Operational QA

GSK•King of Prussia, PA

5d•Onsite

About The Position

The Operational QA will perform the quality assurance activities and quality oversight for the manufacturing of Drug Substance at Upper Merion R&D Pilot Plant. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and incorporate effective processes and procedures in Quality R&D Operations for Drug Substance and Cell Banking manufacturing. Approve GMP documentation, including Standard Operating Procedures, pre and post approve batch records, validation documentation, change controls, and other controlled documents from business partner areas. Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Quality R&D and business units regionally and globally. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. And other duties as assigned

Requirements

Bachelor’s degree
5+ years of experience in Quality roles OR in a highly regulated environment (EMA/ FDA/ MHRA) and manufacturing operations
Large Molecule experience

Nice To Haves

Problem solving and negotiation skills
Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest
Ability to drive change and continuous improvement
Ability to communicate complex information both orally and in writing
Fluency in English both written and spoken

Responsibilities

Develop and incorporate effective processes and procedures in Quality R&D Operations for Drug Substance and Cell Banking manufacturing.
Approve GMP documentation, including Standard Operating Procedures, pre and post approve batch records, validation documentation, change controls, and other controlled documents from business partner areas.
Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Quality R&D and business units regionally and globally.
Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
Other duties as assigned.