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Government & Compliance Specialist

Employer
Reed Technology and Info Serv Company
Location
Horsham
Salary
Competitive

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LexisNexis Reed Tech has a Governance & Compliance Specialist opening in the Horsham, PA office. The Governance & Compliance Specialist position has responsibilities covering both Governance and Compliance and is expected to perform tasks in either discipline. Partners with Operations and non-Operations departments to develop and implement policies, procedures, processes and practices to ensure compliance to contract requirements, quality standards, security standards, Pharma regulations and other regulatory and company requirements. Assures internal controls are in place and are evaluated for compliance via audits and assessments to minimize risk while effectively and efficiently supporting business goals. Coordinates and verifies the remediation of internal and external audit findings with the responsible business partners.

This position can be REMOTE for the EST or CST time zone.

Accountabilities
  • Participation in the planning, execution and reporting of internal audits/assessments for the QMS (ISO 9000), the ISMS (ISO 27000 and FISMA) and Pharma systems (21 CFR Part 11).
  • Generates corrective actions based on internal audit findings.
  • Assesses the completeness of responses to audit findings to ensure a root cause has been identified and addressed and monitors the implementation and effectiveness of corrective actions to closure.
  • Verification of company training programs for Security, Life Sciences, Development, Operations and Quality.
  • Ensures policies and procedures are documented and updated according to company standards, deadlines are met, approvals obtained, guidelines communicated and followed, and repository / system of record up-to-date.
  • Provides oversight to deliver consistency and quality in compliance work across the organization.
  • Identifies gaps in the design and operating effectiveness of controls and processes, and identifies opportunities for more efficient and effective controls and processes.
  • Ability to interpret regulations and laws and communicate effectively to all levels of the organization.
  • Special projects as requested.
  • Performs other duties as assigned.

Qualifications
  • Bachelor's degree in Business, Organizational Development, Information Technology, Information Security or equivalent.
  • A minimum of 5 years auditing experience in a quality, security and/or regulatory environment.
  • ASQ CQA, Lead Auditor training and/or CISSP.
  • Knowledge of Quality and team related philosophies.
  • Working knowledge of ISO standards (ISO 9000, ISO 27000), Federal standards, regulatory standards, etc.
  • Strong project management and interpersonal skills.
  • Ability to work on multiple assignments, with strong ability to adapt to a dynamic work environment and to prioritize tasks accordingly.
  • Strong analytical, research and problem solving skills with a keen attention to detail.
  • Self-motivated, organized and able to work independently and as part of a team.
  • Working knowledge of computer applications, word processing and spreadsheets.
  • Excellent oral and written communication skills.


LexisNexis, a division of RELX Group, is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. If a qualified individual with a disability or disabled veteran needs a reasonable accommodation to use or access our online system, that individual should please contact or if you are based in the US you may also contact us on 1..

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