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Compliance Consultant (GMP Auditor, QMS)

Compliance Consultant (GMP Auditor, QMS)

ProPharmaRaleigh, NC, US
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Overview

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Responsibilities

  • Represent the company as a subject matter expert (SME) in assigned areas of QA and GMP regulatory and compliance.
  • Stay up-to-date with regulatory and technological changes in the QA and GMP compliance field.
  • Contribute as a critical team member to the implementation and successful execution of risk-based and phase-appropriate GMP projects.
  • Participate in the business development process as a SME and identify scope and effort required to address client needs.
  • Support marketing efforts by promoting QA and GMP services through presentations and development of social media content and blogs.
  • Promote continual improvement regarding customer satisfaction.

Qualifications

Necessary Skills And Abilities

  • Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.
  • High-level expertise in GMP systems and the ability to provide independent consultation based on prior experience and system knowledge.
  • Ability to earn and maintain a client's confidence through planning, organizing, controlling, and directing a project.
  • Willingness and ability to travel as required.
  • Ability to interact professionally and positively with clients and co-workers through strong interpersonal and communication skills.
  • Effective written and oral communication skills; ability to write, type, express and exchange ideas; ability to convey information accurately in English.
  • Educational Requirements

  • Bachelor's degree, or similar college degree, in a scientific discipline.
  • A graduate degree (MSc / PhD) in a scientific discipline is preferred.
  • Experience Requirements

  • Minimum 5 years relevant experience in quality assurance and regulatory GxP compliance.
  • Minimum 3 years managing a technology business or business unit or CQA or GMP SME lead is preferred.
  • Minimum 5 years experience conducting GMP audits.
  • We 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.

    ProPharma Group does not accept unsolicited resumes from recruiters / third parties. Please, no phone calls or emails to anyone regarding this posting.

    J-18808-Ljbffr

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    Compliance Auditor • Raleigh, NC, US

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