{"id":954950,"url":"https://alion.io/job/sonothera-associate-director-quality","title":"Associate Director, Quality","company":{"id":688535,"name":"SonoThera","domain":"sonothera.com","url":"https://alion.io/company/sonothera","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"hybrid","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":null,"salary_estimate":{"min_usd":161000,"max_usd":312000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":628},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-14T18:42:08Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-10-22T01:25:37Z","board_verified":true,"closed_at":null,"days_open":37,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":37},"description":"The Role:\nThe Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment. The Associate Director, Quality reports to the Vice President, Head of Regulatory and Quality. This is a full-time hybrid role.\nWhat You Will Do:\nQuality Program Development \nDevelop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP )\nImplement pragmatic quality approaches that balance compliance with operational efficiency\nCreate quality culture and awareness across all organizational levels\nExcellent leadership, communication, and interpersonal skills\nCRO Management & Strategic Partnerships\nServe as the co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities.\nImplement risk-based CRO oversight programs optimized for resource efficiency\nBuild strong working relationships with CRO quality teams to ensure seamless collaboration\nManage CRO performance with emphasis on speed, quality, and value delivery\nQuality Systems & Documentation\nDevelop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP.).\nEnsure proper documentation and record-keeping practices\nLead development of standard operating procedures (SOPs) and work instructions\nMaintain document control and change management processes\nReview key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data.\nTechnical Requirements and Skills: \nTechnical Skills\nDeep understanding of FDA, EMA, & ICH regulatory requirements\nExtensive knowledge of GMP, GLP, and GCP principles\nExperience with quality management systems and quality metrics\nStrong understanding of gene therapy development processes\nExperience with quality auditing and inspection processes\nQualifications\nBachelor’s degree in life sciences or related field required\n10 + years of biotech industry experience\nPrevious startup or small company experience highly preferred\nExperience building quality processes in early-stage development and understanding a fit-for-purpose approach\nMinimum 3-5 years of experience managing CROs and vendor relationships\n Compensation: The salary range for this FTE position is $190, 000 to $220, 000 USD per year. This annual salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location .","description_format":"text","description_chars":3137,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-09-16T04:22:52Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"Filed H-1B visas in the last two years","filings_12m":0,"filings_prev_12m":4,"green_card_filings_12m":0,"median_offered_wage_usd":null,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":37,"band":"fade","label":"Fading","p_open":1,"p_active":0.675,"p_room":0.55,"age_days":36,"expected_fill_days":28,"reasons":["conf:3","win:tail"],"computed_at":"2026-10-21T05:46:15Z"},"pay":null,"html_url":"https://alion.io/job/sonothera-associate-director-quality","json_url":"https://alion.io/job/sonothera-associate-director-quality.json","meta":{"generated_at":"2026-10-22T04:05:57Z","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":4224,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":688535},"rest":"https://alion.io/mcp/rest/get_company?id=688535"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsonothera-associate-director-quality"},{"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%2Fsonothera-associate-director-quality"},{"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%2Fsonothera-associate-director-quality"},{"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/sonothera-associate-director-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsonothera-associate-director-quality"}]}