Full-time Associate Director of R&D Quality and Compliance Auditing needed at a top biotech company in Boston! (Reference Code: KAM)
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 Biogen’s 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
Qualifications: - 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!!
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