New · posted Oct 20
Novartis · Pharmaceuticals
Director, Study Quality and Compliance - Nonclinical Safety/Toxicology
- Cambridge, MA
- Hybrid
- Full-time
- Director
Closes Oct 26, 2026 · 7 days left
The role
Location: Cambridge MA
Internal: Director
LI#-Hybrid
This role oversees the Study Quality and Compliance team within the Toxicology line function of PCS. This team is responsible for: handling samples and data associated with both internally and externally conducted toxicology studies; maintaining departmental SOPs, and oversight of training records for departmental personnel; and interfacing with the archives function to ensure proper storage of toxicology-related materials and records. A major part of this role will be to identify and implement a software system that enables effective tracking and analytics of study-related information that this group is responsible for overseeing.
What you need
- Advanced degree in biological-related sciences with at least 10 years of relevant pharmaceutical experience, BS degree in biological-related science with at least 15 years of experience, or 25+ years of relevant industry experience in oversight and compliance of toxicology studies.
- Previous experience working with GLP guidelines and pharmaceutical toxicology studies, and associated quality, compliance, and animal welfare attributes
- Previous experience with software tools for data and/or program management is highly desired
- Previous experience with SEND, or at a minimum good general familiarity with its requirements is desired
- Good communication skills, and excellent logistical/planning skills
- Fluent in English (spoken and written)
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
Skills Desirednice to have
Animal Models, Bioinformatics, Collaboration, Communication, Data Analysis, Decision Making, Ethics, Laboratory Research, Leadership, Management Techniques, Mentorship, Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology, Training and Development, Waterfall Model
What you'll do
- Lead and provide strategic oversight to the PCS Study Quality and Compliance team including responsibility for establishing long-term strategy and yearly goals which support it
- Modernize the group functionality leading the implementation of tracking, management, and data analytics software (eg, Smartsheet) across the toxicology line function to enhance quality and compliance oversight of toxicology studies
- Oversight of toxicology study data management from external and internal studies; this includes data suitability and availability for our internal toxicology study data warehouse
- Oversight and responsibility for ensuring SEND datasets are of high-quality and are ready in a timely manner for regulatory submissions, which includes SEND datasets from external CRO and de novo generation for internal non-GLP studies
- Oversight of SOPs and training records for PCS personnel to ensure compliance with GLP expectations, and serve as the management interface with the Archive Records Management team
- Oversight of support for biomarker and pathology with respect to shipment of study samples and data transfer of digital slides
- Support diligence acquisition and licensing deals through oversight and management of study-related data (including SEND) that need to be transferred
Pay and benefits
$185,500 – $344,500 a year
Employer provided$185,500.00 - $344,500.00
The salary for this position is expected to range between: $185,500 and $344,500 per year.
Health, life and disability benefits
401(k) with company contribution and match
Vacation, personal days and holidays
Performance-based cash incentive
Eligibility for annual equity awards
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAEqual opportunity, accessibility and legal noticesNovartis's statements, word for word
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% above the US median for Compliance roles at this level.
This roleEmployer provided
Director roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $185,500 | — | $344,500 |
| All US (middle half) | $207,875 | $220,000 | $249,375 |
This role: Novartis's own published range. Comparisons: the base pay employers published on open Compliance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Compliance
The general path across 40 open Compliance roles on Regulatory Jobs, with the titles they carry most. Not Novartis's own promotion track.
Career resources on Compliance
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Collaboration and leadership5
- Data and digital systems4
- Lab testing and methods3
- Documentation and SOPs2
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Novartis on Regulatory Jobs
- 12
- Open roles
- 11
- Distinct roles
- 6
- Locations
By discipline
- Quality9 75%
- Compliance & Safety3 25%
By level
- Senior & Principal5 42%
- Director3 25%
- Associate & Specialist3 25%
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Director, Study Quality and Compliance - Nonclinical Safety/Toxicology at Novartis
Applications close October 26. $186K–$345K a year, employer provided.