{"id":3156261,"url":"https://alion.io/job/bora-pharmaceuticals-qa-manager-manufacturing-quality-operations","title":"QA Manager, Manufacturing Quality Operations","company":{"id":2156158,"name":"Bora Pharmaceuticals","domain":"boracdmo.com","url":"https://alion.io/company/boracdmo","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":7,"ghost_share":0,"stale_share":0.857,"repost_share":0,"time_to_fill_p50_days":35,"computed_at":"2026-10-26T05:57:25Z"}},"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":["Maple Grove, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":108000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-23T14:38:24Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-23T19:52:15Z","board_verified":false,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"About Bora\nBora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.\nJob Summary:\nLeads routine Quality Assurance oversight of commercial pharmaceutical manufacturing and packaging operations. Provides day-to-day GMP support across shop-floor operations, batch-record review, investigations, CAPA execution, complaint support, product disposition, and production escalations. Provides leadership and technical direction to Product Quality Specialists, Quality Associates, and the site Training team. Owns the site GMP training system, including curriculum governance, assignment and completion controls, learning management system administration, qualification programs, training effectiveness, metrics, and inspection support. Ensures continued Quality support after products transition from project mode into steady-state commercial operations and partners across Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, Quality Systems, and functional management. Develops and trends operational, QMS, compliance, supplier-quality, computerized system validation, and training metrics to support management review and continuous improvement.\nEssential Functions:\nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\nProvides direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for Product Quality Specialists, Quality Associates, and the Training team.\nProvides daily QA support and shop-floor or operational Quality coverage for commercial manufacturing and packaging activities.\nOversees review and approval of executed batch records and routine master batch records, logbooks, procedures, and other GMP documentation supporting commercial operations.\nManages manufacturing and packaging deviation records, investigation support, root-cause evaluation, approval, and timely completion in accordance with the Quality Systems process.\nReviews operational CAPAs, monitors follow-up, and verifies that actions are implemented and supported by appropriate evidence.\nAssesses manufacturing and packaging changes for product, process, validation, documentation, and compliance impact and executes change records within the governed change-control process.\nOwns final product disposition for routine commercial products after confirming completion and compliance of applicable batch documentation and quality records.\nManages routine complaint investigation support, including coordination of operational evidence, root-cause analysis, corrective actions, and documentation; Client & Project Quality supports significant client communications and relationship escalations.\nManages production-related Quality escalations and provides timely, risk-based Quality decisions and resource coordination.\nOwns the site GMP training system and directly oversees the Training team, including needs assessment, curriculum governance, training assignment and completion controls, LMS administration, training effectiveness, qualification programs, metrics, and inspection support.\nPartners with functional managers, who remain accountable for ensuring their personnel complete required training and apply training in job performance.\nDevelops, reviews, trends, and reports QMS, compliance, supplier-quality, CSV, and training metrics for management review and continuous improvement.\nDevelops, reviews, and reports operational quality metrics, workload indicators, deviation performance, batch-review status, complaint performance, and disposition status.\nAccepts products into routine commercial Quality support after documented transfer-to-operations readiness criteria are met and maintains ongoing product quality support thereafter.\nCollaborates with Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, and Quality Systems to resolve operational issues and maintain compliance.\nSupports customer and regulatory audits by presenting manufacturing Quality processes, training-system controls, and records; Client & Project Quality coordinates customer-audit hosting and Quality Systems manages inspection infrastructure and system-level responses.\nDrives continuous improvement in operational QA coverage, batch review, investigations, disposition, complaint support, production escalation, and site GMP training processes.\nThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.\n\nMinimum Education, Experience, and Skills\nBachelor's degree (BA/BS) in life sciences, such as chemistry, biology, or a related discipline, or in engineering.\nMinimum of 8 years of Quality Assurance experience in the pharmaceutical or medical device industry.\nMinimum of 2 years of leadership or supervisory experience.\nBroad working knowledge of manufacturing and packaging Quality Assurance, batch-record review, deviation and CAPA execution, complaint investigations, product disposition, regulatory compliance, and GMP training systems.\nExcellent verbal and written communication skills, including the ability to present complex QA and training topics to cross-functional stakeholders, senior leadership, and regulatory auditors.\nDemonstrated leadership and coaching abilities, including experience managing performance and developing multidisciplinary teams.\nStrong knowledge of cGMP regulations, including 21 CFR Parts 210 and 211, and FDA inspection expectations for pharmaceutical manufacturing, packaging, and training systems.\nProven ability to lead operational QA support, investigations, root-cause analysis, CAPA development, batch review, product disposition, complaint support, and production escalations.\nDemonstrated experience with training needs assessment, curriculum governance, learning management system administration, qualification programs, completion controls, and training-effectiveness assessment.\nAbility to develop, trend, interpret, and report QMS, compliance, supplier-quality, computerized system validation, operational, and training metrics.\nStrong analytical, problem-solving, and independent decision-making skills with high attention to detail.\nProficiency with computer applications and quality, documentation, and learning management systems, such as TrackWise, Veeva Vault, or equivalent.\nProven collaboration skills and ability to work effectively across multiple functional teams and with functional managers accountable for employee training completion and application.\nAbility to manage changing priorities and multiple workstreams simultaneously in a fast-paced manufacturing environment.\nPreferred: Quality certification, such as ASQ Certified Quality Auditor or equivalent; working knowledge of EU pharmaceutical regulations and guidelines applicable to manufacturing, documentation, and quality systems.\nSalary Range:\n$108,000-$150,000\nCompensation and Benefits\nWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:\nCompetitive salary and performance-based incentives\n\nComprehensive health coverage including medical, dental, and vision insurance\n\nRetirement savings plans with employer matching contributions\n\nPaid time off\n\nProfessional development opportunities\n\nEmployee wellness programs and resources\n\nEmployee Assistance Program and Mental Health Resources\n\nCore Values\nAt Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.\nBora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.","description_format":"text","description_chars":9381,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development","Retirement plans","Vision insurance","Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-23T14:38:24Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":0.9,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":35,"reasons":["conf:58","win:early"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":false},"html_url":"https://alion.io/job/bora-pharmaceuticals-qa-manager-manufacturing-quality-operations","json_url":"https://alion.io/job/bora-pharmaceuticals-qa-manager-manufacturing-quality-operations.json","meta":{"generated_at":"2026-10-26T20:08:27Z","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":27130,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":2156158},"rest":"https://alion.io/mcp/rest/get_company?id=2156158"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbora-pharmaceuticals-qa-manager-manufacturing-quality-operations"},{"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%2Fbora-pharmaceuticals-qa-manager-manufacturing-quality-operations"},{"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%2Fbora-pharmaceuticals-qa-manager-manufacturing-quality-operations"},{"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/bora-pharmaceuticals-qa-manager-manufacturing-quality-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbora-pharmaceuticals-qa-manager-manufacturing-quality-operations"}]}