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Manager Fda Consulting Jobs (NOW HIRING)

CYNET SYSTEMS

Staff Quality Engineer

Marlborough, MA · On-site

$55 - $59/hr

... risk management. * Strong knowledge of FDA and ISO quality and regulatory requirements ... S. states and Canada, we support thousands of consultants through our expansive, high-performing ...

E Logic

Project Manager

Silver Spring, MD · On-site

$85K/yr

E-logic is seeking a veteran Project Manager (PM) to lead a mission-critical federal contract ... FDA). Hiring is contingent upon the selection of the consultant. Selected candidates will be ...

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Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a Manager in FDA Consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a Manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

How does a Manager in FDA Consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
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Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in the United States as of May 2026, with employment types broken down into 79% Full Time, 14% Part Time, and 7% Contract. Highlights an 93% In-person, and 7% Hybrid job distribution.

PHARMACEUTICAL SR. CQV Manager/Lead

MMR Consulting

Seattle, WA • On-site

Other

Posted 22 days ago

Job description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role

(Commissioning, Qualification & Validation Pharmaceutical Manufacturing)


The work will require 90% travel to work in Denver/Boulder, Raleigh, midwest, Philadelphia, Portland, or other locations.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMRConsulting hasofficesinCanada,USA,andAustralia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning& qualification, start-up and project management of various processes, systems, and facilities.The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.

This role is forSr. CQV Manager/Leadwill require to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.

The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.


Key Responsibilities

  • Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.
  • Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
  • Coordinate commissioning and qualification activities for:
    • Process equipment
    • Clean utilities
    • HVAC systems
    • Automation and control systems
    • Manufacturing and packaging lines
  • Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
  • Oversee execution of:
    • FAT/SAT protocols
    • IQ/OQ/PQ protocols
    • Validation documentation
    • Deviations and CAPAs
    • Change controls
  • Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.
  • Manage third-party CQV consultants, contractors, and vendors.
  • Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.
  • Support startup, operational readiness, and technology transfer activities.
  • Present project status updates and KPI reporting to senior leadership and stakeholders.

Required Experience

  • Minimum 812 years of experience in pharmaceutical, biotech, or life sciences industries.
  • Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.
  • Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects.
  • Strong experience with commissioning and qualification of:
    • Cleanrooms
    • Process equipment
    • Utilities
    • Automation systems
    • Manufacturing processes
  • Experience authoring and reviewing validation lifecycle documentation.
  • Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.
  • Experience supporting FDA audits and regulatory inspections.
  • Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.

Required Qualifications

  • Bachelors degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
  • Strong understanding of:
    • cGMP regulations
    • FDA validation requirements
    • ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
    • GAMP 5 principles
  • Proficiency with project management methodologies, scheduling tools, and reporting systems.
  • Excellent communication, leadership, and stakeholder management skills.
  • Ability to work effectively in fast-paced, highly regulated project environments.

Preferred Qualifications

  • Digital Validation software experience (i.e. Kneat or equivalent)
  • PMP certification preferred.
  • Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.
  • Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.
  • Previous consulting or EPCM experience is a plus.
  • Lean Six Sigma certification preferred.

Compensation:120,000$-150,000$basedonexperience.


Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.