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Gxp Jobs in Reston, VA (NOW HIRING)

Quality Agents

Lab Technician - Biocentre

Gaithersburg, MD · On-site

$25 - $35/hr

Follow GxP and ISO 20387 standards and biobank SOPs; participate in internal audits, CAPAs, and continuous improvement activities; maintain current training records. * Monitor freezers and LN2 tanks ...

Inotivco

Bioanalysis Scientist I

Rockville, MD · On-site

Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents. * Experience interfacing with sponsors/clients on a wide ...

Inotiv

Bioanalysis Scientist I

Rockville, MD · On-site

Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents. * Experience interfacing with sponsors/clients on a wide ...

Inotiv

Bioanalysis Scientist I

Rockville, MD · On-site

Experience in complex method development and validation in a GxP or CLIA and CRO environment according to FDA and industry guidance documents. * Experience interfacing with sponsors/clients on a wide ...

AstraZeneca

Product Data Architect - Evinova

Gaithersburg, MD · On-site

$69 - $88.50/hr

Align data architecture with regulatory and enterprise standards (including GxP) * Support data governance practices like access, retention, and auditability * Identify risks and continuously improve ...

Marriott

FLEX OSR Rooms Operations Manager

Bethesda, MD · On-site

Champions GXP efforts to drive engagement and guest satisfaction scores. * Champions Marriott's Commitment to Clean processes and critical brand standards. * Provides Marriott Bonvoy Loyalty Subject ...

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How much do gxp jobs pay per hour?

As of Jul 17, 2026, the average hourly pay for gxp in Reston, VA is $15.25, according to ZipRecruiter salary data. Most workers in this role earn between $13.51 and $16.01 per hour, depending on experience, location, and employer.

What jobs pay 500,000 a year in the US?

High-paying jobs that can reach or exceed $500,000 annually include executive roles such as CEOs, CFOs, and other C-suite positions, as well as successful entrepreneurs, investment bankers, and certain specialized medical professionals like neurosurgeons. These roles typically require extensive experience, advanced skills, and often involve significant responsibilities or ownership stakes.

What are the key skills and qualifications needed to thrive as a GxP (Good Practice) Compliance Specialist, and why are they important?

To thrive as a GxP Compliance Specialist, you need a solid understanding of regulatory standards (such as GMP, GLP, and GCP), quality management systems, and often a degree in life sciences or a related field. Familiarity with audit management tools, electronic quality management systems (eQMS), and relevant certification (like RAC or ASQ CQA) is highly valued. Strong attention to detail, analytical mindset, and effective communication skills help ensure regulatory adherence and facilitate cross-functional collaboration. These competencies are crucial for maintaining product quality, patient safety, and compliance with industry regulations.

What are GxP jobs?

GxP jobs refer to roles that operate under 'Good Practice' guidelines in the life sciences and pharmaceutical industries, where 'GxP' stands for 'Good [x] Practice' (such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), or Good Clinical Practice (GCP)). These jobs are responsible for ensuring that products are developed, tested, manufactured, and distributed in compliance with regulatory standards to guarantee safety, quality, and integrity. GxP professionals may work in areas like quality assurance, laboratory management, clinical trials, and manufacturing. Their work is critical for meeting regulatory requirements set by agencies like the FDA or EMA. Adherence to GxP standards helps protect patient safety and product quality throughout the product lifecycle.

What is a GxP role?

A GxP role involves working within Good Practice guidelines (such as Good Manufacturing Practice, Good Clinical Practice, or Good Laboratory Practice) to ensure compliance with industry standards in regulated environments like pharmaceuticals, biotech, or medical devices. These roles often require knowledge of regulatory requirements, documentation, and quality assurance processes to maintain product safety and efficacy.

What is the 3 month rule for jobs?

The 3 month rule for jobs, including roles like Gxp, typically refers to a probationary period of three months during which an employee's performance and fit for the role are evaluated. This period often determines whether the employee will be confirmed in the position or if further review or termination is necessary, and it may involve specific performance metrics or training requirements.

What is the difference between Gxp vs Quality Assurance Specialist?

AspectGxpQuality Assurance Specialist
Required CredentialsGxp compliance training, industry-specific certificationsQuality assurance certifications, such as CQE or CQA
Work EnvironmentRegulated industries like pharmaceuticals, biotech, and medical devicesManufacturing, healthcare, or software industries
Employer & Industry UsageUsed in industries with strict regulatory standardsCommon in quality-focused roles across various sectors
Comparison Search IntentUnderstanding Gxp compliance rolesComparing quality assurance roles with Gxp responsibilities

Gxp professionals focus on ensuring compliance with Good Practice standards in regulated industries, while Quality Assurance Specialists oversee quality processes across various sectors. Both roles require quality-related certifications, but Gxp roles emphasize regulatory compliance specific to industries like pharmaceuticals and biotech. Understanding these differences helps job seekers identify the right career path based on industry and certification requirements.

What jobs pay 4000 a week without a degree?

For roles related to Gxp, high-paying positions such as sales managers, real estate brokers, or skilled trades like electricians and plumbers can earn around $4,000 weekly without a college degree, often requiring experience, certifications, or licenses. These jobs typically involve strong communication skills, technical knowledge, or specialized training and may have variable schedules or work environments.

How does a GxP professional typically collaborate with cross-functional teams to ensure regulatory compliance?

GxP professionals regularly work alongside teams such as quality assurance, manufacturing, research and development, and regulatory affairs to ensure all processes and documentation meet regulatory standards. This collaboration often involves facilitating audits, reviewing protocols, and providing training on compliance requirements. Effective communication and a proactive approach are key, as GxP professionals must ensure that all stakeholders understand and adhere to the relevant guidelines throughout the product lifecycle.
What job categories do people searching Gxp jobs in Reston, VA look for? The top searched job categories for Gxp jobs in Reston, VA are:
Gxp jobs near you
Infographic showing various Gxp job openings in Reston, VA as of July 2026, with employment types broken down into 91% Full Time, 2% Part Time, and 7% Contract. Highlights an 88% Physical, 3% Hybrid, and 9% Remote job distribution, with an average salary of $31,729 per year, or $15.3 per hour.

Business Capability Specialist

BioNTech SE

Gaithersburg, MD • Remote

$113K - $181K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 29 days ago

Job description

Cambridge, US; Gaithersburg, US; New Jersey, US   |   full time   |   Job ID: 11216 

About the Role

As a Business Capability Specialist, you will serve as the critical link between our business stakeholders and the Data, Digital & Informatics (DDI) organization, ensuring that technology solutions seamlessly enable key business capabilities and support BioNTech's mission. Working closely with Medical Affairs (MA) and Medical Safety & Pharmacovigilance (MSPv) teams, you will help identify opportunities for digital transformation, translate business needs into scalable technology solutions, and ensure compliance with regulatory standards. By combining your technical expertise with a strong understanding of business processes, you will play an integral role in driving innovation, improving operational efficiency, and delivering measurable value across the organization.

Your Contribution

  • Act as a trusted partner to Medical Affairs and MSPv teams to understand their needs and identify technology solutions aligned with BioNTech's strategic goals
  • Analyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency and effectiveness
  • Lead or support the planning, prioritization, implementation, and operational management of technology projects within GxP environments
  • Collaborate with cross-functional teams to develop process documentation (as-is/to-be), system requirements, functional specifications, and testing protocols
  • Support technology roadmap development by working closely with Business Partners and portfolio management teams
  • Partner with vendors to implement new technology solutions while ensuring seamless integration into existing systems
  • Troubleshoot operational issues and ensure systems meet regulatory and validation requirements (e.g., 21 CFR Part 11, EMA Annex 11)
  • Support GxP Computer System Validation activities by creating key documentation such as Validation Plans, User Requirements Specifications (URS), Testing Protocols (IQ/OQ/PQ/UAT), Traceability Matrices, and Validation Summary Reports
  • Collaborate with procurement, legal, finance, quality partners, and other stakeholders on contracts and operational processes for quality systems

A Good Match

  • Bachelor's degree in Computer Science, Mathematics, Information Systems, or Life Sciences-related fields
  • 5+ years of experience as a Business Analyst within the Life Sciences industry; experience supporting Medical Affairs or MSPv is highly preferred
  • Deep understanding of R&D business processes and data management within pharmaceutical settings
  • Strong knowledge of technologies and trends in the pharmaceutical industry; experience supporting digital platforms commonly used in Global Development organizations is a plus
  • Expertise in business process mapping efforts (as-is/to-be), gap analysis methodologies, project management principles, and leading international project teams
  • Familiarity with GxP guidelines (e.g., 21 CFR Part 11) and Computer System Validation processes
  • Exceptional analytical skills combined with a proactive mindset to solve complex problems collaboratively
  • Superb interpersonal skills with an ability to engage effectively across diverse teams

Expected Pay Range:  $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

  • Medical, Dental and Vision Insurance
  • Life, AD&D, Critical Illness Insurance
  • Pre-tax HSA & FSA, DCRA Spending Accounts
  • Employee Assistance & Concierge Program (EAP) available 24/7
  • Parental and Childbirth Leave & Family Planning Assistance
  • Sitterstream: Virtual Tutoring & Childcare Membership
  • Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
  • 401(K) Plan with Company Match
  • Tuition Reimbursement & Student Loan Assistance Programs
  • Wellbeing Incentive Platforms & Incentives
  • Professional Development Programs
  • Commuting Allowance and subsidized parking
  • Discounted Home, Auto & Pet Insurance

...and more! More details to be shared.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.

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