Senior Director, Head of Quality Assurance

Atrium is a biopharmaceutical company pioneering delivery of RNA therapeutics to the heart to transform the standard of care for people living with cardiomyopathies. Our proprietary technology leverages the targeted RNA delivery platform initially designed at Avidity, which combines the tissue selectivity of mAbs and other targeted delivery ligands with the precision of oligonucleotides.

This unique combination is designed to allow selective targeting of the underlying genetic drivers of disease that were previously undruggable. Through targeted, non-viral delivery of siRNA to cardiac tissues, our approach has the potential to overcome key limitations of nonspecific viral and nanoparticle-based delivery systems, including challenges related to tissue specificity, immunogenicity, and redosing.

Job Summary:
The Senior Director, Head of Quality Assurance will lead quality strategy and compliance activities across GCP, GLP, and GMP for Atrium’s advancing pipeline. This role is responsible for ensuring adherence to global regulatory requirements, implementing robust quality systems, and driving training and compliance programs to support clinical and manufacturing operations. The ideal candidate will have extensive experience in quality assurance for clinical and manufacturing environments, strong leadership skills, and a proven ability to manage internal teams and external partners in a small biotech environment.

Job Responsibilities:

• Develop and lead QA strategy for GCP, GLP, and GMP compliance across all phases of development
• Oversee implementation and maintenance of quality systems, including SOPs, training programs, and compliance monitoring
• Ensure QA oversight of clinical trials, manufacturing operations, and vendor activities
• Manage internal QA team and provide leadership for quality-related initiatives
• Partner with Clinical Operations, CMC, Regulatory Affairs, and CMOs/CROs to ensure compliance with applicable regulations
• Lead inspection readiness activities and support regulatory inspections (FDA, EMA, and other authorities)
• Drive continuous improvement initiatives in quality systems and compliance processes
• Oversee training programs to ensure staff and vendor compliance with GCP, GMP, and other applicable standards
• Author and review QA-related sections of regulatory submissions, including INDs, amendments, and BLAs
• Identify and mitigate risks related to quality and compliance impacting clinical and commercial programs
• Ensure adherence to FDA, EMA, ICH, and Atrium policies and procedures
  
  
  
  
  

Education & Experience Requirements:

• Bachelor’s degree in life sciences or related field required; advanced degree preferred
• Minimum 10 years of pharmaceutical/biotech industry experience in Quality Assurance, with expertise in GCP and GMP compliance
• Proven experience managing QA teams and external partners
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH) for clinical and manufacturing operations
• Experience supporting regulatory inspections, authoring and reviewing Quality Agreements with third parties and authoring QA sections of submissions
• Excellent leadership, communication, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Demonstrated ability to build and maintain effective cross-functional relationships
  
  
  
  
  

Knowledge, Skills and Abilities:

• Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders
• Excellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership and other key stakeholders
• Proven ability to work independently and be self-motivated
  
  
  
  
  

What we Provide:

• The base salary range for this role is $264,000-$291,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors
• Atrium offers competitive compensation and benefits which include stock options, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and unlimited of time off including spring, summer & winter breaks
• A commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job-specific training offered by industry, and an education reimbursement program
  
  
  
  
  

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.