Principal Compliance Consultant - Data Integrity exp is a plus
WFA Digital Insight
The shift to remote work has accelerated demand for skilled compliance professionals, with a 25% increase in job postings over the past year. As a Principal Compliance Consultant at Parexel, you'll apply your expertise in FDA regulations and data integrity to drive solutions and meaningful impact for clients. With the life sciences industry evolving rapidly, companies are seeking professionals who can navigate complex regulatory landscapes. Parexel stands out for its commitment to improving global health, and this role offers a unique opportunity to transition from enforcement to strategic advisory work. Before applying, candidates should be prepared to showcase their experience in FDA inspections, compliance risk mitigation, and regulatory strategy.
Job Description
About the Role
As a Principal Compliance Consultant at Parexel, you will play a critical role in helping clients navigate complex regulatory challenges and achieve compliance with FDA regulations. Your expertise in data integrity, compliance, and regulatory affairs will be essential in driving solutions and meaningful impact for clients. You will work closely with cross-functional teams to support complex quality and regulatory engagements, mentoring team members and contributing to building internal expertise.The Principal Compliance Consultant role is designed for senior professionals who have built deep expertise within the FDA and are now interested in applying that experience in a more proactive, solution-oriented environment. You will have the opportunity to work directly with clients to identify risks early, solve complex regulatory challenges, and help organizations achieve and sustain compliance.
Parexel's Strategic Compliance team is growing, and this role is a key part of that growth. You will be part of a team of experienced professionals who are passionate about improving global health and committed to making a difference.
What You Will Do
- Serve as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigation
- Lead inspection readiness and mock inspection programs, helping clients prepare with confidence
- Apply firsthand FDA knowledge to anticipate inspection findings and proactively address gaps
- Advise on and support response strategies for Form FDA 483 observations, Warning letters, Import alerts, Regulatory meetings, Consent decrees, and enforcement actions
- Guide clients through root cause analysis, remediation planning, and sustainable compliance solutions
- Provide expertise in risk-based decision-making, including regulatory discretion and supply continuity
- Collaborate across cross-functional teams to support complex quality and regulatory engagements
- Mentor team members and contribute to building internal expertise
- Engage in client discussions and contribute to business development efforts
- Develop and maintain relationships with key clients and stakeholders
- Stay up-to-date with changing regulatory requirements and industry trends
What We Are Looking For
- A proven track record of experience working at the FDA in the Office of Regulatory Affairs (ORA), Office of Inspections and Investigations (OII), and/or Office of Compliance (CDER)
- Leadership experience in domestic and international GMP inspections, including foreign cadre assignments
- Experience conducting for-cause, pre-approval, and surveillance inspections
- Involvement in high-priority or complex inspections
- Direct experience supporting regulatory enforcement actions, including drafting or contributing to Warning Letters, developing Import Alert recommendations, participating in recalls, regulatory meetings, or enforcement escalations
- Strong knowledge of FDA regulations, guidance, and industry standards
- Experience with data integrity inspections and remediation
- Strong analytical, problem-solving, and communication skills
- Ability to work in a fast-paced environment and prioritize multiple projects
Nice to Have
- Experience with sterile manufacturing/aseptic processing and API
- Knowledge of risk-based decision-making and regulatory discretion
- Experience with supply continuity and regulatory strategy
- Certification in regulatory affairs or quality assurance
- Experience with client-facing advisory work
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a global leader in the life sciences industry
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Flexible working arrangements, including remote work options
- Access to cutting-edge technology and resources
- Comprehensive health and wellness programs
- Generous paid time off and holiday schedule
How to Stand Out
- Highlight your experience working with FDA regulations and data integrity in your application and during interviews.
- Emphasize your ability to communicate complex regulatory information to clients and stakeholders.
- Be prepared to provide specific examples of your experience with inspection readiness, mock inspections, and compliance risk mitigation.
- Showcase your knowledge of risk-based decision-making and regulatory discretion.
- Tailor your resume and cover letter to the specific requirements of the role, and be prepared to discuss your experience and skills in detail during interviews.
- Research Parexel's company culture and values, and be prepared to discuss how your own values and goals align with theirs.
- Prepare to discuss your experience with client-facing advisory work and your ability to build strong relationships with clients and stakeholders.
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