Job Description
Job Summary: Quality Assurance for Large Molecule Manufacturing plant ( Drug Substance)
The individual hired for this role will support a technical team interfacing between our Company and External Partners in the Biologics Drug Substance and Drug product manufacturing area. This individual will be responsible for ensuring that all quality assurance processes, and compliance requirements are met during technical transfers to and from External Partners and throughout the continuous commercial manufacturing process at External Partner sites.
Key Responsibilities:
· Quality Oversight: Report to the Quality lead (or delegate) and provide general direction on quality goals and objectives, functioning independently to ensure oversight of all quality-related issues at External Partner site.
· Regulatory Compliance: Ensure that all quality assurance activities comply with regulatory requirements (FDA, EMA, etc.) and internal quality standards throughout the product lifecycle, including during facility start-up and technical transfers.
· Manufacturing Support: Provide ongoing quality support to External Partners by resolving quality issues, performing proactive analysis of process performance, and developing plans to ensure compliance and quality meet capacity needs.
· Collaboration: Work collaboratively with Biologics Quality Operations and other relevant teams within the Focused Factory to support the product lifecycle and address quality-related matters.
· Validation Strategies: Support and oversee validation strategies for new and existing products, ensuring compliance with best practices in quality assurance.
· Technical Review: Conduct a calibrated technical review of External Partners’ process change requests, deviations, protocols, and Master Batch Record changes to ensure compliance with quality standards.
· Issue Resolution: Troubleshoot quality-related manufacturing issues and support investigations using scientific problem-solving methodologies.
· Efficiency Improvement: Work with Operations, Quality, and External Partners to develop more efficient methods to meet regulatory requirements while ensuring quality standards are upheld.
· Quality Management System: Ensure adherence to the highest quality, compliance, and safety standards by participating in and complying with our Manufacturing Division Quality Management System requirements.
· Partner Engagement: Collaborate with External Partners to achieve business goals while fostering a common culture that prioritizes quality and compliance for both organizations.
Education Minimum Requirement:
· Bachelor’s or master’s degree (or equivalent) in Chemical/Biochemical Engineering, Biotechnology, Microbiology, Pharmaceutical Science, Life Sciences, or a related field.
Required Experience and Skills:
· Proven experience in highly regulated manufacturing environments with a minimum of 15 years of experience in quality assurance within biopharmaceutical operations, particularly related to Drug substance and drug product manufacturing and validations.
· Strong knowledge of quality systems, regulatory compliance, and quality assurance practices in the biopharmaceutical industry.
· Familiarity with change management processes and regulatory support planning.
· Experience in process validations, cleaning validations, and the associated quality documentation requirements.
· Proficiency in large molecule manufacturing, in process controls, analytical testing, validations, batch records review and release.
· Ability to perform risk assessments and develop strategies for continuous improvement initiatives.
· Proficient in computer system validations, equipment validations, area qualification, Audits, batch release procedures.
· Effective communication skills for managing partnerships and addressing quality concerns.
Preferred Experience and Skills:
· Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality.
· Experience with quality management software and metrics analysis to drive performance
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Relocation:
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