{"id":2832662,"url":"https://alion.io/job/lonza-associate-director-quality-assurance","title":"Associate Director, Quality Assurance","company":{"id":679681,"name":"Lonza","domain":"lonza.com","url":"https://alion.io/company/lonza","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":36,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-10-21T05:46:15Z"}},"role":"HR","role_family":"HR","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Walkersville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":168000,"max":196000,"currency":"USD","period":"year","gross":null,"usd_annual":196000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-10-21T05:18:54Z","board_verified":true,"closed_at":null,"days_open":37,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":37},"description":"Associate Director, Quality Assurance\nLocation: This position is based in our Walkersville, MD office. The typical work schedule is Monday through Friday, 8:00 AM-5:00 PM EST.\nWhat you will get:\nThe full-time base annual salary for this position is expected to range between $168,000 to $196,000. In addition, below you will find a comprehensive summary of the benefits package we offer:\nPerformance-related bonus.\n\nMedical, dental and vision insurance.\n\n401(k) matching plan.\n\nLife insurance, as well as short-term and long-term disability insurance.\n\nEmployee assistance programs.\n\nPaid time off (PTO).\n\nCompensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.\nWhat will you do:\nThe Associate Director, Quality Assurance is responsible for leadership and oversight of the site Quality Systems organization. This role ensures the effectiveness, compliance, and continuous improvement of key Quality Management System (QMS) processes supporting medical device, media, and LAL manufacturing operations. The position leads a team responsible for the ownership and execution of change controls, deviations, investigations, CAPAs, complaints, effectiveness checks, compliance monitoring, and quality metrics. The Associate Director will work cross-functionally with Quality, Manufacturing, Technical Operations, Regulatory Affairs, and site leadership to maintain a robust and inspection-ready quality system.\nLead and develop a team of approximately 5-10 quality professionals responsible for Quality Systems processes and compliance activities.\n\nProvide strategic and operational oversight for Change Control, Deviations, Investigations, CAPA, Customer Complaints, Effectiveness Checks, Document Control, Label Control, and related quality system processes.\n\nEnsure Quality System records are initiated, investigated, reviewed, and closed in a timely manner with appropriate risk assessments, root cause determination, and documented evidence.\n\nServe as process owner for key Quality Systems programs and drive standardization, compliance, and continuous improvement across the site.\n\nMonitor and trend quality metrics, identify emerging risks or compliance concerns, and communicate findings to Quality and Site Leadership.\n\nEstablish governance and escalation processes for critical quality events, ensuring appropriate management visibility and timely resolution.\n\nPartner with site functional leaders to assess process performance, implement corrective actions, and strengthen overall quality system effectiveness.\n\nProvide coaching, mentoring, and technical guidance to support thorough investigations, robust CAPAs, and sustainable remediation plans.\n\nSupport internal audits, customer audits, and regulatory inspections, including the development and execution of responses and corrective action plans.\n\nMaintain a culture of quality, compliance, accountability, and continuous improvement throughout the organization.\n\nDevelop departmental objectives, resource plans, and budgets to support current operations and future business growth.\n\nReview high-risk deviations, investigations, complaints, and change controls, escalating significant quality risks to site leadership as appropriate.\n\nPerform other duties as assigned.\n\nWhat we are looking for:\nBachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, or related discipline; advanced degree preferred.\n\n10+ years of Quality Assurance experience within pharmaceutical, biotechnology, medical device, cell therapy, or other regulated manufacturing environments.\n\n5+ years of leadership experience managing Quality Systems functions and high-performing teams.\n\nDemonstrated expertise with Quality Management Systems, including Change Control, Deviations, Investigations, CAPA, Customer Complaints, Risk Management, and Compliance programs.\n\nStrong understanding of FDA, EU GMP, ISO 13485, and applicable cGMP/cGxP regulations.\n\nExperience serving as a Quality Systems process owner and driving quality system improvements within a complex manufacturing environment.\n\nProven ability to analyze quality metrics and trends, identify compliance risks, and implement sustainable solutions.\n\nExperience supporting regulatory inspections, customer audits, and responses to regulatory observations.\n\nProficiency with electronic Quality Management Systems such as TrackWise, MODA, SAP, and other validated business systems.\n\nStrong communication and stakeholder management skills with the ability to influence leaders across multiple functions and organizational levels.\n\nDemonstrated ability to lead organizational change, build high-performing teams, and foster a culture of continuous improvement.\n\nAbout Lonza\nAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.\nInnovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.\nReady to shape the future of life sciences? Apply now.","description_format":"text","description_chars":5729,"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":["Life insurance","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-19T03:51:56Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.456,"p_room":0.35,"age_days":37,"expected_fill_days":11,"reasons":["conf:0","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":196000,"is_top_pay":false},"html_url":"https://alion.io/job/lonza-associate-director-quality-assurance","json_url":"https://alion.io/job/lonza-associate-director-quality-assurance.json","meta":{"generated_at":"2026-10-21T13:49:05Z","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":19634,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":679681},"rest":"https://alion.io/mcp/rest/get_company?id=679681"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flonza-associate-director-quality-assurance"},{"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%2Flonza-associate-director-quality-assurance"},{"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%2Flonza-associate-director-quality-assurance"},{"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/lonza-associate-director-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flonza-associate-director-quality-assurance"}]}