New · posted Oct 14
Beam Therapeutics · Biotechnology
Senior Manager / Associate Director, Clinical Quality Assurance
- Cambridge, MA
- On-site
- Full-time
- Director
Open until filled
The role
The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership for the qualification and ongoing quality oversight of CROs and other clinical service providers while providing clinical quality support for assigned studies. This role will partner cross-functionally to implement risk-based vendor oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams. This position will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance.
What you need
- University degree in a scientific discipline/life sciences.
- Experience in a clinical stage biotech company preferred.
- 7+ years of relevant experience in clinical/GCP quality. Level will be commensurate with experience.
- 3+ years of experience conducting or managing GCP vendor and investigator site audits.
- Professional audit certification (e.g., ASQ CQA, RQAP-GCP) preferred.
- Direct experience qualifying and overseeing CROs and other service providers.
- Strong knowledge of GCP and applicable FDA, EMA, MHRA and ICH requirements.
- Demonstration ability to successfully partner cross-functionally.
- Excellent interpersonal effectiveness, including exceptional communication skills.
- Advanced computer skills, including experience working in Veeva.
- Consistent excellent judgement and pragmatic, risk-based decision making skills.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$155,000—$225,000 USD
What you'll do
- Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP service providers supporting clinical development.
- Maintain a risk-based vendor qualification and oversight framework, including qualification assessments, audits, periodic re-assessments and documentation of vendor quality status.
- Partner with study team members to ensure appropriate quality oversight of associated vendors.
- Determine overall audit strategy / schedule for external GCP/GCLP/GVP vendors, including which audits to conduct internally vs outsource.
- Support QA leadership for significant vendor quality issues, including investigations, RCA, CAPA development/assessment, and effectiveness.
- Support the development of and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits.
- Support execution of enterprise-wide GCP inspection readiness strategies and plans.
- Partner cross-functionally to promote effective sponsor oversight of outsourced activities consistent with ICH E6 R3 expectations.
- Serve as the Clinical QA Support for assigned studies and programs.
- Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents as requested.
- Contribute to the continued evolution of the Quality Management System, including oversight and trending of key quality metrics (internal and external).
- Support clinical and QA SOP development efforts.
- Ensure adherence to GxP requirements and SOPs.
- Embody Beam’s cultural values and align daily actions with departmental goals and company culture.
Pay
$155,000 – $225,000 a year
Employer providedWhere you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Beam
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Clinical Quality & Safety roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $225,000 |
| Massachusetts (middle half) | $200,375 | $227,500 | $240,500 |
| All US (middle half) | $201,000 | $230,000 | $265,000 |
This role: Beam Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Quality & Safety roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Quality & Safety
The general path across 24 open Clinical Quality & Safety roles on Regulatory Jobs, with the titles they carry most. Not Beam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Collaboration and leadership9
- Investigations and CAPA5
- Documentation and SOPs4
- Validation and qualification3
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
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.
Company hiring pulse
Beam on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 2
- Locations
By discipline
- Quality8 80%
- Regulatory1 10%
- Compliance & Safety1 10%
By level
- Director4 40%
- Associate & Specialist4 40%
- Manager1 10%
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Senior Manager / Associate Director, Clinical Quality Assurance at Beam
Open until filled. $155K–$225K a year, employer provided.