IT Quality Specialist responsible for validation and quality activities for computerized systems in Roche’s Diagnostic division.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Act as a CSV subject matter expert on project teams
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development
Nice to have: Scrum
Nice to have: SAFe
Nice to have: Product Development Process for Medical Devices
Coordinate and advise on all validation activities on a global/organizational level for each assigned system/project, author and review validation documentation, support system audit inspection readiness, and lead Computerized System Periodic Reviews.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Assess changes to determine potential impact to the validated state of the computerized system
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development methodologies (Scrum and/or SAFe)
Nice to have: Product Development Process (PDP) for Medical Devices
Owns the technical integrity, standardization, and long-term health of the PharmaSuite solution that underpins the Next Generation Manufacturing Execution System.
Compensation
$144,000 - $231,000
Responsibilities
Drive standardization of manufacturing processes across sites
Define and maintain the global MES template
Partner with Technical Services & Manufacturing Technology, Process Engineering, Operations and Quality
Evaluate site requests for deviation from the standard
Establish and sustain the standards for Master Batch Record development
Requirements
Bachelor's degree in IT, Computer Science, Engineering, or equivalent
Support lifecycle management, qualification, and compliance of temperature-controlled equipment and analytical laboratory instrumentation at the Swiftwater, PA site.
Responsibilities
Execute and support temperature mapping and qualification of Controlled Temperature Units (CTUs)
Perform CTU temperature mapping studies using Ellab data loggers
Support development, review, and execution of CTU mapping and qualification protocols
Evaluate mapping data against approved specifications
Support IQ/OQ/PQ activities associated with CTUs
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
Nice to have: 3+ years of experience supporting CTU qualification
Nice to have: Hands-on CTU mapping and qualification experience
Nice to have: Experience performing temperature mapping studies using Ellab data loggers
Nice to have: Experience with logger configuration, placement, deployment, data retrieval, analysis, and troubleshooting
Support lifecycle management, qualification, and compliance of temperature-controlled equipment and analytical laboratory instrumentation at the Swiftwater, PA site.
Responsibilities
Support temperature mapping and qualification of Controlled Temperature Units (CTUs)
Perform CTU temperature mapping studies using Ellab data loggers or comparable systems
Support development and execution of CTU mapping and qualification protocols
Evaluate mapping data against specifications and support investigation of temperature excursions
Support IQ/OQ/PQ activities for CTUs and other equipment
Requirements
Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
Nice to have: 3 years of experience supporting CTU qualification
Nice to have: Experience with HPLC, GC, spectroscopy, dissolution, TOC, conductivity, particle counters, balances, microbiological instrumentation
Nice to have: Experience with computerized laboratory systems and eQMS
Supply Chain Coordinator ensures operational readiness for clinical packaging and supply activities by managing SAP master data, sales orders, and logistics for clinical trials.
Compensation
The anticipated base pay range for this position is: €61,200.00 - €98,210.00
Responsibilities
Create and manage sales and purchase orders in SAP
Maintain and verify material, product and logistics master data
Coordinate product and component transfers to CMOs and between internal and external sites
Follow up proof of delivery for supplies shipped to depots and clinical sites
Coordinate shipments of clinical trial materials to depots and between sites
Project Manager / Scrum Master (CSV & Compliance) to drive the end-to-end delivery of validated computerized system implementations, upgrades, and migrations, balancing traditional project management governance with Scrum Master facilitation under GxP regulations.
Responsibilities
Takes ownership of clearly defined, less complex tasks, smaller projects, or initiatives including validated system implementations, upgrades, and migrations.
Assists in outlining and documenting the scope for larger projects, pinpointing key components (validation scope and GxP impact).
Supports and contributes to the management of minor scope changes.
Maintains and refines the product backlog so that validation and compliance activities are planned alongside functional work.
Applies traditional project management governance including planning, milestone tracking, risk and issue management, and status reporting.
The Manager, Quality Master Data & Documentation Systems provides strategic and operational leadership for quality master data governance, documentation systems, and quality information management processes supporting laboratory, manufacturing, and quality operations at the Rocky Mount site.
Compensation
The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.
Responsibilities
Lead, coach, and develop the Lab Systems Master Data team through clear priorities, workload management, training, performance management, and access to appropriate subject-matter support to ensure consistent execution and sustained team capability.
Provide leadership for quality master data processes and partner with appropriate functions to drive improvements across documentation systems, including gLIMS, rDOCs, QDOCs, SDS/electronic forms, and PDOCs, supporting laboratory operations, batch records, SOPs, controlled documentation, and site compliance requirements.
Partner with Quality Control Laboratories, Environmental Control, Document Systems, and Incoming Material Quality to oversee master data configuration, migration, reporting design, functional verification, and maintenance for products, specifications, methods, parameters, materials, and other data-system elements.
Oversee and coordinate the implementation of master data supporting raw materials, finished products, stability programs, product transfers, new product introductions, compendial updates, process improvements, and other site changes.
The Manager QC Systems and Support provides direct management to Technicians, Associates and Specialists, overseeing daily activities of QC Systems and Support to ensure safety, quality, and performance targets.
Locations (2)
Leiden, South Holland, Netherlands
Utrecht, Utrecht, Netherlands
Responsibilities
Provide direct management of QC Systems and Support team and oversee daily activities
Develop and execute work plan for the team, ensuring safety, quality and performance targets are achieved
Track, trend, and report performance metrics
Author, review, and approve records and technical documents ensuring results are compliant with requirements, corporate guidelines and regulations
Own and evaluate relevant change controls, deviations and CAPAs
Requirements
Bachelor's degree or equivalent, preferably in science
Lead cross-functional system and process improvement projects by defining deliverables, managing priorities, budgets, and timelines, applying change management principles, communicating project status, and escalating significant risks or delays.
Requirements
BA/BS degree with at least 4+ years of experience
Master's degree with at least 2+ years of experience
PhD with 0+ years of experience
Associate's degree with 8 years of experience
High school diploma (or equivalent) and 10 years of relevant experience
IT Quality SpecialistRoche · Pleasanton, US
MES Systems Engineering - Sr. PrincipalLilly · Indianapolis, US