Quality Compliance Specialist
- Location
- Cambridge, MA · On-site
- Job type
- Full-time
- Level
- Senior
- Experience
- 3+ years
- Education
- Bachelor's degree
- Listed
- Today
Skills & highlights for this role
- cGMP regulations (US, EU)
- Quality assurance or compliance in pharmaceutical/biotech
- Audit knowledge and skills
- Microsoft Office
- TrackWise
- Learning/Document Management Systems
- Written and verbal communication in English
Also useful
- Oncology quality experience
- Contract manufacturing organization oversight
- Presentation development and delivery
About the role
- Performs or supports the execution of the following activities:
- Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US.
- Tracking of required corrective actions resulting from self-assessments or inspection readiness activities.
- Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of Oncology and (ESSM) - US Region departments.
- Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.
- Support the Oncology and ESSM US Region Document Management and Training process owner in th the development and implementation of training curriculums, and develop training material for local procedures.
- Support the collection of pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).
- Support the Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals and generation of the Approved Supplier List.
- Receive overall project direction from management but completes most work independently.
- Independently write new Oncology and ESSM Quality procedures and revise existing procedures.
- Complete required training and keep training files current.
- Additional tasks and duties as assigned.
Qualifications & Requirements
- Bachelor of Science (BS) degree and 3+ years' experience in QA or related compliance area in the pharmaceutical/biotech industry.
- Knowledge of cGMP regulations for US, EU and other markets including audit knowledge and skills.
- Effective time management, detail-oriented work style, and superior at teamwork and collaboration.
- Excellent organizational, presentation development and delivery skills.
- Proficient computer, verbal and written communication skills.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
- Must be able to read, write and converse in English.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint, Learning/Document Management Systems and Trackwise.
- Wrist and hand motion (e.g. typing, writing).
Additional Information
All your information will be kept confidential according to EEO guidelines.
About the Company
- Support projects and initiatives within the Oncology and External Supply Small Molecule (ESSM) Quality - US Region organization to ensure Quality Compliance with GxP regulations and quality/technical agreements.
- Support the successful execution of regulatory body visits, both internally and at Contract Manufacturing Organizations (CMOs), by supporting the pre-inspection activities, overseeing the fulfilment of requests during the inspection, and coordinating post-inspections activities as assigned.
From Arindhaal's careers page, first listed on Rolev.ai on November 12, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
Rolev.ai is a job search and application tool for US job seekers. For this Quality Compliance Specialist role at Arindhaal, it shows how your resume fits, tailors your resume to the posting, and prepares the application for you to review.
See how you fit
Openings from employer career sites are ranked against your whole resume—and searchable inside Claude, ChatGPT, and Cursor via Rolev.ai MCP.
Tailor without inventing
Every change to your resume is checked against your original. New experience goes in only with your yes—zero fabricated claims.
Draft the full kit
Tailored and Full Match resumes, role-specific cover letters, and answers to employer screening questions are prepared in seconds.
1-Click Extension Autofill
The Chrome extension fills the employer's Greenhouse, Workday, Lever, or Ashby form in 1 click. You review it and press Submit.
Common questions
Where is the Quality Compliance Specialist job at Arindhaal located?
This Quality Compliance Specialist position at Arindhaal is located in Cambridge, MA (On-site). Always check Arindhaal's application page for specific state eligibility or relocation policies.
What qualifications are required for Quality Compliance Specialist at Arindhaal?
For the Quality Compliance Specialist role, Arindhaal highlights 3+ years of relevant experience; a bachelor's degree; experience with cGMP regulations (US, EU), Quality assurance or compliance in pharmaceutical/biotech, Audit knowledge and skills, Microsoft Office, TrackWise, Learning/Document Management Systems. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Quality Compliance Specialist position at Arindhaal?
This listing links directly to Arindhaal's SmartRecruiters application page. You can apply directly on Arindhaal's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the SmartRecruiters application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.