{"id":4048735,"url":"https://alion.io/job/vertex-pharmaceuticals-director-device-operational-qa","title":"Director, Device Operational QA","company":{"id":5871,"name":"Vertex Pharmaceuticals","domain":"vrtx.com","url":"https://alion.io/company/vrtx","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":28,"ghost_share":0,"stale_share":0.536,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Leadership","role_family":"Leadership","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":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":184600,"max":277000,"currency":"USD","period":"year","gross":null,"usd_annual":277000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false}],"status":"live","first_seen_at":"2026-11-10T00:00:00Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-11T23:48:07Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Description\nGeneral Summary:\nThe Director, Device Operational QA, is responsible for leading operational quality assurance activities supporting device programs and operations within Quality. This people-management role provides oversight of device quality-system execution, promotes consistent application of quality standards, and serves as a key quality partner to cross-functional stakeholders.\nThe Director leads and develops the Device Operational QA team, manages quality matters and risks, and drives effective, sustainable quality improvements. The role translates functional quality priorities into operational execution while partnering with senior Quality leadership on strategic initiatives, significant quality risks, and organizational priorities.\nThis role requires a minimum of 3 days onsite per week at our Boston, MA office.\nKey Duties and Responsibilities:\nLead, coach, and develop the Device Operational QA team; establish clear priorities, performance expectations, and development plans.\nProvide quality oversight for device operational activities and ensure consistent execution of applicable quality-system processes and standards.\nServe as a key quality partner to cross-functional teams supporting device programs and operations.\nLead assessment, resolution, communication, and escalation of complex operational quality issues and risks.\nEnsure appropriate oversight of quality events, including deviations, nonconformances, investigations, corrective and preventive actions, and change controls, as applicable.\nProvide directions for the review and approval of device-related quality documentation and records that include design controls and risk management, at a minimum.\nMonitor operational quality performance, metrics, trends, and emerging risks; communicate findings and recommendations to Quality leadership and key stakeholders.\nSupport and maintain audit and inspection readiness for device operational activities.\nDrive continual improvement of Device Operational QA processes, procedures, tools, and ways of working.\nPromote risk-based decision-making, accountability, collaboration, and a culture of quality across device operations.\nContribute to functional planning, quality strategy, and capability-building initiatives in partnership with senior Quality leadership.\nEnsure timely execution of quality commitments and appropriate follow-up on actions, decisions, and escalated matters.\nKnowledge and Skills:\nStrong knowledge of Device Operational QA and quality-system principles.\nKnowledge of applicable regulatory and ISO related requirements for operational quality oversight.\nKnowledge of quality risk management and risk-based decision-making.\nKnowledge of quality-event management, including deviations, nonconformances, investigations, CAPA, and change control.\nKnowledge of quality documentation, record review, and approval practices.\nKnowledge of audit and inspection readiness activities.\nAbility to lead, develop, and motivate teams within a quality organization.\nAbility to assess complex quality matters, identify risks and trends, and appropriately escalate issues.\nStrong cross-functional collaboration, stakeholder management, and influencing skills.\nAbility to prioritize competing demands and drive execution in a complex operational environment.\nStrong written, verbal, presentation, and interpersonal communication skills.\nDemonstrated commitment to quality, compliance, continuous improvement, accountability, and sound judgment.\nEducation and Experience:\nTypically requires 12+ years of relevant work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience\nSignificant progressive experience in quality assurance, quality systems, operational quality, manufacturing quality, or a related regulated environment.\nDemonstrated experience supporting design control and risk management activities for medical devices and combination products.\nDemonstrated people-management experience, including coaching, performance management, talent development, and team leadership.\nMinimum bachelor’sdegree in a scientific, engineering, allied health, or related field; advanced degree preferred.\nAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.\nPay Range:\n$184,600 - $277,000Disclosure Statement:\nThe range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.\nAt Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.\nFlex Designation:\nHybrid-Eligible Or On-Site EligibleFlex Eligibility Status:\nIn this Hybrid-Eligible role, you can choose to be designated as: \n1. Hybrid: work remotely up to two days per week; or select\n2. On-Site: work five days per week on-site with ad hoc flexibility.\nNote: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.\n#LI-Hybrid\nCompany Information\nVertex is a global biotechnology company that invests in scientific innovation.\nVertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.\nAny applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ","description_format":"text","description_chars":7054,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cell & Gene Therapy","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-11T01:00:28Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 174 · green card filings: 21","filings_12m":174,"filings_prev_12m":187,"green_card_filings_12m":21,"median_offered_wage_usd":131423,"route":null,"cap_exempt":false,"checked_at":"2026-11-11T07:38:50+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":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":1,"expected_fill_days":38,"reasons":["conf:4","stale_co","win:early","comp:brand"],"computed_at":"2026-11-11T05:49:22Z"},"pay":{"stated_usd_annual":277000,"is_top_pay":true},"html_url":"https://alion.io/job/vertex-pharmaceuticals-director-device-operational-qa","json_url":"https://alion.io/job/vertex-pharmaceuticals-director-device-operational-qa.json","meta":{"generated_at":"2026-11-12T03:53:00Z","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":8465,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":5871},"rest":"https://alion.io/mcp/rest/get_company?id=5871"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvertex-pharmaceuticals-director-device-operational-qa"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fvertex-pharmaceuticals-director-device-operational-qa"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fvertex-pharmaceuticals-director-device-operational-qa"},{"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/vertex-pharmaceuticals-director-device-operational-qa\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvertex-pharmaceuticals-director-device-operational-qa"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4048735}},{"tool":"search_jobs","arguments":{"company":"vrtx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4048735},"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. Docs: https://alion.io/developers"}}