Pharmaceutical Consultant Jobs
Pharmaceutical Consultant jobs are open across biotech, medical devices, life sciences, and regulatory affairs, with specializations in clinical strategy, market access, and drug development, from associate to principal and director level. Find a role that fits below and apply directly.
Find JobsOverview
Showing 5 of 16+ Pharmaceutical Consultant jobs
Position Summary
The Technical Consultant – Quality Affairs SME is a pharmaceutical quality assurance expert for HHS/ASPR's DPA-ERA Office. The consultant brings hands-on pharmaceutical manufacturing quality experience to ASPR's use of delegated Defense Production Act Title III authorities to build domestic capacity for medical countermeasures (MCMs) and other essential health resources.
The consultant assesses performers' cGMP compliance, quality systems and manufacturing readiness on assigned Title III projects, including active pharmaceutical ingredient (API) and key starting material (KSM) production and sterilization capacity. Core work includes evaluating proposals, validating performer deliverables and advising Government decision-makers on quality risk.
Duties and Responsibilities
Scientific, Technical and Regulatory Advisory
- Provide pharmaceutical quality expertise across drug substance and drug product manufacturing, including APIs and KSMs, small molecules, biologics, vaccines and sterile products.
- Advise on quality affairs pathways for planned and known ASPR procurements that require FDA review, focusing on cGMP compliance and the quality elements of performers' CMC readiness.
- Advise on innovative manufacturing and quality approaches, such as continuous manufacturing and advanced process controls, that support the development, manufacturing, licensure and distribution of MCMs.
- Advise on critical programmatic and project-level quality challenges, including quality system maturity, process validation, technology transfer, supplier qualification and data integrity.
Project Technical Leadership
- Serve as lead or backup technical consultant on assigned DPA Title III projects and attend recurring performer and project meetings.
- Review and validate performer deliverables, such as monthly reports, statements of work, project plans, validation and qualification packages, and milestone evidence.
- Conduct site visits to performer facilities to assess manufacturing progress, quality systems and readiness.
- Monitor performer schedules and notify DPA-ERA leadership promptly of bottlenecks, risks or slippage against milestones.
- Provide scientific and technical support on industry project analyses, with recommendations for development, optimization or maintenance of mission-specific or mission-critical efforts.
Evaluation, Research and Assessment
- Perform quality and manufacturing technical evaluations of DPA Title III Broad Agency Announcement white papers and full proposals, and of submissions received through partner consortia and interagency efforts.
- Support development and evaluation of Requests for Information (RFIs), with a focus on manufacturing quality and cGMP readiness.
- Conduct market and open-source research, industrial base assessments, and quality risk and gap assessments on priority pharmaceutical supply chains, such as essential medicines, antimicrobials, IV fluids and antibody manufacturing.
- Provide quality and manufacturing input to purchases, purchase commitments, grants, subsidies, loans and loan guarantees under ASPR's execution of HHS's delegated Title III authorities.
Stakeholder Engagement and Communication
- Facilitate engagement between HHS/ASPR and national organizations focused on manufacturing the materials and supplies needed to produce health resources deemed essential for national defense.
- Produce clear, concise written reports and oral briefings that communicate objectives and approaches to non-technical audiences.
- Conduct other tasks as assigned within the scope of the task order.
Qualifications
Minimum Qualifications
- Bachelor's degree in chemistry, biochemistry, biology, pharmaceutical sciences, pharmacy or chemical engineering.
- At least 8 years of hands-on quality assurance, quality control or validation experience in FDA-regulated pharmaceutical or biopharmaceutical manufacturing (drug substance, drug product or both).
- Working knowledge of pharmaceutical cGMP (21 CFR Parts 210 and 211), ICH Q7 and Q10, and related FDA quality guidance.
- Direct experience with core quality systems: deviations, OOS investigations, CAPA, change control, internal and external audits, document control, and batch record review and product disposition.
- Demonstrated ability to write clear technical reports and brief non-technical audiences.
- Proficiency with Microsoft Office and Adobe Acrobat.
- Ability to pass an HHS background investigation.
Preferred Qualifications
- At least 8 years of pharmaceutical industry experience in mid- or senior-level technical operations, with quality as the primary discipline.
- Advanced or doctoral degree in chemistry, biology, biotechnology or pharmacy, with commensurate experience.
- Experience supporting successful FDA approval of a drug or biologic, including quality and cGMP readiness for pre-approval inspection.
- Extensive knowledge of FDA and ICH quality guidelines and requirements.
Additional Preferred Qualifications
- Experience with API/KSM manufacturing, technology transfer, process performance qualification (PPQ), or CMO/CDMO quality oversight, including quality agreements.
- Experience with sterile manufacturing, aseptic processing (EU GMP Annex 1) or terminal sterilization (gamma, electron beam, X-ray, ethylene oxide).
- Supplier quality and GMP audit experience, including API and excipient suppliers.
- Experience hosting or supporting FDA inspections, including pre-approval inspections.
- Prior support to HHS/ASPR, BARDA or another federal agency on medical countermeasure or industrial base programs.
- Professional certification, such as ASQ Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
Pay: From $120,000.00 per year
Benefits:
- 401(k) matching
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: Hybrid remote in Washington, DC 20201
Position Summary
The Technical Consultant – Quality Affairs SME is a pharmaceutical quality assurance expert for HHS/ASPR's DPA-ERA Office. The consultant brings hands-on pharmaceutical manufacturing quality experience to ASPR's use of delegated Defense Production Act Title III authorities to build domestic capacity for medical countermeasures (MCMs) and other essential health resources.
The consultant assesses performers' cGMP compliance, quality systems and manufacturing readiness on assigned Title III projects, including active pharmaceutical ingredient (API) and key starting material (KSM) production and sterilization capacity. Core work includes evaluating proposals, validating performer deliverables and advising Government decision-makers on quality risk.
Duties and Responsibilities
Scientific, Technical and Regulatory Advisory
- Provide pharmaceutical quality expertise across drug substance and drug product manufacturing, including APIs and KSMs, small molecules, biologics, vaccines and sterile products.
- Advise on quality affairs pathways for planned and known ASPR procurements that require FDA review, focusing on cGMP compliance and the quality elements of performers' CMC readiness.
- Advise on innovative manufacturing and quality approaches, such as continuous manufacturing and advanced process controls, that support the development, manufacturing, licensure and distribution of MCMs.
- Advise on critical programmatic and project-level quality challenges, including quality system maturity, process validation, technology transfer, supplier qualification and data integrity.
Project Technical Leadership
- Serve as lead or backup technical consultant on assigned DPA Title III projects and attend recurring performer and project meetings.
- Review and validate performer deliverables, such as monthly reports, statements of work, project plans, validation and qualification packages, and milestone evidence.
- Conduct site visits to performer facilities to assess manufacturing progress, quality systems and readiness.
- Monitor performer schedules and notify DPA-ERA leadership promptly of bottlenecks, risks or slippage against milestones.
- Provide scientific and technical support on industry project analyses, with recommendations for development, optimization or maintenance of mission-specific or mission-critical efforts.
Evaluation, Research and Assessment
- Perform quality and manufacturing technical evaluations of DPA Title III Broad Agency Announcement white papers and full proposals, and of submissions received through partner consortia and interagency efforts.
- Support development and evaluation of Requests for Information (RFIs), with a focus on manufacturing quality and cGMP readiness.
- Conduct market and open-source research, industrial base assessments, and quality risk and gap assessments on priority pharmaceutical supply chains, such as essential medicines, antimicrobials, IV fluids and antibody manufacturing.
- Provide quality and manufacturing input to purchases, purchase commitments, grants, subsidies, loans and loan guarantees under ASPR's execution of HHS's delegated Title III authorities.
Stakeholder Engagement and Communication
- Facilitate engagement between HHS/ASPR and national organizations focused on manufacturing the materials and supplies needed to produce health resources deemed essential for national defense.
- Produce clear, concise written reports and oral briefings that communicate objectives and approaches to non-technical audiences.
- Conduct other tasks as assigned within the scope of the task order.
Qualifications
Minimum Qualifications
- Bachelor's degree in chemistry, biochemistry, biology, pharmaceutical sciences, pharmacy or chemical engineering.
- At least 8 years of hands-on quality assurance, quality control or validation experience in FDA-regulated pharmaceutical or biopharmaceutical manufacturing (drug substance, drug product or both).
- Working knowledge of pharmaceutical cGMP (21 CFR Parts 210 and 211), ICH Q7 and Q10, and related FDA quality guidance.
- Direct experience with core quality systems: deviations, OOS investigations, CAPA, change control, internal and external audits, document control, and batch record review and product disposition.
- Demonstrated ability to write clear technical reports and brief non-technical audiences.
- Proficiency with Microsoft Office and Adobe Acrobat.
- Ability to pass an HHS background investigation.
Preferred Qualifications
- At least 8 years of pharmaceutical industry experience in mid- or senior-level technical operations, with quality as the primary discipline.
- Advanced or doctoral degree in chemistry, biology, biotechnology or pharmacy, with commensurate experience.
- Experience supporting successful FDA approval of a drug or biologic, including quality and cGMP readiness for pre-approval inspection.
- Extensive knowledge of FDA and ICH quality guidelines and requirements.
Additional Preferred Qualifications
- Experience with API/KSM manufacturing, technology transfer, process performance qualification (PPQ), or CMO/CDMO quality oversight, including quality agreements.
- Experience with sterile manufacturing, aseptic processing (EU GMP Annex 1) or terminal sterilization (gamma, electron beam, X-ray, ethylene oxide).
- Supplier quality and GMP audit experience, including API and excipient suppliers.
- Experience hosting or supporting FDA inspections, including pre-approval inspections.
- Prior support to HHS/ASPR, BARDA or another federal agency on medical countermeasure or industrial base programs.
- Professional certification, such as ASQ Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
Pay: From $120,000.00 per year
Benefits:
- 401(k) matching
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: Hybrid remote in Washington, DC 20201
Pharmaceutical Consultant Jobs by Experience Level
See All 16 Pharmaceutical Consultant Jobs
Find roles that match your experience and apply in just a few clicks.
Find JobsPharmaceutical Consultant Job Market
Who's Hiring
What Employers Look For
The qualifications that appear most often in pharmaceutical consultant jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, or a related field
- Experience with FDA regulatory submissions, GxP, or clinical trial processes
- Proficiency in data analysis tools such as Excel, SAS, or statistical software platforms
- Strong knowledge of pharmaceutical market access, pricing, or reimbursement strategies
- Ability to develop and present client-facing deliverables and strategic recommendations
- Project management experience managing cross-functional teams or multiple client accounts
Tips for Your Pharmaceutical Consultant Job Search
Tailor your resume to therapeutic area
Hiring managers in pharma consulting screen for domain depth first. If your background is oncology or rare disease, make that the headline of your resume rather than burying it in bullet points under each role.
Highlight regulatory and compliance fluency
Pharmaceutical consultant postings consistently weight FDA submission experience, GxP knowledge, and pharmacovigilance familiarity. Name the specific frameworks you've worked within so your resume passes both human and automated screening.
Apply early to roles that fit
Migrate Mate lists pharmaceutical consultant openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Prepare case-based interview answers
Pharmaceutical consulting interviews frequently include scenario questions about go-to-market strategy for a new drug or how to advise a client facing a clinical trial delay. Structure your answers around a real situation, your analysis, and the measurable outcome.
Target postings by engagement model
Some pharmaceutical consultant roles are project-based contracts with defined end dates while others are full-time embedded advisory positions. Reading job descriptions carefully for contract duration and client-facing expectations saves you from mismatched interviews.
Negotiate scope alongside compensation
In pharmaceutical consulting, the number and size of clients you're assigned directly affects career growth. When an offer comes, ask about expected client load, therapeutic area mix, and whether you'll have direct client contact or work through project managers.
Pharmaceutical Consultant Jobs: Frequently Asked Questions
Which companies are hiring the most pharmaceutical consultants?
ZS Associates, サイネオス・ヘルス, and Syneos Health Commercial Solutions are hiring the most pharmaceutical consultants right now, with openings concentrated in California, New York, and Massachusetts, based on current listings on Migrate Mate as of November 2026. Demand tends to cluster around large biopharma hubs and CRO networks, so it's worth searching by state if you're open to relocation.
How many pharmaceutical consultant jobs are remote?
About 100% of pharmaceutical consultant openings are fully remote or hybrid as of November 2026, reflecting the advisory and analysis-heavy nature of the work. Roles focused on regulatory strategy, medical affairs writing, and market access modeling tend to offer the most location flexibility, while positions requiring on-site client engagement or lab access are more likely to be in-person.
How do you become a pharmaceutical consultant?
Most pharmaceutical consultants start with a degree in life sciences, pharmacy, biochemistry, or a related field, then build direct industry experience in clinical operations, regulatory affairs, or commercial strategy before moving into consulting. Building expertise in a specific therapeutic area and gaining exposure to client-facing work, whether inside a pharma company or at a consulting firm, makes the transition more straightforward.
Can you get a pharmaceutical consultant job with little experience?
Entry-level pharmaceutical consultant roles do exist, particularly at larger consulting firms that hire junior analysts or associates with strong academic backgrounds in life sciences. Internships, co-ops, or research assistant positions inside a pharmaceutical company are the most direct route, since they give you the regulatory and scientific fluency that separates candidates with no prior consulting experience from those who can contribute immediately.
What does the pharmaceutical consultant interview process look like?
The process typically moves through an initial screening call with a recruiter or HR contact, followed by a technical interview focused on your domain knowledge in areas like regulatory submissions, clinical development, or market access. Final rounds often include a case study or presentation where you're asked to analyze a drug launch scenario or advise a hypothetical client, testing both your analytical approach and how clearly you communicate recommendations.
Where can I find and apply to pharmaceutical consultant jobs?
You can find and apply to pharmaceutical consultant jobs on Migrate Mate, which lists current openings from across the United States. Search the listings to find roles that match your therapeutic area, experience level, and work arrangement, then apply directly to each one that fits.
See All 16 Pharmaceutical Consultant Jobs
Find roles that match your experience and apply in just a few clicks.
Find Jobs