K.A. Recruiting


Associate Director - R&D Quality and Compliance Auditing (GCP)

Boston, MA 02115

Job Type: Laboratory Jobs Job Number: KAM108191

Job Description

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!!
For more information, please submit your resume for review or email it to me directly:  katherine@ka-recruiting.com

Additional Information

Please click APPLY ONLINE or email us a copy of your resume directly (my email is next to my profile). Be sure to check out all of our jobs at http://jobs.ka-recruiting.com. We look forward to working with you!

Meet Your Recruiter

Katherine Marano
Healthcare Recruiter

Katherine recruits and places healthcare professionals into full time permanent positions across the country. She works closely with laboratory professionals, and would love to address your hiring needs and help fulfill your career goals!

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