Job 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.™

Basic Purpose:
The Compliance Specialist – Quality Services is responsible for ensuring site compliance with applicable regulatory requirements, including 21 CFR Part 11, ICH Q7, and global data integrity standards, through the validation and lifecycle management of computerized systems.Working collaboratively across Quality, Manufacturing, and Information Technology, this individual will contribute to the deployment, validation, maintenance, and governance of systems that support Quality Assurance, Quality Control, and Operations. The role requires application of risk-based validation methodologies and lifecycle management principles to ensure that computerized systems remain fit for intended use and inspection-ready.This position also serves as a key contributor to system implementation initiatives and ongoing compliance activities, including ownership of validation deliverables and oversight of system changes.Essential Functions and Responsibilities:

• 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

Knowledge, Skills, Qualifications and Physical Requirements:Education and Background

• 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

Technical Expertise

• 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
  
  

Core Competencies

• 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

Equipment and Applications:

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

Work Environment and Physical Demands:

• 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