Senior Quality Compliance Specialist
Proclinical is currently recruiting for a Senior Quality Compliance Specialist for a global biotechnology company located in Cambridge, MA. Successful candidate will be responsible for the management and oversight of external auditors.
- Provide coordination and support in execution of overall ISA strategy and R&D QA&C Operational objectives
- Proactively identify potential areas of non-compliance and risk to R&D Business Partners
- Provide support in the planning, execution and close out of assigned ISA audits and related communications
- Support the development and coordination of audit plans and assignments
- Escalation of potential issues with suppliers to appropriate personnel
- Support ISA facilitated meetings
- Participate in QA&C project initiatives (System Development and COE driven)
External Auditor Oversight
- Develop and manage relationships with external auditor partners
- Manage the active and approved auditor pool and provide recommendations based on ISA requests
- Manage master service agreements and associated addendums with external auditor partners
- Develop consultants statements of works for ISA audits; collaboration with external business partners on amendments
- Support QA&C as needed in the identification, preparation and management of external auditors
ISA/QA&C Supplier Database & SharePoint Management
- Maintain and manage ISA/QA&C database and SharePoint site
- Collaborate with internal business partners to implement required database and SharePoint updates
- Assist and/or provide training on ISA/QA&C database and SharePoint as necessary
- Serve as designated ISA/QA&C database and SharePoint super-user
Regulatory Agency Support
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections
Skills and Requirements:
- Bachelor's degree in a relevant discipline or equivalent experience
- Exposure working in pharmaceutical industry a plus
- Ideal candidate will have experience in product development, regulatory compliance, supplier management, database and system administration, and/or GxP auditing
- Proficient knowledge of MS Word, Excel, Access, PowerPoint & Outlook; working knowledge of Trackwise a plus
- Strong attention to detail with the ability to articulate quality related risks and potential impact
- Collaborative team player who has the ability to think and act quickly and identify solutions to problems
- A self-starter, has tact and diplomacy and is able to define and prioritize tasks within a project
- Excellent communication and interpersonal skills
- Basic understanding of the: drug development processes, clinical development operations, vendor outsourcing and procurement processes, regulatory affairs, GXP and internal process auditing
- Works on problems of diverse scope requiring data analysis and evaluation of identifiable factors
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions
- Participates in determining objectives of assignment. Plans schedule and arranges own activities in accomplishing objectives
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.