Full-time Associate Director of R&D Quality and Compliance Auditing needed at a top biotech company in Boston!
Job Description: The Associate Director, R&D Audit has primary ownership for the GCP Audit program. S/he has audit management responsibilities, independently leading the planning, conduct and reporting of internal and external audits to assure adherence to internal standards, and compliance with regulatory requirements and guidelines. S/he provides direction and oversight of vendor auditors to enable timely execution of audits and review and approval of audit reports and responses. Note: this role is not responsible to conduct audits.
This position is office-based and will not be performing audits or traveling. Successful candidate may have been an auditor in the past.
* Must have GCP (Good Clinical Practice), inspection, & quality experience
* Reports to Director of R&D Compliance
* Will have 2 direct reports:
- Sr Manger of R&D Audits
- 1 Contractor/ analyst
* Will be responsible for engaging with stakeholders about where compliance and auditors should focus
* Will create audit plans - seeking candidates who have been in a role like this before at a big pharmaceutical or biotech company
* Works cross-functionally with safety & regulatory people, data scientists & biostaticians
- Bachelor’s Degree required, Masters/PhD optional – Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.
- 8+ years pharmaceutical or biotechnology drug development experience.
- 5+ years Quality Assurance or Compliance experience.
- 5+ years of audit or audit management experience.
- Knowledge of international GxP drug development regulations, including USA (FDA), EU (EMA, MHRA), Japan (PMDA), and ICH Guidelines.
- Demonstrated ability to establish effective business relationships with and provide oversight of vendor partners.
- Strong leadership and communication skills. Excellent negotiation and problem-solving skills.
- Working knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and audit management systems.
- High attention to detail including proven ability to manage multiple, competing priorities.
Offering competitive compensation, complete benefits, and relocation assistance!
For more information, please submit your resume for review or email it to me directly: