Director, Clinical Quality Assurance
About the role
A Clinical Quality Assurance (QA) Specialist – Oncology is needed to support quality and compliance activities across oncology clinical development programs. The role involves maintaining and improving the Clinical Quality Management System (QMS) and ensuring clinical trials meet Good Clinical Practice (GCP), regulatory, and internal quality expectations. Collaboration with Clinical Operations and cross-functional teams is essential.
Responsibilities
- Support QMS maintenance, SOP updates, and regulatory compliance
- Assist with internal and external audits, documentation, and CAPA tracking
- Partner with Clinical Operations on quality oversight and issue resolution
- Support clinical trial documentation, processes, and TMF review
- Contribute to GCP/QA training and maintain systems like eQMS, CTMS, and eTMF
Requirements
- Bachelor’s degree in life sciences preferred
- 5+ years in clinical development with ICH guideline familiarity
- Experience with QA, QMS, audits, or SOP development is a plus
- Strong organizational, communication, and problem-solving skills
- Proficiency in Microsoft Office; familiarity with CTMS, eTMF, or eQMS preferred
Qualifications
- Experience with QA, QMS, audits, or SOP development is a plus
- Strong organizational, communication, and problem-solving skills
- Proficiency in Microsoft Office; familiarity with CTMS, eTMF, or eQMS preferred
Skills
- Experience with QA, QMS, audits, or SOP development is a plus
- Strong organizational, communication, and problem-solving skills
- Proficiency in Microsoft Office; familiarity with CTMS, eTMF, or eQMS preferred
Benefits
Everforth Apex offers a comprehensive benefits package including medical, dental, vision, life, disability, and other insurance plans, an ESPP (employee stock purchase program), a 401K program with a company match, and a HSA (Health Savings Account on the HDHP plan). Additionally, there is a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program, and other discounts. Professional development includes an on-demand training program, access to certification prep and a library of technical and leadership courses/books/seminars, and certification discounts and other perks to associations like CompTIA and IIBA. An Everforth Apex team member can provide a full list of benefits, programs, support teams, and resources within the 'Welcome Packet' upon request.
Pay
Details on pay are not specified in the job posting.
Schedule
The role is a hybrid role with a minimum of 2 days onsite in Waltham, MA. Flexible hours are provided to support global collaboration.