Principal CGMP Compliance Consultant

2 weeks ago

Billerica, United States Parexel International Corporation Full time

Parexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing

We currently have a home-based opening on our Team for an experienced CGMP Compliance Expert to join the team as a Principal Consultant. This is an incredible opportunity to assist pharmaceutical and biopharmaceutical companies in driving quality; help our clients manage and prepare for FDA GMP inspections and manage post inspection activities; and work alongside some of the best and most experienced regulatory compliance professionals. A truly phenomenal opportunity to apply your expertise while continuing to develop your career

A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with CGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization.


To be successful a Principal Consultant will have specialized experience in the following:

  • Pre-approval and pre-licensing sterile inspection experience or significant manufacturing facility inspection experience

  • Experience conducting surveillance inspections which have resulted in FDA-483 Inspectional Observations and subsequent OAIs and/or Warning Letters

Experience in the following areas is a plus:

  • Preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters

  • Providing on-site guidance during FDA inspections

  • Preparation for Discussion of CGMP Compliance Matters with FDA

  • Playing an active role in Compliance Remediation strategy and implementation

  • Conducting specialized CGMP training

Education:

  • A Bachelor's degree in a scientific, engineering, or related discipline is required. An advanced degree or equivalent is a plus.

  • Ideal candidates for a Principal role with have 12+ years of CGMP experience.

  • Previous experience conducting sterile facility inspections is strongly preferred, but consideration will be given to others with significant manufacturing facility inspection experience.


Knowledge and Experience:

  • Previous Compliance experience as a Consumer Safety Officer with a regulatory agency (such as FDA, EMA, MHRA) is required.

  • Strong CGMP knowledge is required.


Skills:

  • High-level consulting skills

  • Critical thinking and problem-solving skills

  • Project leadership and management knowledge

  • Excellent interpersonal and intercultural communication skills, both written and verbal

  • Meticulous attention to detail and the ability to spot issues.

  • Client-focused approach to work

  • Results orientation

  • Teamwork and collaboration skills

  • Proficiency in local language and extensive working knowledge of the English language

  • Proactive

  • Networking

  • Business acumen and analysis

  • Self-confidence and control


Domestic and International Travel is required with an expectation of 50% travel averaged over a year.


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