{"id":3237044,"url":"https://alion.io/job/genentech-senior-quality-lead","title":"Senior Quality Lead","company":{"id":1757810,"name":"Genentech","domain":"gene.com","url":"https://alion.io/company/gene-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":27,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":21,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":141000,"max":261800,"currency":"USD","period":"year","gross":null,"usd_annual":261800},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-16T00:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-29T19:03:17Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech / Roche!\nIn Pharma Development Quality (PDQ), we strive for confidence in the integrity of our data and processes, agility, and unrivaled transparency with health authorities, patients, and society. Our work provides leadership, know-how, and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates, and global regulated processes.\nThis role supports the Roche/Genentech Organization by developing and delivering Quality Assurance strategies, audits, and conclusions for post approval products, affiliates and processes, based on a risk-based approach. Quality Assurance strategies are based on the Critical to Quality framework, encompassing Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Medical Device, and Computer Systems (CS) requirements.\nThe Opportunity\nWe are seeking an experienced Senior Quality Lead to join the Quality Assurance Programs team. You will bring diverse thinking and technical experience in various Quality disciplines (e.g., GCP, CSV, device).\nNote: This role requires strong level GCP knowledge and will be accountable for the quality assurance aspects and leading/supporting inspections of key molecules. CSV and device are preferred but not the main requirement.\nKey Responsibilities:\nThe Senior Quality Lead is a highly experienced Quality Professional who:\n Designs and delivers Quality Strategies and conclusions for assigned Molecules by applying a risk-based approach based on the Critical to Quality (CtQ) framework. Establish strong partnerships with business stakeholders and independently define the Quality Assurance approach, assessing specific risk areas and proposing strategy modifications.\nDefine and Lead Audits: Define the audits required to deliver the Quality Assurance strategy and lead the development of methodology, including the use of data analytics.Independently perform and lead audits, managing preparation, conduct, presentation, timely reporting of outcomes, and evaluation of actions taken.\nIssue Management: Independently manage complex quality issues, group individual findings into systematic issues for process improvement, and escalate significant issues to PDQ management.\nQuality Conclusion and Stakeholder Communication: Independently draw conclusions on the Quality Positions and ensure appropriate action plans are developed to determine acceptability of evidence of compliance. Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives, including discussions with Legal and Regulatory Affairs.\nPDQ Goals and Initiatives: Contribute and participate in PDQ goals and initiatives to the execution and delivery of PDQ work and the development of PDQ processes.\nHealth Authority Inspections: Lead and support regulatory authority inspections.\nMentor and support the development of Quality Leads within the team.\n PDQ Leadership: Contribute to the long-term strategic direction of PDQ, lead departmental or cross-functional compliance projects, and lead the development/revision of PDQ processes and procedures (SOPs, Work Instructions).\nExpertise and Mentorship: Maintain expert knowledge of GCP/GVP regulations, company policies, and SOPs, assess the impact of new regulations, and act as a trainer and mentor for International and Senior Quality Leads.\nNetworking: Maintain and influence partnerships with senior business stakeholders and PDQ domains. Facilitate cross-functional collaboration to ensure quality standards are met globally.\nWho You Are\nProfessional and Technical Requirements:\nQualifications\nBachelor’s degree or equivalent in scientific or quality-related field. Advanced degree preferred.\nDemonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements.\nProject management experience with proven leadership, mentoring and coaching; Demonstrated ability to effectively organize and execute tasks\nHigh degree of experience, competency, and proven track record leading multiple complex audit types in multiple GCP areas.\nPreferred\nDevice / CSV experience\nStrong digital and data literacy\nExperience hosting, managing and/or supporting regulatory authority inspections; Ability to formulate clear business questions that can be answered with data and utilize data/visualization tools to generate insights.\nProven ability to influence and negotiate effective solutions, drive change, and assimilate new compliance information/trends.\nProven record of working in a global, multicultural matrixed organization (multi-lingual skills desirable).\nThis role is based at our South San Francisco, CA campus. (Onsite presence is preferred, however, a remote option is a possibility.)\nRelocation benefits are not available for this job posting.\nThe expected salary range for this position based on the primary location of South San Francisco, CA is $141,000 - $261,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at link provided below.\nBenefits\nGenentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.\nIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.","description_format":"text","description_chars":6124,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biotechnology","Health Care","Care Coordination & Population Health"],"lifecycle":[{"event":"open","at":"2026-10-25T12:44:42Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 188 · green card filings: 34","filings_12m":188,"filings_prev_12m":151,"green_card_filings_12m":34,"median_offered_wage_usd":150788,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":53,"band":"ok","label":"Likely open","p_open":1,"p_active":0.586,"p_room":0.9,"age_days":13,"expected_fill_days":21,"reasons":["conf:3","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":261800,"is_top_pay":true},"html_url":"https://alion.io/job/genentech-senior-quality-lead","json_url":"https://alion.io/job/genentech-senior-quality-lead.json","meta":{"generated_at":"2026-10-29T22:23:29Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":33110,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1757810},"rest":"https://alion.io/mcp/rest/get_company?id=1757810"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenentech-senior-quality-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgenentech-senior-quality-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgenentech-senior-quality-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/genentech-senior-quality-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenentech-senior-quality-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3237044}},{"tool":"search_jobs","arguments":{"company":"gene.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3237044},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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