GCP Auditing Manager
Proclinical is currently recruiting for a Good Clinical Practice Audit Manager for a global pharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for supporting the overall execution of the overall Internal Suppler & Audit (ISA) strategy and ensure adherence to R&D QA & Compliance (QA&C) Operational objectives.
- Provide coordination and support in execution of overall ISA strategy and R&D QA&C Operational objectives
- Manage and oversee external auditors
- Administrator and/or User for ISA Systems: Supplier Database and SharePoint
- Provide support for QA & Compliance Regulatory Agency Inspections
- Provide professional expertise and leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk R&D Business Partners and Shire.
- Liaise and network with internal and external business partners to implement ISA strategy
- Lead or Co-Lead the planning, execution and close out, of assigned ISA audits
- Auditor and/or co-auditor assigned ISA audits
- Manage ISA driven CAPAs, effectiveness checks, and issue escalation
- Support management of ISA database as needed
- Lead or support ISA facilitated meetings.
- Participate in QA&C project initiatives (System Development and COE driven).
Skills and Requirements:
- BS in a life science or equivalent experience; Graduate degree in a scientific discipline or program management a plus
- 5+ years' of pharmaceutical experience, global exposure preferred
- Ideal candidate will have broad experience in product development, regulatory compliance, supplier management, database and system administration, and GCP auditing.
- Strong knowledge and/or awareness of local and international regulations. Maintains awareness of newly published regulations.
- Proficient knowledge of MS Word, Excel, Access, PowerPoint & Outlook; working knowledge of Trackwise a plus.
- Collaborative team player who has the ability to think and act quickly and identify creative solutions
- Project management skills with a focus on attention to detail
- Leadership skills, and ability to inspire colleagues
- Excellent communication and interpersonal skills.
- A self-starter, who motivates, has tact and diplomacy and is able to define and prioritize tasks within a project
- Ability to foster and balance a culture of compliance within a culture of innovation
- Ability to influence without authority, in a matrix environment
- Understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GCP and internal process auditing
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Bad Homburg vor der Höhe (61348), Germany
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