Senior Quality Compliance Specialist

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.