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.
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
Senior Scientist responsible for planning, allocation, and execution of analytical validation and quality assurance activities within the EGMP Analytical Development team.
Responsibilities
Planning and allocation of routine and non-routine activities for the team
Investigating QMS elements and generating reports
Coordinating with QA and other departments for QC functions
Interacting with clients and project teams
Reviewing in-process, cleaning, intermediate and finished product specifications
Requirements
M Sc / M Pharma (Analytical/General chemistry)
Nice to have: Chromeleon data management application
The Cluster Manager - Environmental Testing is responsible for the strategic, operational and technical management of the Environmental Testing business line in Croatia.
Support BioTechnique’s Quality Control operations by executing microbiological and environmental monitoring activities in a sterile manufacturing setting.
Responsibilities
Execute microbiological and environmental monitoring of product samples, utilities, surfaces, air, and personnel according to SOPs and compendial standards
Conduct disinfectant efficacy testing (DET) and related microbiological assays
Prepare and maintain media, sampling kits, and test solutions per SOPs and compendial requirements
Operate biological safety cabinets and laboratory instrumentation while following aseptic techniques
Perform routine cleaning and sanitization of laboratory spaces and support equipment maintenance and calibration
Prepare process and finished product samples; perform analytical testing using instrumental, wet chemistry procedures, and record results using computerized data systems.
Perform daily process monitoring tests throughout the plant as assigned.
Maintain samples of tested product to confirm test results, if necessary.
Document results of all testing procedures and promptly notify operations of required adjustments.
Enter and report data using a Laboratory Information Management Systems (LIMS).
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