Quality Assurance Batch Release Lead

Role Summary

QA Batch Release Lead responsible for leading and driving quality over the batch release process to market for the Swiftwater Site. Provides leadership and direction for quality oversight of vaccine drug product manufacturing and acts as the Business Owner for Release processes.

Responsibilities

• Overseeing the batch release process to ensure compliance with regulatory requirements and company standards
• Overseeing review and approval of batch records and associated documentation
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Conducting risk assessments and implementing mitigation strategies for batch release processes
• Coordinating actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities
• Investigating and resolving issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
• Participating in internal and external audits and inspections
• Collaborating with regulatory affairs to ensure compliance with local and international regulations
• Monitoring and analyzing batch release performance metrics
• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
• Participating in Quality Alert/Product Alert meetings and ensuring investigations and actions allow disposition of lots
• Representing the site in the CoP and, if requested, participating in the CoE and ensuring local communication
• Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report)
• Manage all batch release activities including Final Release, Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable

Qualifications

• Bachelor's Degree in Life Sciences or Engineering or equivalent
• 5 years of experience in a QA role within the pharmaceutical industry, with a focus on batch release processes
• Strong knowledge of GMP and quality assurance principles
• Strong leadership experience - managing/developing high-performing teams in a matrix environment
• Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards
• Proficiency in analyzing batch release performance metrics and identifying areas for improvement
• Capability to investigate and resolve issues or deviations related to batch release processes efficiently
• Experience in managing multiple tasks and projects simultaneously
• Take the Lead Behaviors

Skills

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in QA activities
• Strong verbal and written communication skills for interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing corrective actions
• Ability to manage multiple projects simultaneously with timely completion
• Fluent English; local language fluency may be required
• Knowledge of Swiftwater Plant operations
• Ability to lead and influence at all levels
• High level of autonomy
• Strong computer literacy (Excel, PowerPoint, Word)

Education

• As listed in Qualifications

Additional Requirements

• Occasional travel or site presence as required for batch release activities and audits (if applicable)