- Job Level:
Under the direction of the Director, Quality Management (U.S.), the Quality Management Specialist will be responsible for supporting US generic drug compliance and product market releases. The Quality Management Specialist will contribute to the Global Quality Systems team with emphasis on global harmonization process. 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.).
- 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 subsidiary site management review.
- 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
- Provide support to site Standard Operating Procedures and 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
- Maintain stability tracking program on products
- Contribute to a productive working relationship with all business partners sites and cross-functional areas
- Positive, creative solution mind set for addressing complex compliance situations.
Undergraduate degree in technical or life science or equivalent years of experience
Experience & Skills Required
- At least five years’ experience in Quality Assurance/Quality Management Systems and Compliance within biopharmaceutical/medical device industry
- Languages: English, Spanish is a plus
- Track record of successful cross functional partnership with CMOs and matrix organizations
- Specific Knowledge: Data analysis skills and experience is required
- Personal skills: Strong interpersonal skills, ability to anticipate problems and solve them successfully.
- Track record of resolving compliance issues
- Track record of excellent technical and communication skills, and the ability to work independently
- Regulatory inspection experience highly desirable