Nephron Pharmaceuticals · 16 hours ago
Production Change Control Manager
West Columbia, SC
Full-time
Onsite
Senior Level
5+ years expNephron Pharmaceuticals is a company focused on manufacturing operations, and they are seeking a Production Change Control Manager to oversee and manage change control activities. This role involves ensuring compliance with FDA regulations and cGMPs while maintaining product quality and safety through effective change management processes.
BiotechnologyHealth CareManufacturing
Responsibilities
Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and company quality policies
Facilitate the review, coordination, and approval of change records related to manufacturing processes, equipment, facilities, materials, utilities, and production systems
Evaluate and facilitate review of proposed production changes to assess potential impact on product quality, process performance, validation status, regulatory filings, and compliance
Ensure all changes are thoroughly documented, including change requests, impact assessments, risk assessments, implementation plans, and effectiveness checks
Ensure change controls are appropriately linked to validation, qualification, calibration, maintenance, and training requirements, as applicable
Review controlled documents (SOPs, batch records, work instructions, forms, and labels) to ensure accuracy, completeness, and compliance with approved production changes
Participate in Change Review Board (CRB) meetings, including presentation of production change metrics, trends, and KPIs
Present quarterly change control trends and performance metrics at Quality Management Review (QMR) meetings
Investigate and resolve issues or delays related to change control approvals by collaborating with cross-functional stakeholders
Monitor the effectiveness of production change implementations and identify opportunities for process improvement
Ensure data integrity, traceability, and accuracy of all change control records
Support manufacturing initiatives, campaigns, and special projects requiring change control oversight
Communicate quality-related risks, issues, or noncompliance related to production changes to Quality Management or designee
Participate in continuous improvement efforts to enhance the efficiency and effectiveness of production change control processes
Perform other duties as assigned or required to support manufacturing and quality objectives
Support and participate in customer, internal, and regulatory audits and inspections, specifically related to production change control
Educate and train manufacturing and support personnel on production change control procedures, documentation standards, and best practices
Conduct system access and change control training for new production and support employees
Periodically review production change control activities and metrics to identify trends, risks, and improvement opportunities
Qualification
Required
Strong technical background with solid knowledge of Quality Assurance, cGMPs, FDA regulations, and QMS-based change control systems
Hands-on experience managing production change controls within electronic Quality Management Systems (eQMS)
Excellent written and verbal communication skills with strong interpersonal abilities
Strong analytical, critical-thinking, and problem-solving skills, with high attention to detail and data integrity
Ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced manufacturing environment
Ability to work independently and collaboratively across cross-functional teams
Proficient in technical writing and use of Microsoft Word, Excel, and Adobe Acrobat
Demonstrates professionalism, integrity, and discretion in handling confidential quality and regulatory information
Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required
5+ years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or related industry)
3+ years of hands-on experience managing change control within a QMS or electronic QMS (eQMS)
Demonstrated experience evaluating changes to manufacturing processes, equipment, facilities, utilities, and materials
Working knowledge of cGMP, FDA regulations, and quality systems governing production operations
Experience supporting regulatory inspections, customer audits, and internal audits
Proven ability to collaborate with Manufacturing, Engineering, Validation, Maintenance, and Quality teams
Preferred
Advanced degree or Quality/Regulatory certification (e.g., ASQ, CQE, CQA) preferred
Experience leading or participating in Change Review Boards (CRB) and presenting change control metrics or KPIs preferred
Company
Nephron Pharmaceuticals
Nephron Pharmaceuticals Corporation is a mid-sized company that manufactures generic respiratory medications.
501-1000 employees
H1B Sponsorship
Nephron Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$775MKey Investors
WhiteHawk Capital Partners
2025-01-10Debt Financing· $350M
2023-09-15Private Equity· $350M
2014-08-07Debt Financing· $75M
Leadership Team
B
Bryan Beck
Chief Technology Officer
A
Ashley Daugherty
Chief Scientific Officer
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase