Senior Quality Advisor - Cell & Gene Therapy, Open to flexibility
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- Contract Type
Senior Quality Advisor - Cell & Gene Therapy, Open to flexibility
Since the structure of DNA was discovered by James Watson and Francis Crick in 1953, significant advances have been made in our understanding of diseases caused by faulty genes.
This has led scientists to ask, "If we can pinpoint a faulty gene and correct it, could we potentially find a way to treat the genetic diseases which are so devastating for patients and their families?"
Answering this question is something GSK scientists have been attempting to do in the rapidly developing field of cell and gene therapy - a groundbreaking approach to personalised medicine that involves repairing or replacing defective genes, cells or tissue using cutting edge techniques. Now we have an opportunity to join the exciting world of GSK CGT.
The opportunity is for a Senior Quality Advisor to join the team in Stevenage, UK.
- Develop and incorporate effective processes and procedures in GQC and may contribute to business processes and procedures outside GQC
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- May interact with regulators.
- May support/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
- May lead a project, program or team activities which may include GxP.
- May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports.
- Identifies 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.
- Provides advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK.
- May represent the group as a primary business contact for specific areas.
- Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to GQC and business units regionally and globally.
- Liaise with customers to provide compliance advice/input.
- Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
- Establish improvement processes, as needed, or set specific measurable targets and goals linked to GQC/GSK business needs.
- Communicates and interacts at most levels internally and externally to GSK.
- May influence and negotiate at most levels.
- Build and maintain effective internal GSK business relationships within GQC and business units.
Operational quality support for the release of CGT products manufactured on behalf of GSK by third parties to support clinical studies and commercial supply which includes:
- Building a relationship with the third party, in particular their quality department to facilitate the understanding of the third parties quality system and ways of working through regular/periodic meetings including visits to the facilities. Working with the third party to ensure that they meet GSK's expectations
- Initiation and maintenance of the Quality Assurance Agreement
- Single point of contact for the third party for resolution of issues and deviations including customer and vendor complaints
- Accountable for the release of batches supplied by the third party for GSK; including review of the third party batch records and analytical documentation.
- Work closely with internal partner groups to agree the release strategy
- Collecting the appropriate data to determining the supplier performance outcome
- Assist in the establishment of an C> QA strategy for GSK, and assist in the development and implementation of effective QA support model within GSK and at third party facilities.
- Ensure that activities regulated by Good Manufacturing Practice regulations undertaken by and/or for GSK at all contractor sites of operation throughout the world are compliant with relevant International Regulatory Agency regulations, and GlaxoSmithKline policies/procedures/standards.
- Analyse assessments of potentially significant GMP compliance risk information, and assure that GSK management is informed in a timely manner, and understands the business and regulatory risk associated with GMP compliance issues.
- Represent GQC both within and outside of GSK in a competent and professional manner.
- Assist in the management of GSK and regulatory agency inspections of third party manufacturers, where necessary, to assure successful outcomes are achieved.
Closing date for applications: Tuesday 24th April 2018
- Bachelors degree or above in relevant life science subject
- QA Experience in GxP environment including deviations and change control
- The ability to work independently and as part of a team
- Project management experience
- Managing 3rd party suppliers/collaborations
- Risk management
- Internal Audit experience
- Cell/gene therapy exposure
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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