New · posted Nov 6
ICON · Pharmaceuticals
Quality Assurance Auditor II
- Cambridge, MA
- Hybrid
- Full-time
- Senior & Principal
The role
We are looking for a Quality Assurance Auditor to join our Global vibrant and passionate Laboratory Auditing Team. You will partner with internal stakeholders, performing a variety of audit activities with our Laboratory environment.
QA Auditor II- Cambridge MA- hybrid
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What you need
Experience and qualifications required
· Experience as a Quality Assurance/ Compliance Auditor
· Experience within a Laboratory or Clinical environment in an advantage
· Experience with, with ICH-GCP and with relevant GxP regulations and guidelines.
· BSc Degree is required
· Strong communication and relationship management skills
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
What you'll do
Responsibilities will include ( not limited to)
• Performing tasks relevant to our Lab environment such as conducting internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management.
• Working within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.
• Providing advice to operations on quality related issues
• Escalating quality and compliance issues to Quality & Compliance Line Management and relevant ICON functions as appropriate
• Performing Quality & Compliance review of SOPs when designated this responsibility, and contribute to the development & maintenance of departmental and general procedures
• If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.
Pay and benefits
$68,616 – $85,770 a year
Employer provided$68,616.00-$85,770.00
Are you a current ICON Employee? Please click here to apply
Rewards & Benefits
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAWorking conditions
Location: Cambridge MA- working within our Laboratory environment
Due the business function alignment of this role, there is a requirement for the individual to be onsite at the Laboratory 3 out of 5 days.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Equal opportunity, accessibility and legal noticesICON's statements, word for word
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 41% below the US median for Quality Auditing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $68,616 | — | $85,770 |
| All US (middle half) | $112,875 | $131,000 | $152,625 |
This role: ICON's own published range. Comparisons: the base pay employers published on open Quality Auditing roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Auditing
The general path across 24 open Quality Auditing roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Career resources on Quality Auditing
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Documentation and SOPs3
- Collaboration and leadership3
- Lab testing and methods2
- Investigations and CAPA1
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Auditing work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
Company hiring pulse
ICON on Regulatory Jobs
- 139
- Open roles
- 139
- Distinct roles
- 33
- Locations
By discipline
- Clinical134 92%
- Quality8 5%
- Regulatory4 3%
By level
- Senior & Principal62 42%
- Associate & Specialist59 40%
- Manager20 14%
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Quality Assurance Auditor II at ICON
Open until filled. $69K–$86K a year, employer provided.