Compliance Manager

Introduction

qPharmetra provides clinical pharmacology and pharmacometrics expertise to clients in pursuit of new medicines to treat unmet patient need. We are located in the US and Europe and provide career opportunities for individuals that share our commitment to help our clients make better decisions for developing medicines to improve the lives of patients. At qPharmetra you will have the opportunity to contribute to a fantastic team of international colleagues with diverse backgrounds and seniority.

We are looking for an experienced Compliance Manager to join our team.

In this role you will be responsible for developing and implementing compliance policies, procedures, and controls to ensure that the organization is following relevant laws and regulations.

Responsibilities

  • Strategy
    • Develop the strategy for preventing violations of legal rules, regulatory guidelines and internal policies and procedures
    • Improve current strategies if necessary
    • Proactively advise the senior management team on the emerging regulatory trends that are most relevant to the company’s goals and evolving needs
    • Help determine capital investment parameters, priorities, and risks for enterprise-wide compliance initiatives to maximize the return on investment
    • Define and maintain overview of internal and external stakeholder categories and their compliance demands
    • Define international standards of interest to adhere to and/or comply with, to meet stakeholder demands
  • Leadership
    • Collaborate and maintain continuous communication with HR, CIO, COO, IT vendors and other relevant external parties
    • Monitor external trends and events relevant to the compliance area
    • Develop a thorough understanding of the IT and information security compliance to enable independent execution of compliance evaluation tasks associated with these areas
    • Implement the most appropriate and effective compliance organizational design to support and engage with the business
    • Ensure, on an ongoing basis, that current and planned compliance solutions are aligned with company business objectives
    • Prepare and monitor compliance operational budgets that meet prevailing objectives and constraints
    • Participate in networking activities and relevant conferences within the compliance area
  • Compliance Operations
    • Day-to-day management of the compliance system
    • Evaluate the efficiency of controls
    • Conducting internal reviews and audits
    • Identify risks or non-conformity issues
    • Ensuring incidents are actioned appropriately
    • Design, improve and implement productive and efficient company policies and procedures as well as vendor qualification documents
    • Revise procedures, reports etc. periodically
    • Identify compliance issues and necessary training
    • Create reports for senior management and external stakeholders
    • Lead and be primary person conducting activities associated with replying to compliance questionnaires
    • Lead and be the primary person conducting activities associated with external audits of qPharmetra’s internal controls
    • Lead and execute audits of vendor controls

Qualifications

  • Minimum 4 years of experience in a compliance/operations-based role
  • Knowledge and understanding of the drug development industry’s regulations and best practices, specifically GCP, ICH Guidelines, 21 CFR Part 11, and GDPR
  • Hands-on experience with a variety of reporting operations and procedures
  • Good organizational and time-management skills
  • Ability to multi-task
  • Strong interpersonal and communication skills, both oral and written
  • Critical-thinker and problem-solver
  • BA in law, finance, business administration or similar related field
  • Can create a clear strategic vision for compliance that supports business objectives and can execute on that vision
  • Able to work collaboratively with diverse leaders, communicate a compliance vision and strategy across all levels of the organization, and build consensus around key initiatives and projects
  • Experience of information security compliance is a plus

If you want to join us please send your resumé to .


qPharmetra does not accept unrequested help from recruiters for this job opening. Resumes (in whatever shape or form) that are sent by recruiters to qPharmetra or any employee of qPharmetra without a written assignment of a recruiter, will not constitute a basis for any claim or any form of compensation to the recruiter payable by qPharmetra.

Meet the experts

We are over 20 scientists with extensive experience located in the US and Europe. We work closely together and share knowledge to help our clients make better decisions.

Publications

Our succes in integrating information into models that generate unique insights, allowing executives to make better drug development decisions, is reflected in our gold-standard research publications.

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Phone (US)
+1 919 324 5670
Phone (EU)
+46 70722 90 35
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