Qa Release Supervisor

GSK is currently looking for QA Release Supervisor to join our team in Cambridge, MA. The QA Release Supervisor is focused on support of releasing lots of internal GMP manufacturing to ensure compliance with all applicable regulations. This is a unique opportunity for an individual to work in a clinical/commercial stage Quality department and gain experience in many areas of Quality Assurance. The QA Release Supervisor will report to our Associate Director of Quality Assurance.
KEY RESPONSIBILITIES:

• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
• Act as the Quality Assurance subject matter expert for questions and issues related to product release and SAP utilization for release activities.
• Key contact for internal departments for lot release activities, liase with other sites (i.e QP) to ensure all applicable documentation is received for release activities
• Release internal GMP manufacturing lots per standard operating procedures
  • Ensure accurate and timely release of produced lots in SAP and/or paper based systems
  • Maintain visibility to produced material as it progresses through SAP and/ or paper based systems
  • Escalating known issues that will hold product from release
  • Ensuring consistent data packages for release- verifying completeness of documentation- ensuring 100% clarity on releasability of a lot
• Support master batch records, ensuring adherence to GSK internal procedures, policies, standards and FDA regulations
• Assist with impact assessment of site product deviations
• Support executed batch record review, when needed, to support lot disposition activities
• Review and approve quality systems (i.e deviations, CAPAs, change controls) in support of lot release
• Local owner for SOPs on release of internal manufactured lots

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in Chemistry, Biology, Engineering or related field
• 8+ years of industry experience in pharma/biopharma
• 5+ years of QA experience

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

• Experience with vaccines/biologics
• Experience with Good Documentation Practices including Batch record review
• Experience with review and disposition of clinical materials for human use
• Experience with SAP
• Knowledge of regulatory requirements
• Able to respond to changing priorities and expectations with a composed demeanor
• Ability to foster effective relationships with vendors and colleagues
• Excellent communication, writing and presentation skills for interfacing with internal and external organizations
• Strong collaboration and team skills
• Ability and desire to work in a fast-paced environment

• Ability to think through the process and accurately apply and adapt regulatory standards
• Helpful to understand the QA function with the ability to make decisions on a go / no go criteria
• The ability to work effectively within a variety of situations and adapt enthusiastically to changes in job demands
• Pursues tasks with energy, drive, and initiative; even in a fast-paced environment
• Comfortable in a results-driven, highly accountable environment where you can make an impact
• Builds productive working relationships across key groups
• Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure

#LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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