Quality Specialist, Change Control Management

Job Title: Quality Specialist, Change Control Management

Location: Wilson ,NC

Duration:06 months on contract

Description:

Position Summary

The Quality Specialist, Change Control Management, is responsible for the administration, oversight, and continuous improvement of the pharmaceutical Change Control Program. This role ensures that changes to facilities, equipment, processes, computerized systems, materials, specifications, and quality systems are evaluated, documented, approved, implemented, and closed in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, ICH guidelines, and company quality standards.

The position partners cross-functionally with Manufacturing, Engineering, Validation, Supply Chain, Regulatory Affairs, and Quality Control to assess impact, manage risk, and ensure successful implementation of changes while maintaining product quality, patient safety, and regulatory compliance.

Key Responsibilities

Change Control Management

• Lead and coordinate change control activities throughout the change lifecycle.
• Review, assess, and process change control records for GMP systems, processes, facilities, equipment, materials, utilities, and documentation.
• Facilitate impact and risk assessments to determine potential effects on product quality, regulatory filings, validation status, and patient safety.
• Ensure appropriate stakeholders review and approve proposed changes.
• Track change controls to ensure timely implementation and closure.
• Escalate overdue or high-risk changes to management.

Regulatory Compliance

• Ensure compliance with FDA and other applicable regulatory requirements.
• Maintain adherence to cGMP regulations, including 21 CFR Parts 111, 210, 211, and applicable ICH guidance.
• Support inspection readiness activities related to change management processes.

Risk Management

• Facilitate Quality Risk Management activities utilizing tools such as FMEA, risk ranking, and risk assessments.
• Evaluate potential regulatory and validation impacts of proposed changes.
• Ensure risk mitigation actions are identified, implemented, and documented.

Cross-Functional Collaboration

• Partner with Manufacturing, Validation, Engineering, Quality Control, Regulatory Affairs, and Supply Chain teams to execute changes effectively.
• Coordinate implementation activities and ensure completion of required deliverables.
• Support project teams by providing guidance on change control requirements and best practices.

Quality Systems Support

• Review related quality system records including deviations, CAPAs, qualification protocols, and validation documentation.
• Verify completion of effectiveness checks and post-implementation activities.
• Identify opportunities for continuous improvement within the Quality Management System (QMS).

Metrics and Reporting

• Generate and analyze change control metrics and key performance indicators.
• Trend data to identify recurring issues and process improvement opportunities.
• Prepare management reports and quality review presentations.

Training and Mentorship

• Train site personnel on change control procedures, GMP requirements, and quality system expectations.
• Provide guidance and coaching to process owners regarding change management best practices.

Required Qualifications

Education

• Bachelor''s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related scientific discipline.

Experience

• Minimum 3-5 years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum 2-3 years of direct experience managing pharmaceutical change controls.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva Vault (preferred), TrackWise, MasterControl, ComplianceWire, or similar systems.

Technical Knowledge

• Strong knowledge of:
• cGMP regulations (FDA, EU GMP)
• ICH Q7, Q9, Q10 guidelines
• Data Integrity principles (ALCOA+)
• Validation and qualification processes
• Risk management methodologies
• Pharmaceutical manufacturing operations
• Deviation and CAPA management systems

Preferred Qualifications

• Certified Quality Auditor (CQA), ASQ Certification, or equivalent.
• Experience supporting regulatory inspections.
• Knowledge of computerized system validation (CSV) and Annex 11 requirements.
• Experience with oral solid dosage manufacturing.
• Lean Six Sigma certification or continuous improvement experience.

Key Competencies

• Change Control Subject Matter Expertise
• Quality Systems Management
• Regulatory Compliance
• Risk Assessment and Mitigation
• Technical Writing
• Project Management
• Problem Solving and Root Cause Analysis
• Attention to Detail
• Cross-Functional Collaboration
• Effective Communication and Influencing Skills
• Time Management and Prioritization

Success Measures

• On-time change control closure rate
• Reduction in overdue change controls
• Inspection and audit readiness
• Quality system compliance metrics
• Effective implementation of risk mitigation plans
• Sustained regulatory compliance and product quality performance

This role serves as a critical quality partner, ensuring that all GMP changes are appropriately assessed, approved, implemented, and documented while maintaining compliance, operational excellence, and patient safety.

Contact:

Jaya Balaji: jayabalaji.s@sunrisesys.com | (732) 515-5373 | URL: www.sunrisesys.com