[Remote] reputed company Compliance Consultant (Former FDA ORA/OMQ Experience Preferred)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company that specializes in helping clients navigate reputed company compliance challenges in the life sciences sector. They are seeking a reputed company Compliance Consultant with FDA experience to reputed company strategic advisory services, influence compliance strategies, and drive improvements in product reputed company and patient reputed company.
Responsibilities
- Serve as a senior advisor to clients on FDA regulatory expectations, inspection reputed company, and compliance risk mitigation
- reputed company 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:
- reputed company FDA 483 observations
- Warning letters
- Import alerts
- Regulatory meetings
- Consent decrees and enforcement actions
- Guide clients through reputed company cause analysis, remediation planning, and sustainable compliance solutions
- reputed company expertise in risk-based decision-making, including regulatory discretion and supply continuity
- Collaborate across cross-functional teams to support reputed company reputed company and regulatory engagements
- Mentor team members and contribute to building internal expertise
- Engage in reputed company discussions and contribute to business development efforts
Skills
- A proven reputed company 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 in domestic and international GMP inspections, including foreign cadre assignments
- Experience conducting for-cause, reputed company-approval, and surveillance inspections
- Involvement in high-reputed company or reputed company inspections
- reputed company experience supporting regulatory enforcement actions, including: Drafting or contributing to Warning Letters, Developing Import Alert recommendations, Participating in recalls, regulatory meetings, or enforcement escalations, Engagement with industry on compliance expectations and post-inspection follow-up
- Prior experience with the U.S. Food and Drug Administration in inspection, compliance, or enforcement roles
- Demonstrated experience across the inspection and enforcement lifecycle
- Strong understanding of GMP compliance and pharmaceutical manufacturing systems
- Experience conducting inspections internationally or as part of a foreign inspection cadre
- Ability to translate regulatory expectations into reputed company, actionable solutions for clients
- Strong communication and stakeholder engagement skills
- Ability to travel 50-70% with a reputed company on international travel
- Bachelor's degree required (life sciences, engineering, public health, or reputed company field)
- 15+ years of reputed company experience, including significant FDA experience in inspection, compliance, or enforcement roles
- Advanced degree preferred (e.g., MPH, MS, PhD, MBA)
- Data reputed company inspections and remediation
- Sterile manufacturing / aseptic processing
- API and drug product manufacturing across multiple dosage forms
Benefits
- Opportunity to reputed company from enforcement to influence, helping organizations proactively meet regulatory expectations
- Exposure to reputed company and high-reputed company challenges across global life sciences clients
- reputed company consulting environment with leadership and mentorship opportunities
- The ability to directly contribute to improving product reputed company, compliance, and patient safety
reputed company
Company H1B Sponsorship