Senior Director, Quality Assurance — GxP Systems

Job overview

The Senior Director, Quality Assurance — GxP Systems role is hybrid, with three days per week in Needham, MA and two days remote. The listed annual salary range is $258,000–$279,998, with a 25% bonus stated in the posting. Candel Therapeutics develops cancer immunotherapies intended to advance treatment options for patients and families. Reporting to the SVP of Quality, this leader owns GxP systems effectiveness across departments. The role builds compliant systems and processes, oversees vendors and audits, enables scientific teams, and supports the company’s work toward bringing oncology therapies to market.

What you'll do

• Manage the lifecycle of GxP systems across QA, Clinical Operations, CMC, and Research
• ensure compliance with 21 CFR Part 11 and industry standards
• lead vendor qualification, risk assessment, oversight, and auditing
• support data integrity for BLA-enabling work
• deliver systems training and continuous improvement
• oversee document review, bundling, and archiving for batch records, stability studies, and QA releases.

What we're looking for

Skills & competencies

senior director

quality assurance

gxp systems

biopharma

21 cfr part 11

vendor oversight

auditing

eqms

edms

needham ma

hybrid

$258k–$280k

25% bonus

candel therapeutics

Work arrangement

• Weekend coverage required

Benefits & perks

• The posting describes a 25% bonus and a supportive, mission-driven environment
• specific benefit plans are not listed.

Why this role

The posting describes a 25% bonus and a mission-driven, collaborative environment focused on cancer immunotherapies.

About the employer

Candel Therapeutics is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.