26 days old

Senior Manager IT Validation

Patheon
California City, CA 93505
105871BR
Location :
US - California - Carlsbad
:
Job Description

The candidate will independently review, comment and approve validation documentation including specifications, protocols, reports and SOPs with a focus on cGMP impact and validation lifecycle requirements and corporate IT Enterprise solutions. This independent role will lead the ITQA input on validation projects in support of IT delivered Quality Solutions. The candidate will provide direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. The ideal candidate will share ideas, discuss validation approach, communication of best practices, information sharing related to validation lifecycle e.g. Experience in the use of HP Quality center or other automated testing tools is desirable. The candidate will assist the business in areas of document management, IT policies and procedures.

Requirements

  • Advanced knowledge of GxP regulations as they pertain to the life science industry. Knowledge of GAMP is also required in certain instances.
  • Must be able to interpret regulations and apply them to every day working.
  • Must have an advanced understanding of validation lifecycle and all applicable phases including planning, testing, reporting and change control.
  • Implementation of GAMP-5 processes
  • Knowledge of Agile software development processes
  • Development of SOPs, Technical Standards, Qualification/Validation Protocols and Forms
  • Strong knowledge of the business areas supported by IT., (Labs, Manufacturing, Commercial)
  • Required to recognize systems that are inefficient and that require updating.
  • The ability to recommend changes in support of process improvements to the business areas
  • Makes recommendations as to how correct these situations whilst maintaining compliance and meeting the business need.
  • Often required to ‘think out of the box’ in order to offer solutions to validation issues as they pertain to regulatory interpretation
  • Must be able to work in a multi-disciplinary team and act as a leader
  • Participates and has input into project validation plans whilst ensuring compliance with appropriate regulations and company policies.
  • Works with supervisor to develop strategic input
  • Able to review multiple tasks and prioritize appropriately
  • Ability to share technical competencies with others and to apply this knowledge to assist in issue resolution
  • Understanding of the infrastructure qualification process
  • Collaborates with peers in the Enterprise Technical Operations group by input to technical architectural design, for problem definition, analysis, requirements development and implementation for complex to extremely complex systems within the network infrastructure.

Education

  • Bachelor’s Degree in Life Sciences, Computer Science, 8+ years or 15 + years’ experience working in a GLP, GCP, GMP medical device environment or other government regulated environment; or an MS with 6+ years of strong compliance and validation background.

Experience

  • Experience working as a Quality Assurance representative in a GXP regulated environment
  • Experience in SDLC, including qualification, validation and change control
  • Experience developing and delivering training
  • Experience in management and mentoring of staff

Knowledge, Skills, Abilities

  • Ability to clearly communicate at all levels of the organization
  • Experience with system support/system administration
  • Excellent analytical abilities, creative problem-solving skills and strong planning and organizing capabilities
  • Ability to understand both the business and the technical aspects of the applications supported.
  • Experience with validation, training, change management, and/or supplier audits
  • Ability to work well within fast paced, team environment
  • Ability to mentor staff as required
  • Coding and script writing
  • Ability to analyze and propose solutions in the qualification process of infrastructure and services.




If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Categories

Posted: 2019-10-16 Expires: 2019-11-15

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Senior Manager IT Validation

Patheon
California City, CA 93505

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