Manager, Quality Control
Are you driven by quality and technical aspects of Quality Control?
Are you interested in working in Cell and Gene Therapy development and pre-clinical safety assessment studies to commercial products?
Read more below to learn about the responsibilities of this opportunity.
• Align with CGT Analytical Development to ensure that method development, equipment and processes enable successful transfer of fit for purpose analytical methods.
• Implement and maintain the quality control processes and procedures to support product development within GSK, collaborators and third parties.
• Establish systems and processes to ensure that QC procedures, systems, data and documentation follow cGMP, data integrity requirements, regulations and meet the needs of the Manufacturing and Supply processes.
• Ensure that QC Team is aligned to the requirements of the MPD process for specific projects by either acting as Analytical Workstream Lead, Analytical Workstream SME or by supporting the MPD workstream leads / members.
• Deliver GMP compliant QC data/reports through management of an internal QC team or 3rd Parties for the support of batch release and stability for critical reagents, reference materials, raw materials, cell banks, starting materials, drug substance and drug product.
• Ensure change controls, quality deviations, out of specification results and quality / business risks associated with area of responsibility are appropriately investigated, reviewed, mitigated and closed out.
• Author or review analytical data and commentary for regulatory submissions as required.
• Represent Quality Control during internal audits and regulatory inspections for area of responsibility.
• Bachelors or Masters degree in the Life Sciences field
• At least 3 years experience of Quality in a GMP environment
• Knowledge of Qualification and Validation of Analytical methods as well as Tech Transfer of Analytical Methods
• Demonstrable experience in designing and implementing local quality control systems and processes
• PhD in the Cell and Gene Therapy related area
• Experience of Quality Control for Cell and Gene Therapy or Biopharmaceutical products
• A strong understanding of and the ability to apply quality requirements, regulatory requirements and risk management to cell and gene therapy products appropriate to the stage of development.
• Working with third parties.
• Strong organizational and communication skills
• Demonstrable ability to lead multi-disciplinary, multi-cultural teams
• Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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