Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.
We are seeking a self-starting, enthusiastic candidate with extensive knowledge of Quality Assurance and Quality Control methods. The incumbent will develop Quality Management Systems (QMS) and Quality Control processes at the Breda, NL site. The incumbent will also be responsible for maintaining the day to day activities to support product manufacture, batch record issuance, test and release including deviation support, OOS support and root cause analysis
Provide and lead quality compliance through training; foster a quality-oriented culture
Manage the Quality Documentation system and archival process, maintain employee training
Manage the daily Quality activities of finished OPUS® column products from incoming raw material release through batch record review and release of finished goods.
Establish and maintain a QC microbiology laboratory by building a robust microbiological system through ISO cleanroom cleaning validations, RODI water monitoring, and environmental monitoring and trending. Bioburden, endotoxin and FTIR resin testing will be required.
Lead/administer audits of systems, processes and products to ensure compliance with ISO and customer requirements and compliance to the Quality System. H of customer and ISO registrar audits.
Maintain supplier management program and qualifications including an annual critical supplier evaluation
Oversee the complaint handling process through maintenance of complaint handling requirements, processes, and closure
Coordinate/track/drive closure of audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
Design, compile, analyze, trends and issue QA and QC performance metrics reports. Present summaries to the senior management team during Management Review
Review and or approve IQ/OQ and Validations of critical processes and equipment
Manage and develop QA and QC staff members; plan and implement QA and QC resources to support quality related activities
Write and implement standard operating procedures and work instructions for QA and QC procedures
Complete customer questionnaires, surveys, and review customer Confidentiality and nondisclosure agreements
Demonstrated ability to foster a Quality Culture across the organization
Bachelor’s degree in Engineering, Biology or Chemistry degree required.
Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. Microbiology experience required.
Minimum 4 years of experience mentoring and supervising direct reports.
Highly organized and strong attention to detail
Enthusiastic, team player, collaborative across all departments to achieve the common goals.
Experience leading Quality audits both internally and externally; lead auditor certificate preferred.
Experience with LEAN implementation strongly preferred.
Experience with SAP, Canea One, Salesforce and electronic document control systems
Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software