Senior Consultant, Compliance (GMP, QMS)
Location: United States (Remote)
Work Type: Full-time
Company: ProPharma
Industry: Biopharmaceutical / Quality & Compliance Consulting
Job Description:
ProPharma is seeking a Senior Consultant, Compliance (GMP, QMS) to lead and manage regulatory compliance and quality assurance (QA) projects. This role serves as a subject matter expert (SME) in GMP systems, offering independent consulting services for biotech, medical device, and pharmaceutical clients. You'll drive client-facing engagements, provide risk-based solutions, and contribute to the growth of compliance services.
Key Responsibilities:
Compliance Consulting & Leadership:
Serve as SME in assigned QA, GMP, and regulatory compliance areas.
Manage risk-based and phase-appropriate GMP projects independently.
Advise clients on QA/QMS strategies, inspections, remediation, and system implementation.
Stay current on regulatory and technological developments (FDA, EMA, MHRA, ICH).
Client Engagement & Business Development:
Participate in client discovery calls and scoping as an SME.
Define project scope, effort, and deliverables in collaboration with internal teams.
Support marketing initiatives by creating content (blogs, social media) and delivering presentations on QA/GMP topics.
Build strong client relationships and ensure high satisfaction.
Internal Contribution & Improvement:
Promote continuous improvement in customer delivery and consulting methodology.
Mentor junior consultants and provide internal training in GMP/QMS principles.
Required Skills and Abilities:
Strong knowledge of U.S. FDA, ICH, EMA, and MHRA regulatory expectations.
Deep expertise in GMP systems with hands-on, independent consulting experience.
Excellent verbal and written communication skills in English.
Capable of managing complex client engagements and earning client trust.
Willingness to travel for client meetings and inspections as needed.
Strong interpersonal skills and a collaborative mindset.
Educational Requirements:
Bachelor’s degree in a scientific discipline required.
Advanced degree (MSc/PhD) preferred.
Experience Requirements:
Minimum 10 years of experience in QA and GxP regulatory compliance.
Minimum 3 years in a leadership or SME role within compliance, quality, or regulatory functions.
Experience managing a technology business unit is an advantage.
Salary Estimate:
Estimated range: $130,000 – $170,000 USD per year (based on U.S. GMP/QMS consulting roles at senior level)
Diversity & Inclusion Commitment:
ProPharma is an Equal Opportunity Employer committed to creating an inclusive and supportive workplace. We value diversity and empower employees to bring their full, authentic selves to work.
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