guidance to junior team members, contractors, and third party auditors.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> <li><span data-contrast="auto">Contribute to the development and optimization of Clinical and Quality SOPs and quality metrics.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul> <p><strong><span data-contrast="auto">Budget & Resource Planning</span></strong><span data-ccp-props="{"335557856":16777215}"> </span></p> <ul> <li><span data-contrast="auto">Support QA leadership in planning audit resources based on study risk and geographic needs.</span><span data-ccp-props="{"335557856":16777215}"> </span></li> </ul> <h3>What We’re Looking For</h3> <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="12" data-aria-level="1"><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)"><span class="TextRun SCXW152000565 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW152000565 BCX8" data-ccp-parastyle="Normal (Web)">Bachelor’s degree in life sciences or related field with 10+ years of industry experience, or an advanced degree with 7+ years of relevant experience</span></span><span class="EOP SCXW152000565 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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="Normal (Web)">5+ years of direct experience in Clinical Quality Assurance or Clinical Compliance</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW182990102 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW182990102 BCX8" data-ccp-parastyle="Normal (Web)">Proven experience leading Phase 1-III GCP audits and </span><span class="NormalTextRun SCXW182990102 BCX8" data-ccp-parastyle="Normal (Web)">executing risk‑based audit plans</span></span><span class="EOP SCXW182990102 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW44771415 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW44771415 BCX8" data-ccp-parastyle="Normal (Web)">Hands-on experience with QMS and eTMF systems (e.g., </span><span class="NormalTextRun CommentStart SCXW44771415 BCX8" data-ccp-parastyle="Normal (Web)">Veeva Vault</span><span class="NormalTextRun SCXW44771415 BCX8" data-ccp-parastyle="Normal (Web)">)</span></span><span class="EOP SCXW44771415 BCX8" data-ccp-props="{"134233117":true,"134233118":true}"> </span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW176609181 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW176609181 BCX8" data-ccp-parastyle="Normal (Web)">Strong ability to interpret ICH E6(R3) and 21 CFR Part 11 and translate them into practical quality strategies</span></span><span class="EOP SCXW176609181 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW236593243 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)">Demonstrated </span><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)">expertise</span><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)"> in Root Cause Analysis (RCA) </span></span><span class="TextRun SCXW236593243 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)">to </span><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)">development</span><span class="NormalTextRun SCXW236593243 BCX8" data-ccp-parastyle="Normal (Web)"> of sustainable CAPAs</span></span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="NormalTextRun SCXW93231477 BCX8" data-ccp-parastyle="Normal (Web)">Comprehensive knowledge of global GCP </span><span class="NormalTextRun SCXW93231477 BCX8" data-ccp-parastyle="Normal (Web)">regulations;</span><span class="NormalTextRun SCXW93231477 BCX8" data-ccp-parastyle="Normal (Web)"> recognized as subject matter resource for cross-functional teams</span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW139842106 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW139842106 BCX8" data-ccp-parastyle="Normal (Web)">Strong collaboration and communication skills; able to influence partners while upholding quality expectations</span></span><span class="EOP SCXW139842106 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="20" 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-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"><span class="TextRun SCXW187684301 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW187684301 BCX8" data-ccp-parastyle="Normal (Web)">Comfortable navigating ambiguity and applying sound judgment in complex clinical situations</span></span><span class="EOP SCXW187684301 BCX8" data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></span></li> </ul> <p><strong><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Additional Valued Skills and Experiences:</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <p><em><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">While the following are desired, they are not required</span><span data-ccp-parastyle="Normal (Web)">.  </span><span data-ccp-parastyle="Normal (Web)">We encourage you to apply even if you do not meet </span><span data-ccp-parastyle="Normal (Web)">every qualification</span><span data-ccp-parastyle="Normal (Web)"> listed.</span></span></em><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="19" 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="Normal (Web)">Professional certifications such as RQAP‑GCP, ASQ‑CQA</span><span data-ccp-parastyle="Normal (Web)">, Six</span><span data-ccp-parastyle="Normal (Web)"> Sigma. </span></span></li> <li data-leveltext="" data-font="Symbol" data-listid="19" 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-ccp-parastyle="Normal (Web)">Experience supporting Nephrology or Small Molecule clinical programs.</span></li> <li data-leveltext="" data-font="Symbol" data-listid="19" 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-ccp-parastyle="Normal (Web)">Prior experience in Clinical Operations</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></li> </ul> <p><strong><em>This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week.</em></strong></p> <p> </p> <h3><strong>About Maze Therapeutics</strong></h3> <p>Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.</p> <h3><strong>Our People</strong></h3> <p>Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. </p> <h3><strong>Our Core Values</strong></h3> <p><span style="color: rgb(233, 104, 82);"><strong>Further Together</strong></span> – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission. </p> <p><span style="color: rgb(132, 39, 107);"><strong>Impact Obsessed</strong></span> – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.</p> <p><span style="color: rgb(58, 193, 205);"><strong>Stand True</strong></span> – Our integrity is foundational; it guides us no matter the obstacle.</p> <hr> <p>The expected annual salary range for employees located in the San Francisco Bay Area is <span class="TextRun SCXW115636322 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW115636322 BCX8" data-ccp-parastyle="Normal (Web)">$177,000 - $217,000</span></span> . Additionally, this position is eligible for an annual performance bonus.</p> <p>Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.</p> <p>Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.</p> <p> </p> <p><span style="color: rgb(255, 255, 255);"><em>#LI-Hybrid</em></span></p>