[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 reputed company 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 reputed company 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 reputed company 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. reputed company 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, reputed company 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 reputed company is a biopharmaceutical services company that focuses on the development and commercialization of new medical therapies worldwide. It is a sub-organization of EQT. It was founded in 1983, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees.

Its website is http//www. reputed company. com.

Company H1B Sponsorship reputed company has a reputed company record of offering H1B sponsorships, with 22 in 2026, 32 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply To This Job