Principal CGMP Compliance Consultant
United States of America, Remote Additional Locations: Remote - United States of America Job ID R0000017692 Category Regulatory / Consulting Date Posted 02/23/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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