Senior Associate, Quality and Compliance

Role Overview

The Senior Associate, Quality and Compliance, will take primary responsibility for supporting Xiromed's commercial product compliance. The Senior Associate of Quality will have direct oversight of Xiromed's US Portfolio, which consist of a diverse range of products, including internally and externally manufactured sterile drugs;
Drug/Device combination products, Topicals, and complex oral solids.

The Senior Associate will contribute to the Global Quality Systems team with emphasis on global harmonization. The role will have three primary focus areas; U.S. Quality Systems metrics reporting, Quality Compliance (Non-conformance/Investigation, Corrective Action/Preventive Action, Change Control, Product Complaints), and Quality Systems administration (i.e. regulatory inspection support, documentation, etc.)

The Senior Associate will work closely with different departments including and are not limited to;
Supply Chain, Regulatory, R&D, Alliance Management, Exeltis USA Quality as needed and Commercial Operations to support new product launches and new and existing third-party manufacturing relationships.

Primary

Duties & Responsibilities

• Under direct supervision of Site Quality Head or designee will work with local and global Quality Assurance units to ensure Non-conformance/Investigation, Corrective Action-Preventive Actions (CAPA), and Change Control (CC) are reviewed, tracked, and closed. Quality System Metrics are collected for global quality assessment.
• Provide quality oversight to third party Contract Manufacturer Organizations (CMOs), to ensure the following are adequately reviewed/approved.
  • Batch Records review
  • Annual Quality Product Reports
  • Timely Market Release of US Products
  • Support supplier audits
• Provide support to site Standard Operating Procedures and support Site Quality Head or designee to manage training records
• Point of contact for local Quality System administration, documentation, and electronic organization of copied/archived documents.
• Support Regulatory Inspection readiness and provide audit administrative support
• Manage product complaints and monthly reconciliation
• Support Site Quality Head or Designee to Oversee and manage for routine market release, Change Management, Complaint Management and Annual Product Reviews.

Additional

Duties & Responsibilities

• Maintain stability tracking program on products
• Contribute to a productive working relationship with all business partners sites and cross-functional areas
• Have a positive and creative solution mindset for addressing complex compliance situations.

Requirements and personal skills

• Education:
  
  Undergraduate degree in technical or life science or equivalent years of experience.
• Languages:
  
  Spanish helpful
• Experience (years/area): 5-10 Years
• Travel:
  Limited Travel
• Personal skills:
  Please list all that apply General management skills, strong interpersonal and people development skills, ability to anticipate problems and solve them successfully.

Physical Demands

This job is a hybrid-role, and the expectation is to be in the office two days per week. This role routinely uses standard office equipment such as computers, phones, printers, etc.

Travel:
Domestic and International Travel required
-10%

Position Type and Expected Hours of Work:
This is a full-time position. Days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.