Compliance Specialist, Quality Services

Cosette Pharmaceuticals•Lincolnton, NC

1d•Onsite

About The Position

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.™ 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.

Requirements

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

Nice To Haves

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

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