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Fda Jobs in Massachusetts (NOW HIRING)

Ipsen

$163K - $216K/yr

The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made ...

Cipla

QA Compliance Manager

Fall River, MA · On-site

$86K - $113K/yr

Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...

Cipla

QA Compliance Manager

Fall River, MA · On-site

$86K - $113K/yr

Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...

Jobtailor

Production Manager

Mansfield, MA · On-site

$150 - $190/hr

* Lead production of an FDA Class III medical device in production and ramp‑up for a strategic OEM * Ensure adherence to released processes and meet production demand * Lead continuous improvement ...

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Fda information

What does an FDA professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.

What are the most commonly searched types of Fda jobs in Massachusetts?

The most popular types of Fda jobs in Massachusetts are:

What are popular job titles related to Fda jobs in Massachusetts?

For Fda jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Fda jobs in Massachusetts look for?

The top searched job categories for Fda jobs in Massachusetts are:

What cities in Massachusetts are hiring for Fda jobs?

Cities in Massachusetts with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Massachusetts as of August 2026, with employment types broken down into 75% Full Time, 12% Part Time, and 13% Contract. Highlights an 100% In-person job distribution.

GMP Manufacturing & Quality Systems Gap Assessment Consultant - 2-Day Onsite in Pennsylvania

The FDA Group

Boston, MA

Full-time

Posted 8 days ago

Job description

Manufacturing & Quality Systems Gap Assessment Consultant

Location: Onsite – Pennsylvania
Work Arrangement: 2-day onsite assessment with additional offsite assessment and reporting activities
Duration: Approximately 40–45 total project hours; completion prior to the end of September
Schedule: 2 days onsite, with remaining project hours dedicated to assessment preparation, analysis, and reporting

Position Overview

A regulated manufacturing organization is seeking an experienced consultant to conduct a comprehensive gap assessment of its manufacturing and quality systems.

The consultant will evaluate current operations against applicable FDA regulatory requirements, current Good Manufacturing Practice (cGMP) regulations, and relevant industry standards using a systematic, risk-based approach.

The assessment will place particular emphasis on defect identification and extrinsic particle controls, as well as regulatory and GMP requirements associated with hormone manufacturing. The consultant will quantify identified gaps and provide practical recommendations for corrective and preventive actions (CAPAs).

Key Responsibilities

  • Conduct a systematic, risk-based gap assessment of manufacturing and quality systems against applicable FDA requirements, cGMP regulations, and industry standards.

  • Perform a 2-day onsite assessment of relevant manufacturing operations and quality systems.

  • Evaluate the organization's approach to defect identification and identify gaps affecting regulatory compliance.

  • Assess regulatory expectations related to extrinsic particles and, where appropriate, evaluate acceptable thresholds and associated controls.

  • Assess regulatory and GMP requirements for the setup, operation, and handling of hormone manufacturing activities.

  • Identify and document observations, deficiencies, and compliance risks identified during the assessment.

  • Provide quantifiable assessment results that enable the organization to understand and prioritize identified gaps.

  • Recommend appropriate CAPAs to address identified observations and deficiencies.

  • Provide practical, risk-based recommendations to strengthen manufacturing and quality systems and support ongoing compliance.

Required Qualifications

  • Strong knowledge of applicable FDA regulatory requirements and cGMP regulations for regulated manufacturing operations.

  • Demonstrated experience conducting manufacturing and quality systems gap assessments.

  • Ability to apply systematic, risk-based assessment methodologies.

  • Experience identifying compliance gaps and developing appropriate CAPA recommendations.

Preferred Qualifications

  • Former FDA experience.

  • Experience evaluating defect identification programs and controls related to extrinsic particles.

  • Experience with regulatory and GMP considerations associated with hormone manufacturing.

Work Arrangement

The engagement includes a 2-day onsite assessment in  Pennsylvania, followed by the analysis, documentation, and reporting activities necessary to complete the assessment. The total engagement is expected to require approximately 40–45 hours and be completed prior to the end of September.

Ideal Candidate

The ideal consultant is an experienced FDA compliance and cGMP professional, preferably with former FDA experience, who can independently assess manufacturing and quality systems, identify and quantify compliance gaps, and translate findings into practical, risk-based CAPA recommendations.