REMOTE Quality Risk Management (QRM) Business Specialist

Company: ProPharma Group
Location: Cambridge
Posted on: August 2, 2022

Job Description:

*Please note when applying this is a six-month remote opportunity
Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Job DescriptionWe are seeking a talented Business Data Analyst to join our Quality Risk Management (QRM) team. This role will be focused in ensuring that the Quality Risk Management (QRM) processes are followed across all Functions and Business Units within the client.One of the key objectives of this role will be focused on gathering QRM files, documenting, analyzing, and determining any gaps with the current QRM processes as part of a CAPA, and liaising/collaborating with stakeholders, subject matter experts, and other team members to align them with the current processes. Also assist in presenting the progress and results of the analysis and deliver QRM training to stakeholders as required.
Job Duties & Responsibilities

• Compile data and develop analysis to support Quality Risk Management file remediation/gap assessments.
• Engage with stakeholders and identify gaps in the Quality Risk Management files in alignment with the current QRM processes.
• Assist in the solution implementation for a CAPA.
• Assist in conducting & establishing trending analysis of the gaps.
• Experience investigating and solving complex technical problems, root cause analysis, and data discrepancies.
• Ability to work collaboratively, raise issues in a productive way, and reach consensus in cross-functional settings.
• Operates independently and/or part of a larger project team to fulfill tasks with little direction, documents results.
• Assist in presenting results of the gap assessments or training when needed.
• Record Meeting Minutes and Decisions when needed.
• Perform other related duties and special projects as required or requested.
  Essential Qualifications
  • 2 to 4 years of experience in biopharmaceutical/pharmaceutical or related industry
  • Experience gathering, owning, and tracking changes to completion
  • Experience in implementing CAPA solution as owner or part of the team
  • Comfortable working independently as an individual contributor and/or part of a larger project team
  • Ability to work in a Global Team structure
  • Familiarity with QMS technologies including Veeva and other E-Systems
  • Expert use of Microsoft Excel and comfortable with large amount of data
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills
  • High attentiveness to detail
    Preferred Qualifications
    • Broad understanding of Quality Risk Management (ICH Q9)
    • Direct experience as CAPA owner
    • Knowledge of cGMPs, GXPs and Quality Systems
    • Expert use of Smartsheet Project Management Tools or ability to rapidly learn
    • Experience in delivering training to a broad audience
    • PMP or Six Sigma Certificate a plusEducationBachelor's degree in chemistry, life sciences, engineering, business, or related field
      Additional InformationWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.This position may include the requirement for occasional travel to client offices.All candidates must be legally eligible to work in the United States.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Cambridge , REMOTE Quality Risk Management (QRM) Business Specialist, Executive , Cambridge, Massachusetts