eCompliance Manager - Lincoln, NE


Bringing Solutions That Make Business Better

We are seeking an eCompliance Manager to be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the eCompliance Manager, you will provide strategic and lifecycle support to the deployment of GxP software. You will ensure that software that impacts GxP systems operates within the framework of GxP standards and applicable health authority regulations. You will also provide subject matter guidance and representation for all site initiatives as requested. Additionally, you will: 

  • Stay current and knowledgeable of the latest industry technology, including but not limited to Data Science, Artificial Intelligence and Digital Transformation to support the internal development and process improvements
  • Ensure the site’s policies and procedures for the specification, purchase, development, and implementation of digital applications and GxP systems are ‘fit for purpose’
  • Act as a single point of contact for quality governance regarding the procurement of GxP computerized systems and digital applications and provide subject matter review and approval of key documents for the full life cycle from implementation to retirement
  • Coordinate, enforce, and follow up on all activities which impact the validated status of computerized systems and assist with local electronic compliance issues
  • Provide the necessary subject matter support for all audits
  • Maintain customer service relations and develop and sustain professional relationships that reflect commitment to shared values
  • Foster communication and coordination across the team
  • Support local and global initiatives related to this subject matter (e.g.: Data Integrity)
  • As a Subject Matter Expert (SME) for GxP computerized systems, independently determine and pursue courses of action to obtain desired functional and business objectives
  • Support the qualification lead with the production and maintenance of quality related procedures and material
  • Provide subject matter support to System Owners
  • Maintain the site system register
  • Support Inspection Readiness, in close collaboration with Audit Coordinator(s); provide subject matter related support for follow up and/or remediation actions related to regulatory inspections.

What You’ll Need to be Successful:

  • At least 5 years of experience in the pharmaceutical industry with at least 3 years of experience in medical devices, quality assurance, quality management, or IT governance
  • Bachelor’s degree in computer science, IT, chemical engineering, automation, engineering pharmacy, biology, or related technical field, or equivalent professional experience

Great Additional Skills:

  • Profound knowledge of GxP systems and software and electronic data which impact cGMPs, GLP, GCP, GDP, Eudralex, Code of Federal Regulations and in Data Integrity within computer validation
  • Familiarity with the validation and maintenance of Digital Applications, Enterprise Systems, Process and Distributed Control Systems, Laboratory and Clinical Systems and/or software
  • Good understanding of the key expectations of the guideline documents supplied by FDA & MHRA, PIC/S and ISPE (GAMP)
  • Knowledge of:
    • Quality Management
    • Project Management
    • Audit, e.g. Software Suppliers
    • Software Development Lifecycle
    • Software as a Medical Device (SaMD)
    • Change Control, Deviation and CAPA Management
  • Strong communication and negotiation skills (oral and written) and ability to negotiate and influence ‘best practice’ through positive communication with all business areas
  • Demonstrated proficiency and thorough knowledge of computer system validation (CSV) as defined by health authorities (FDA, EMEA, ICH), industry groups and the QMS
  • Experience in international and multidisciplinary environments
  • Demonstrated attention to detail and organizational skills
  • Commitment to shared values with strong interpersonal and leadership skills
  • Results driven with a strong customer and quality focus
  • Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization
  • Ability to make decisions, evaluate risks and define and execute action plans
  • Ability to propose innovative solutions to solve problems

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.

Posted On: Friday, June 12, 2020

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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.