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Senior Consultant, Compliance (Gmp, Qms)

10+ years
$130,000 – $170,000 USD per year
10 July 31, 2025
Job Description
Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.