Senior Quality Compliance Specialist Job Description Template
Our company is looking for a Senior Quality Compliance Specialist to join our team.
Responsibilities:
- 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 the development and coordination of audit plans and assignments;
- Proactively identify potential areas of non-compliance and risk to R&D Business Partners Audit Coordination;
- Develop and manage relationships with external auditor partners;
- Manage master service agreements and associated addendums with external auditor partners;
- Provide support in the planning, execution and close out of assigned ISA audits and related communications;
- Support ISA facilitated meetings;
- Manage the active and approved auditor pool and provide recommendations based on ISA requests;
- Support QA&C as needed in the identification, preparation and management of external auditors ISA/QA&C Supplier Database & SharePoint Management;
- Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections;
- Maintain and manage ISA/QA&C database and SharePoint site;
- Develop consultants statements of works for ISA audits; collaboration with external business partners on amendments;
- Collaborate with internal business partners to implement required database and SharePoint updates;
- Escalation of potential issues with suppliers to appropriate personnel.
Requirements:
- 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;
- 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;
- Bachelor’s degree in a relevant discipline or equivalent experience;
- A self-starter, has tact and diplomacy and is able to define and prioritize tasks within a project;
- Exposure working in pharmaceutical industry a plus;
- Works on problems of diverse scope requiring data analysis and evaluation of identifiable factors;
- Excellent communication and interpersonal skills;
- Collaborative team player who has the ability to think and act quickly and identify solutions to problems.