ACCELERON PHARMA INC Associate Director, Clinical Quality Assurance Salary in the United States

How much does a Associate Director, Clinical Quality Assurance make at companies like ACCELERON PHARMA INC in the United States? The average salary for Associate Director, Clinical Quality Assurance at companies like ACCELERON PHARMA INC in the United States is $134,886 as of August 27, 2023, but the range typically falls between $119,074 and $150,697. Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, helps you determine your exact pay target.  View the Cost of Living in Major Cities2


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What does a Associate Director, Clinical Quality Assurance do at companies like ACCELERON PHARMA INC?

What’s in it for you?

The Associate Director of Clinical Quality Assurance (QA) will be responsible for providing QA support of clinical programs at Acceleron. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Research, Non-Clinical Development, and other functions to establish and document risk-based GCP processes and procedures. The AD of Clinical QA will ensure compliance with applicable regulations with regards to sponsor oversight of Acceleron’s clinical programs.

What will you be doing?

  • Serve as the GCP QA Program Lead while working with internal & external stakeholders to ensure overall compliance with the protocol, study documents, and global regulatory requirements.
  • Serve as the expert GCP consultant for issue management & issue escalation, with a focus on critical and major quality events.
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide assessment of the impact of any deficiencies.
  • Work with internal customers and develop and execute strategic audit plans based the specific program needs
  • Support the development and/or review of audit agendas, audit reports, and CAPA’s for external audits.
  • Support the internal audit program as needed.
  • Participate in preparations for regulatory inspections, which may include reviewing Inspection Readiness Planning, Mock Inspections, and risk-based management of program inspection quality events.
  • Support investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities
  • Create or improve processes to ensure compliance with GCP regulations
  • Review/Revise/Author standard operating procedures (SOPs) as needed

What are we looking for?

  • GCP QA professional with late-stage program management experience and a proven track record of demonstrating good judgement & decision-making experience.
  • Ability to concisely present quality events and criticality to internal stakeholders.
  • Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues.
  • Well-prepared, competent, and confident when interacting with senior management, regulatory authorities, and internal and external partners
  • Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups.
  • Experience with developing & implementing GCP QA systems, processes, and procedures.
  • Ability to remain objective/autonomous in implementing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
  • Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
  • Strong working knowledge of GCP for drug/device covering all phases of clinical study program (Phase I to IV).
  • Conducted GCP audits and actively participated in regulatory inspections.
  • Strong experience in IND and CTA filings; NDA/BLA/MAA experience strongly preferred
  • Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred
  • Minimum of 10-12 years of relevant experience in a biotech/pharmaceutical setting with at least 5 years of GCP Quality Assurance experience

How will you grow with us?

This candidate will advance Acceleron’s innovative pipeline through proactively developing and influencing quality specific standards. As the pipeline progresses, this candidate will increase their strategic planning skills to align pipeline progression to the regulatory climate and global footprint.

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.



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$119,074 Low Average $134,886 High $150,697

Understand the total compensation opportunity for Associate Director, Clinical Quality Assurance at companies like ACCELERON PHARMA INC, base salary plus other pay elements

Average Total Cash Compensation

Includes base and annual incentives

The chart shows total cash compensation for the ACCELERON PHARMA INC Associate Director, Clinical Quality Assurance in the United States, which includes base, and annual incentives can vary anywhere from $119,074 to $150,697 with an average total cash compensation of $134,886. Total compensation includes the value of any benefits received in addition to your salary and some of the benefits that are most commonly provided within a total compensation package including bonuses, commissions, paid time off, and Insurance. The total cash compensation may get paid differently by industry, location, and other factors.
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