Manufacturing & Quality Analyst (BioTech / Pharma)

Manufacturing, Quality, Controls, Biotech, Pharmaceutical, MES
Full Time
$100,000 - $140,000

Job Description

Manager, Manufacturing & Quality (CMC) Systems

Client will consider candidates at the Analyst Level OR Project Management level

Reporting to the Director IT – ERP, CMC and Corporate Systems, this individual will be responsible for supporting the company's Manufacturing and Quality (CMC) systems.  Some projects may include Supply Chain systems.  This includes both daily support and project leadership of enhancements, upgrades, and future system implementations.  The current system portfolio includes a blend of SaaS and on-premise solutions ranging in complexity from laboratory standalone instrumentation/automated manufacturing equipment to enterprise level eQMS, LIMS, MES and the like. The ideal candidate will have a broad range of experience implementing and supporting systems used in Manufacturing and Automation, Supply Chain, Quality Assurance, Quality Control and Laboratory Instrumentation in the BioTech or Pharmaceutical industry.  They will also have experience managing relationships with both internal Business Partners and external vendors. The position will be either a Sr. Analyst or Manager position based on candidate experience.
Responsibilities (including, but not limited to):

  • Conduct customer requirements and gap analyses
  • Proactively work with Business Partners to scope and identify solutions with business value an ROI
  • Partner with key stakeholders to gather information, ensure consistent data quality, and design business process
  • Serve as the Technical System Owner for assigned systems and applications
  • Working with the Director – ERP, CMC and Corporate Systems, manage the relationship with Business Partners and CMC Departments
  • Act as the Solutions Architect for CMC solutions as needs are identified
  • Lead Project development and implementation efforts working as Project Manager, Vendor Manager and Technical Lead
  • Incorporate all Systems Development Lifecycle compliance deliverables into projects and solutions and manage/author computer systems validation documentation
  • Ensure all solutions are maintained in their Validated State and meet all regulatory compliance requirements (21CFR Part 11, 21CFR 210/211, Data Integrity, etc.)
  • Support internal and external reviews and audits, assisting in providing resolution where needed.
  • Build understanding of CMC business and operational strategies and identify critical metrics required to support thosestrategies.  Identify and implement the tools required to calculate and track those metrics.
  • Partner with Quality Assurance, Quality Control, Manufacturing, and Supply Chain business partners and technology consultants, to ensure consistent practices and industry-leading solutions are in place.

Qualifications:

  • Requires a bachelor's degree in technology or a business-related field with 5+ years relevant and appropriate level experience in BioTech or Pharmaceutical industry, master's degree a plus.
  • Six Sigma Certification a plus
  • Business analyst/software support experience.
  • Minimum 5 years working in an FDA GMP or GLP environment is a must.
  • Detailed knowledge of current Good Manufacturing Practices, Computer System Validation requirements (i.e. 21 CFR Part 11, Annex 11, 21CFR 210/211, etc.) and Data Integrity controls.
  • Experience with computer system testing / IT Quality Assurance practices
  • Prior Experience with multiple of the following or similar manufacturing and laboratory applications:
    • Empower Chromatography Data Management System
    • Unicorn Manufacturing Control System
    • SAP S/4 HANA/ERP
    • Veeva Vault
    • Veeva eQMS
    • LIMS/ELN
    • Standalone laboratory instrumentation
    • Manufacturing Automation Skids
    • Manufacturing Execution Systems (MES)
    • Asset Management/Preventive Maintenance/Calibration Management systems
    • Building Management/Monitoring Systems
    • Environmental Monitoring/Stability Systems
    • Warehouse Automation Systems
  • Familiarity with the principles and practice of system configuration management
  • Proficiency in Microsoft Office Suite, especially Microsoft Word & Excel.
  • Excellent interpersonal, communication/verbal skills and technical written skills
  • Excellent written and oral communication skills to clearly and effectively communicate information to internal and external audiences, client groups, and all levels of management. 
  • Strong analytical thinker, curious mindset and aspiration to overachieve
  • Self-starter with demonstrated ability to design, develop, and automate business processes
  • Independent, motivated, team member with experience in a matrix environment

 

Dice Id : 10124617
Position Id : CMC-AP
Originally Posted : 2 months ago
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