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

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.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com