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Manager, Software Validation

Location: 

Allendale, NJ, US

Req ID:  690
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

 

Position Summary:

 

This position is responsible for will developing, maintaining, and executing Edgewell Computer Software Validation (CSV) strategies as per the established procedures governing Edgewell’s approach to the overall CSV effort, with the goal of maintaining compliance to the applicable internal and regulatory standards governing software validation.
 

Accountabilities

 

  • Execution of governing CVS policies/procedures.
  • Manage the validation of software systems in collaboration with the business partners to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives.
  • Management of the validation team involved in the execution and development of validation documentation, test execution and system maintenance.
  • Serve as the Validation point of contact for all CSV projects/activities.
  • Actively partner with the End Users, IT and Quality in the selection process of all new Solutions introduced at Edgewell, engaging the projects at an early stage of the process to ensure CSV compliance and that the solution of choice is fit for use and purpose.
  • Generation or oversight of CSV protocols for enterprise-level, manufacturing and laboratory systems.
  • Ensure systems & processes are compliant & meet regulatory & business requirements.
  • Serve as CSV Subject Matter Expert (SME) for all client-related issues/concerns dealing with CFR Part 11 compliance and data integrity.
  • Work with the business, IT and Quality to find solutions for the remediation of identified CSV compliance gaps through the appropriate investigative, corrective and preventive mechanisms.  
  • Provide supervision of Edgewell Validation resources.
  • Support regulatory and internal inspections for impacted systems supporting Edgewell’s Quality Management System.
  • Work with IT, and Quality Assurance to ensure alignment in execution of validation activities to achieve an agreed upon state of control for computer systems and infrastructure
  • Lead efforts to enhance and make the testing process more efficient.
  • Develop, write and manage the execution of an overall software test strategy.
  • Oversee the design and implementation of validation procedures, test plans, and test cases.
  • Any other duties and responsibilities as assigned.

 

Required Education, Skills and Experience

  • Bachelor’s degree in engineering, science; (or 15+ yrs. of equivalent work and educational experience within the Software Validation arena)
  • 5-10 years’ experience in a management validation role with responsibility for computer validation
  • 3-5 years leadership both in developing high performing teams but also leading projects
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications.
  • Knowledgeable of FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle. (21 CFR Part 11, Annex 11, 21 CFR Parts 210/211, ISO 13485 and GAMP 5)
  • Experience in the validation of cloud base enterprise systems.
  • Knowledge of quality business practices and business development.
  • Excellent multi-tasking, analytical, organizational and leadership skills.

Ability to troubleshoot, identify root cause and systematically resolve problems.

 

 

 

Working Relationships

 

  • Key relationships internally will include working with key stakeholders, including the business, Information Technology partners across multiple sites.

 

Work Environment

  • Some travel is required.

 

 

 

Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.

 

 


Nearest Major Market: New Jersey