Cell & Gene Therapy QRM Manager
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage
Posted Date: Oct 14 2020
The vision for the Cell & Gene Therapy Platform has been to develop an end-to-end organisation, integrating discovery, development and supply functions. This ensures that ground-breaking Cell and Gene Therapy medicines are seamlessly and expertly discovered developed and manufactured for clinical development and beyond. Organisationally the Cell & Gene Therapy Platform is composed of 5 functions: Synthetic Biochemistry, Discovery Research, Process Development, GMP Operations and Systems / Quality & Risk Management
A key activity for CGT QRM is to maintain the CGT Licence to Operate & Internal Control Framework certification in an increasingly complex environment of compliance and oversight.
This role is critical to integrate GSK and R&D quality, compliance and risk management policies and programs into the CGT business processes and ways of working, to ensure that the Internal Control Framework is integrated and compliant to corporate and regulatory standards
Intially the role will focus on document management and written standards by ensuring CGT is compliant on the right written standards, and that these are easy to understand and follow. There is an expecations that other compliance related initiatives can be incorporated into this role to enable a flexible workforce.
The CGT QRM manager will drive improvements across CGT quality and compliance performance (e.g. through reducing the number of deviations and CAPAs) by supporting authors in the composition of clear and effective written standards (e.g. SOPs, guidance).
Key responsibilities include;
- Single point of accountability, to facilitate maintenance and continuous improvement of CGT written standards and coordinate a robust stakeholder review process.
- Primary CGT contact to explore and develop a plan to enable CGT to transition to Optimum ways of working to ensure timeliness and quality of written standards.
- Partner with the CGT authors, to provide feedback on the written standard management process Manage and coordinate the review of written standards to ensure appropriate action is taken within the defined period. Review weekly plans and confirm CGT actions to be taken within the defined timeframe.
- Provide critical input into the design and continuous improvement of CGT written standards and associated training. Partner with CGT authors to create proposals for new and revised written standards. Ensure individual standards adhere to defined document quality standards.
- Ensure CGT processes are in alignment with industry regulations, GSK policies and the GSK Quality Management System. Partner with subject matter experts and Quality. Identify gaps and provide timely remediation.
- Compile metrics on CGT performance and report to senior leaders to help drive quality performance.
- Support authors of written standards in the completion of a learning needs assessment, development of effective learning materials and robust training delivery strategies.
- Help manage stakeholder review. Identify with authors the key stakeholders to review the written standard and support author with providing stakeholders effective notification outlining their responsibilities.
- Utilise iReview and stakeholder review meetings. Accountability for development and continuous improvement of CGT document management ways of working, systems and processes throughout the entire document lifecyle, including third party documentation processes and ways of working Acting as a delegate for the Head, systems and QRM when necessary
Closing Date for Applications:21st October 2020
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Required Qualifications and experience:
- Bachelor's degree/ or relevant experience
- Significant experience with the Pharmaceutical Industry, in drug development / CMC activities.
- Knowledge of the Internal Control Framework
- Experience of embedding new ways of working
- Experience of non-regulated, and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic.
- Ability to effectively communicate (written and verbal)
- Thrives in a faced paced environment with potential for significant change
- Ability to analyse trend and metrics data to drive continuous improvement
- Ability to effectively handle and appropriately escalate issues based on risk in a timely manner.
Additional preferred experiences:
- Experience working across multiple disciplines
- Understanding of GSK organizational structure including key contacts in R&D (Research, Development, Medicines Science and Technology), Pharmaceutical Supply Chain and Quality.
GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Back to top