Senior Manager, Product Validation (Remote)

Job Description

This position is responsible for leading the execution of the system release and validation process across all regulated systems.  They will be responsible for managing the Computer Systems Validation process as set out by Pharma Service across all systems deemed covered by the FDA 21CFR Part 11 regulations.  They will be responsible for ensuring that all covered systems maintain a validated state throughout their life cycle, ensuring the Master Validation Record for each system is created and updated in compliance with Pharma Services – Technology & Systems Policies and SOPs.

Responsibilities:

Lead each validation effort from the point the Intent to Validate Memo is signed through obtaining the Release to Production Memo is signed. This will include, but is not limited to:

• Execute the System Validation Risk Assessment and obtain Memo of Intent to Validate.
• Create and maintain the system Master Validation Record.
• Work with the Project Director to create LOEs and Product Release Plans for new and updated system releases.
• Provide guidance on resource planning for Product Release Plans.
• Work with the Sr. Director of Technology & Systems to define validation strategy and document in the system Validation Master Plan.
• Ensure that each required validation artifact is authored and constructed according to the strategy identified in the Validation Master Plan and in compliance with Pharma Services, Technology and Systems policies and SOPs.
• For bespoke, custom systems, aid in the gathering and maintenance of backlog items for future releases, and in the selection of appropriate features to be selected for the next system iteration.
• For purchased, Configurable Off The Shelf (COTS) systems, aid in the identification and selection of systems or utilities that can be validated and maintained in compliance with 21CFR Part 11 regulations.
• Investigate, report and remediate, where appropriate, reported system deficiencies in compliance with the Pharma Services – Issue Management Program
• Aid in the creation and maintenance of all Pharma Services Technology and Systems Policies, Standard Operating Procedures, Work Instructions, Forms and Templates, needed to validate and maintain a validated state in compliance with FDA 21CFR Part 11 regulations.
• Work with Pharma Services QA to ensure that all documentation is in compliance with overall Pharma Services Quality Management System.
• Assist in Customer capability audits around 21 CFR Part 11 process and documentation.
• Other duties as assigned

Qualifications:

Required Work Experience: 

• 5+ years of experience in laboratory, biopharma, and/or diagnostic industry delivering and managing regulated systems

Preferred Work Experience: 

• 3+ years of experience in a similar role in a contract research organization or a GCP laboratory with 21CFR Part 11 governed systems

Physical and Mental Requirements: 

• Office work and periodic travel

Knowledge:

• Understanding of Software Life Cycles, particularly agile methodology. Expert user of Microsoft Office. Database structure and query tools such as DBForge.

Skills:

• Critical thinking and problem-solving skills
• Quantitatively inclined
• Strong communications

Required:

• Indirect Leadership responsibility
• Work environment: Remote, able to work with international virtual teams
• Domestic and International travel up to 25%

• A bachelor’s degree or higher or equivalent experience 

• English required

Preferred:

• Master’s Degree or Equivalent

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