Description

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.  Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success.  Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. 

Innovating every day.™

• Drive compliance of site computerized systems with applicable regulatory requirements, including electronic records, electronic signatures, and data integrity standards
• Plan, execute, and document validation activities for GxP systems using a lifecycle approach, including:
• Development of validation strategies and deliverables
• Execution of qualification testing (IQ/OQ/PQ)
• Preparation of summary and traceability documentation
• Develop and maintain validation documentation in alignment with internal procedures and recognized industry practices
• Oversee and maintain the site Computer Systems Master Plan, ensuring ongoing alignment with business objectives and regulatory expectations
• Support the rollout, configuration, and sustainment of computerized systems used within Quality and Operations (e.g., LIMS, Veeva)
• Act as system owner or administrator for designated platforms, including:
• Management of user roles and system access
• Oversight of system configuration and performance
• Resolution of system-related issues and user support
• Partner with cross-functional stakeholders to gather and define system requirements and ensure compliant implementation
• Evaluate proposed system changes for validation impact and ensure appropriate documentation and approval through the change control process
• Participate in regulatory inspections and internal audits by providing documentation and subject matter expertise related to computerized systems
• Promote awareness of validation and data integrity expectations through training and collaboration with site personnel
• Identify opportunities to improve system compliance, efficiency, and standardization across the site
• Function as system administrator for QC Laboratory equipment.
• Perform additional responsibilities as assigned

• Bachelor’s degree in a scientific, engineering, or technical discipline
• Minimum of five (5) years of experience supporting regulated systems within a GMP environment
• Demonstrate knowledge of cGMPs, Safety, and 21 CFR regulations/requirements
• Demonstrated involvement in validation of computerized systems

• Working knowledge of regulatory expectations governing computerized systems, including electronic recordkeeping and data integrity principles
• Familiarity with risk-based validation frameworks (e.g., lifecycle approach)
• Experience supporting laboratory, quality, or manufacturing systems such as LIMS, eQMS, or ERP platforms
• Understanding of system controls, including audit trails, user access, and electronic signatures
• Exposure to system implementation and post-deployment support activities
  
  

• Strong written communication skills, particularly in technical and compliance documentation
• Effective coordination and project execution capabilities
• Ability to manage competing priorities and deadlines
• Strong interpersonal skills with the ability to work across functional areas
• Analytical thinking and attention to detail
• Proactive approach to problem-solving and continuous improvement

•  eQMS (i.e. Veeva)
•  LIMS (i.e. LabVantage)
• Empower
•  SAP
•  Excel

• Use of personal protective equipment (PPE) as required in laboratory settings
• Occasional lifting of materials up to approximately 50 pounds
• Combination of office and laboratory environments

Equal Opportunity Employment

Providing “equal employment opportunity” is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.