Information Systems Compliance Manager

Company

Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide theng material for the products Prolacta sells.

Job Summary

The Information Systems (IS) Compliance Manager is responsible for review and approval of quality systems and compliance in all areas of computerized hardware and computer system applications to include applicable website changes for Prolacta. Works closely with IT department and business owners to develop new user functionality and expand existing user functionality of individual systems. This position serves as a resource to department and operations on computer-related quality and regulatory issues in the framework of the SDLC model, applicable Prolacta Standard Operating Procedures, and state and federal regulations (i.e. CFR 21 Part 11 and Part 820).

Primary Duties and Responsibilities

Understand and can provide guidance on quality procedures, safety procedures, IT procedures, cGXP procedures and systems as well as state and federal regulations.

· Provides Quality support and guidance for IT project activities; project initiation, scheduling, high impact projects, ensuring that comprehensive project, quality, and risk documentation is prepared and maintained. Develop and/or review and approve validation documentation as needed.

· Knowledge of cGMP/ICH/FDA regulations with 21 CFR Part 11 and GAMP knowledge

· Full understanding and adherence of Prolacta’s quality system procedures and requirements including change control process and software validation life cycle.

· Perform change control impact assessments.

· Review, recommend, and approve requirements specifications and verification methods, procedures, and results, which are communicated through requirement specifications, analysis, demonstration, inspection, test, and simulation results.

· Ensures adherence to project plans and milestone charts.

· Performs risk assessments and develops risk mitigation and contingency plans throughout the life of the project.

· Leads problem resolution as issues arise.

· Work with assigned teams to identify and resolves conflicts, roadblocks, and issues within the project team(s). Escalates issues appropriately.

· Works with IT and IS Team members to ensure project related documentation is completed according to defined standards.

· Perform technical review and approval of validation protocols, requirements, integration, verification and validation traceability Matrixes as needed.

· Provide independent oversight to validate that the product/system fulfills its intended use when placed in its intended environment (i.e. conforms to the customers functional requirements; and meets the expected safety criteria, quality, and reliability standards).

· Provides training and constructive input to team members.

· Provides GMP compliance guidance to the team for SOP and written standards (e.g., FDA), providing additional information as needed to ensure consistent application of quality processes.

· Collaborate with IT to improve requirements, development and verification processes.

· Act as a liaison between IT and Quality to help trouble-shoot quality related issues.

· Assist and review non-conformance investigations and training.

· Develop and maintain Standard Operating Procedures (SOPs), User Guides, and other relevant application documentation.

· Identify gaps in the validated system and provide/implement solutions to improve workflow and efficiencies.

· Responsible for assessing IT vendor/supplier qualification.

· Manage team metrics.

· Other duties as assigned.

Job Requirements and Qualifications

· Bachelor’s degree in electronic, mechanical, or software engineering, computer science, or related field.

· Experience in multiple validation disciplines including manufacturing process validation, hardware/software system validation, equipment qualification, and facilities validation.

· Experience in participating in regulatory agency inspections and/or internal audits with focus on validation activities.

· Verification and Validation experience using risk-based approach (P-FMEAs, etc).

· Ability to collaborate effectively within multiple discipline teams with the ability to review and understand engineering documentation.

· Experience with reviewing documentation for all internal software application launches.

· Experience with evaluation of system documentation submissions to ensure successful transitions.

· Knowledge of computer environments, standards development, and system life cycle methodology.

· Knowledge of change control process to ensure proper completion of change control life cycle (website change control, hardware change control and software change control).

· Knowledge of regulations as they relate to Quality System Regulations for computerized systems (21 CFR parts 820 and 11). Pharmaceutical, Blood Products, or Biotech industry quality and IT activities preferred.

· Experience/background in blood banking, medical fields (pharmaceutical, hospital, etc.).

· Prior work experience in IT, software quality, development or database management.

· 12-15 years Software Quality Assurance or Engineering (SQA or SQE).

· 7-10 years IT auditing.

· 7-10 years SDLC (Waterfall, Rapid Prototype, Spiral, Agile, etc.).

· 12-15 years overall IT experience (can include experience timeframes from above).

· 7–10 years of work experience within the Pharmaceutical, Biological, or Biotech Industry

· Experience with IT practices (COBIT, ITIL, ISO, SEI, etc.).

· Experience with testing tools (HP ALM, Quality Center, Quick Test Pro, Load Runner, etc.).

· Experience on multi-disciple technical project teams as the validation subject matter expert.

· Experience in highly regulated field (FDA, FAA, DoD, SEC, etc.).

· Strong written communication skills.

· Excellent interpersonal skills to maintain partnerships between Quality and IT and to ensure the lines of communication are professional and congenial.

· Perform vendor/supplier qualifications for IT.

· Must be flexible with hours to accommodate production/business needs.

Other Knowledge, Skills and Abilities

· Computer skills (i.e. MS Word, Excel, PowerPoint, Crystal Reports, Visio,

· Experience in providing management reports and status updates utilizing metrics based reporting.

· Self-motivated initiative with strong organizational, interpersonal, and technical communication skills.

· Effective presentation skills.

· Excellent review and analytical skills with attention to detail.

· 12-15 years relevant experience in validation of COTS and development of Customized software systems.

· Ensures systems meet business and regulatory requirements

· Assesses customer needs and guides in developing options to meet those needs

· Ability to prioritize and successfully manage complex and competing projects

· Works in a fast-paced environment, while meeting client and internal demands under strict deadlines

Work Environment (Location, travel, shift, on-call, etc.)

§ This position supports software and hardware operations, implementation and testing for all Prolacta businesses.

§ FLSA: Exempt

§ Travel – domestic and international

§ Location

City of Industry, CA and Duarte, CA

Direct Reports

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to thisfication. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer. Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.