Company:          Zifo Technologies, Inc.

Location:            245 Main St. Floor 3, Cambridge MA 02142

Position Title:   GxP Consultants

Job Description:

Formulate opinions based on broader industry trends, regulatory requirements and help clients maintain quality application in a GxP state. Perform GxP consulting including Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices. Responsible for implementation and computer System Validation. Meet with stakeholders to understand capability needs, bottlenecks and business priorities. Review the application requirements and determine the GxP needs. Perform risk assessments and regulatory assessments. Work with development and vendor teams to establish the required compliance requirements on the application. Provide inputs on regulatory and quality questions. Engage with Industry Experts and leaders to understand Industry Focus and direction for the future. Understand Industry Regulations and Compliance Requirements from regulatory agencies such as FDA. Develop risk-based validation and regulatory approach to accelerate the drug development and medical device development process. Participate and present in webinars and conferences on Regulatory and Quality. Review the system development process and prepared Risk Assessments, Regulatory Assessments and GxP Assessments. Develop Regulatory and Validation strategy to qualify the application and create the required validation package. Create installation, operational and performance qualification scripts. Establish traceability between the system and regulatory requirements against the qualification scripts. Perform validation testing and create validation summary reports. Create project charter. Define SDLC Methodology (e.g., Waterfall, Agile). Develop change management and risk management strategies. Manage stakeholders and resolve conflicts. Conduct status meetings and status reports. Coordinate with global delivery and validation team from Zifo for validation testing and documentation. Travel and work at client sites as assigned. Anticipated 25% domestic travel. Telecommuting is allowed one day per week. Multiple Positions Available.

Job Requirements:

 Requires a Bachelor’s degree, or foreign equivalent, in Life Sciences, Biotechnology, Information Systems or a related field plus two (2) years of experience in the job offered or a related role. Alternatively, the employer will accept four (4) years of work experience in a related field in lieu of a Bachelors plus two (2) years of described experience.

 Requires two (2) years of experience in the following:

·       Research & Development in clinical and manufacturing areas of pharmaceutical industry.

·       Regulatory Consulting, GxP Consulting and Quality area.

Required two (2) years of experience in the following:

·       Project management and solution implementation.

·       At least one (1) of the following: Drug Development functions, Clinical, or GMP.

·       Waterfall and Agile.

·       Software Testing and Computer System Validation.

·       Regulatory knowledge on 21 CFR part 11, part 58 (GLP), 210 and 11 (GMP), 820 (Quality System Regulations).

·       Risk management techniques such as FMEA, 5 WHYs or similar.

·       Office Productivity Tools such as MS Word, Excel, PowerPoint, or Similar office productivity tools.

·       At least one (1) of the following tools: EDC systems, CTMS systems, LIMS systems, ELN platforms, Quality and Document Management Systems or Analytical Instruments utilized in manufacturing and quality control laboratories.

Travel and work at client sites as assigned. Anticipated 25% domestic travel. Telecommuting is allowed one day per week.

Qualified applicants please: Email resume, referencing  [ZT037], including job history, to: Zifo-US-HR@zifornd.com