Job Details

This position will ensure that our company's quality management system complies with industry standards and regulations. The Quality Systems Manager will also be responsible for administering quality control procedures that include but are not limited to Document Management, Training Administration, CAPA, Change Management, Deviations, Complaint Handling, and Audit Programs.

Essential Job Functions:

• Perform complex manufacturing formulation batch production record and test data reviews and approval in support of product release in accordance with specifications and SOPs.
• Monitor various stages of processing along with the appropriate paperwork in compliance with specifications.
• Draft and review specifications, batch records and SOPs.
• Review and approve discrepancy reporting, investigations and CAPAs associated with incoming, in process and production batch processing, release and stability testing, and product complaints.
• Review and approve Change Control records.
• Monitor and trend quality metrics and provide senior management with relevant KPI data.
• Manage document control processes in an electronic document management system (EDMS) in compliance with internal procedures and policies, as well as regulatory requirements.
• Manage the routing, review, approval, distribution and archival of new and revised controlled documents.
• Establish and maintain records management system including secured storage, retrieval, retention, and destruction.
• Managing training documentation within an electronic training system.
• Participates in Regulatory Authority Inspections, internal audits, and external audits, as required.
• Provide guidance and direction to less experienced staff.

Competency (Knowledge, Skills, and Abilities):

• Excellent oral and written communication skills.
• Demonstrated ability to be productive and successful in an intense and changing work environment.
• Has wide ranging experience and is able to use Quality concepts and company objectives to resolve complex issues in an effective manner.
• Takes initiative in making improvement suggestions to promote operational goals on a consistent basis
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Strong attention to detail.

Personal Performance Factors:

• Demonstrates strong work ethic.
• Shows initiative and holds themselves accountable.
• Lives and advances the Neurelis culture and values.
• Always operates with a high degree of integrity and tact.
• Demonstrates sound judgment and decision-making ability.

Management Responsibilities and Skills (if applicable):

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Spends approximately 90% of work time sitting and meeting with others or working at a desk and/or computer. Spends approximately 10% of work time standing or walking within the work area or at meetings and bends, twists, stoops and reaches. Ability to communicate verbally and in writing. Occasionally lifts and/or moves up to 10 pounds. Working conditions are normal for an office environment. The noise level is usually moderate.

Travel Requirements:

• Ability to travel up to 20%

Minimum Education and Experience Required:

• Bachelor's degree required or equivalent experience in a healthcare related field.
• Minimum of 8+ years of Quality Assurance, Regulatory Affairs Regulatory Operations, Quality Systems/Document Control or Technical Writing experience.
• Experience with Quality Systems software and electronic publishing software (e.g. Veeva Vault, IQVIA RIM Smart, etc.).
• Experience working in biotechnology or pharmaceutical industry.
• Strong technical expertise of QA, Manufacturing, and Supply Chain processes to support development and maintenance of cGMP compliant quality systems.
• Understands and can use problem solving tools such as Risk Analysis, Root Cause Analysis and FMEA.
• Understanding of ICH/GxP regulations and general knowledge of document management, manufacturing, or clinical processes.
• Extensive experience with Microsoft Word preparing technical documents.

Preferred Education and Experience:

• Knowledge of GPP training documentation and requirements preferred.
• Knowledge of GCP and GLP regulations preferred.
• Working knowledge of Excel and PowerPoint preferred.