Senior Quality Systems Specialist

The Senior Quality Systems Specialist supports the quality systems framework for the GlycoMimetics GMP and GCP activities by documenting and managing quality systems records and activities to support the management of outsourced GMP manufacturing and clinical operations. Activities include building, enhancing, and refining/optimizing the quality systems and processes. Works under general supervision.

Job Duties:

• Implements, maintains, and refines the company Quality Systems to support GMP manufacturing and clinical operations
• Coordinates deviations from processes, analytical methods, and protocols to assure that identified deviations are documented and investigated in a thorough and timely manner to meet production and product release timelines. Assists with the process to investigate (Root cause analysis), document, review, approve and communicate the status of deviations for internal and outsourced activities
• Coordinates change controls related to processes, analytical methods, and specifications to assure that identified changes are documented, justified, assessed and approved. Assists with the process to document, review, approve, and communicate the status of changes for internal and outsourced activities
• Verifies that CAPAs are proactively identified, documented, tracked, and implemented
• Oversees the vendor qualification program including the use risk-based tools for vendor assessments, management of the vendor audit schedule, oversight of audit activities (preparation and management), and vendor performance monitoring. May assist with drafting Quality Agreements
• Coordinates the site internal audit program to verify compliance with GXP regulations, international guidelines and internal requirements
• Administers the electronic Document Management and Training Management systems
• Manages the regular exchange of Quality System information with external business partners
• Interacts with functional areas (e.g., Technical Operations, Clinical Operations ) to verify compliance with regulatory requirements and good documentation practices
• Tracks trends and performance metrics and participates in periodic reviews to ensure suitability and effectiveness of the Quality System. Finds opportunities for improvement, identifies and implements appropriate practices and programs
• Complies with all applicable policies regarding health, safety, and environmental policies

J ob Requirements:

• BS chemistry, engineering, or related life science field and at least five (5) years relevant experience in pharmaceutical Quality Assurance, cGMP manufacturing or similar environment
• Must have thorough knowledge of GMP regulations, 21 CFR Part 11, 211 and 210, FDA/ICH guidelines, and GLP regulations
• Strong background in analytical methods, testing, and related instrumentation is a plus
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward
• Proven organizational skills and ability to handle multiple projects simultaneously while meeting deadlines; attention to detail
• Ability to interact in a collaborative manner with colleagues and vendors
• Excellent oral and written communication skills with strong technical writing experience required
• Some travel may be required domestic and international [less than 10%]

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