{"id":2937010,"url":"https://alion.io/job/gsk-operational-quality-specialist-mes","title":"Operational Quality Specialist - MES","company":{"id":6649,"name":"GSK","domain":"gsk.com","url":"https://alion.io/company/gsk","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":62,"ghost_share":0,"stale_share":0.742,"repost_share":0.016,"time_to_fill_p50_days":16,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Operations","role_family":"Operations","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Marietta, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":89000,"max_usd":178000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2162},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Incident Management","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-08-26T00:00:00Z","employer_posted_date":"2026-08-26","last_verified_at":"2026-11-05T05:08:14Z","board_verified":true,"closed_at":null,"days_open":71,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":71},"description":"Business Introduction:\nWe manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.\nWe need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.\nPosition Summary:\nTo ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Directly support Operational through development, review, and approval of MES related design, implementation and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing. You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands-on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.\nResponsibilities:\nProvide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.\n\nEnsure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.\n\nReview eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation\n\nReview and approve creation and/or updates to master data:\n\nEquipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi\n\nReview and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi\n\nApproval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi\n\nGxP, DI, Business Continuity Risk Assessments, PI inventory\n\nIO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable). Audit Trail Reviews\n\nDevelop/Approve MES LSOPs and associated child documents\n\nProvide review, initial impact approval, and final approval of devations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.\n\nRole model the GPS standards and foster a ‘Quality Starts With Me’ culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.\n\nPerform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.\n\nLead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow-up. Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.\n\nSupport inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.\n\nMonitor MES-related quality KPIs and trends and recommend process or system improvements.\n\nBasic Qualifications:\nBachelor’s degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.\n\nMinimum 3 years' experience in regulated industry preferably in Quality Assurance.\n\nMust have prior MES implementation experience.\n\nRequires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.\n\nExperienced with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.\n\nTraining and work experience in DMAIC root cause analysis methodology.\n\nMust have 1 + year of hands-on experience with Good Manufacturing Practices and Good Documentation Practices.\n\n Preferred Qualifications:\nExperience in biologics manufacturing preferred.\n\nFamiliarity with electronic records guidance such as 21 CFR Part 11 or Annex 11.\n\nHands-on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks.\n\nExperience with LIMS, electronic batch records, or other digital manufacturing solutions. raining and work experience in DMAIC root cause analysis methodology.\n\nWell-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts with Me’ culture and work with a spirit of continuous improvement.\n\nAbility to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions.\n\nTime management skills and ability to prioritize and respond to operational needs/issues within high paced environment.\n\nTraining or experience in root cause analysis and CAPA methodologies. Demonstrated ability to influence cross-functional teams and coach colleagues on quality and data practices.\n\nSkills\nData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.\nWhy GSK?\nUniting science, technology and talent to get ahead of disease together.\nGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.\nPeople and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.\nIf you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - \nGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.\nImportant notice to Employment businesses/ Agencies\nGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.\nPlease note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/","description_format":"text","description_chars":9848,"description_truncated":false,"requirements":{"experience_years_min":3,"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":false,"industries":["Prescription Drugs","Vaccines","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T16:21:09Z"}],"visa":[],"liveness":{"score":7,"band":"cold","label":"Long shot","p_open":1,"p_active":0.256,"p_room":0.28,"age_days":71,"expected_fill_days":16,"reasons":["conf:0","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/gsk-operational-quality-specialist-mes","json_url":"https://alion.io/job/gsk-operational-quality-specialist-mes.json","meta":{"generated_at":"2026-11-05T14:09:17Z","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":18247,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":6649},"rest":"https://alion.io/mcp/rest/get_company?id=6649"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgsk-operational-quality-specialist-mes"},{"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%2Fgsk-operational-quality-specialist-mes"},{"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%2Fgsk-operational-quality-specialist-mes"},{"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/gsk-operational-quality-specialist-mes\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgsk-operational-quality-specialist-mes"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2937010}},{"tool":"search_jobs","arguments":{"company":"gsk.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2937010},"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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