QC Team Leader, Open to flexible working

Stevenage, Hertfordshire
24 Feb 2021
08 Mar 2021
Contract Type

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.

We have an exciting opportunity for QC Team Leader to join our Platform Operations QC team.

Key Responsibilities include, but are not limited to:

  • Lead a team of quality control analysts to ensure the ongoing ability to perform GMP testing of cell and gene therapy materials.
  • Lead, Support and perform validation and routine analytical techniques used for the testing and release of cell and gene therapy products, including Cell based assays, flow cytometry, qPCR, ddPCR and ELISA.
  • Train on analytical methods, including associated equipment, software and systems and tech transfer into the CGT Central Testing Lab.
  • Set up capability for performing new analytical methods in CGTQC Central Testing Lab, including performing risk assessments, establishing and contributing to the validation of equipment and software and writing / reviewing documentation.
  • Author/review standard operating procedures and analytical instructions and Contribute to analytical tech transfer plans and qualification protocols for area of responsibility.
  • Ensure data integrity is maintained for all work performed within area of responsibility.
  • Act as Subject Matter expert and responsible for maintenance/compliance for Analytical methods, equipment's, system where designated as owner.
  • Lead, Support and perform validation and routine analytical techniques used for the testing and release of cell and gene therapy products, including Cell based assays, flow cytometry, qPCR, ddPCR and ELISA.
  • Ensure that QC Team is aligned to the requirements of specific projects by supporting QC Manager and MPD Analytical Workstreams as required.
  • Ensure change controls, quality deviations, out of specification results, and quality / business risks and actions associated with area of responsibility are appropriately manager and escalated.
  • Represent Quality Control during internal audits and regulatory inspections for area of responsibility.

Closing Date for Applications: 8th March 2021 (COB)

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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • BSc or Equivalent biological sciences.
  • Experience of Quality Control testing.
  • A strong understanding of and the ability to apply GMP principles to working in a Quality Control laboratory.
  • Biological assays experience/ELISA assays experience.
  • Designing and implementing local quality control systems and processes.
  • Qualification and Validation of Analytical methods.
  • Tech Transfer of Analytical Methods.
  • Strong organisational and communication skills.
  • Demonstrable ability to lead teams.
  • Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.

Preferred Qualifications:

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

  • Experience in Cell and Gene Therapy related area.
  • Ability to work with multidisciplinary teams to ensure execution of deliverable successfully.
  • Outstanding written, verbal and interpersonal communication skills.
  • Excellent project management skills.
  • Demonstrated problem solving abilities.
  • Ability to effectively communicate complex and technical information and influence stakeholders and technical staff.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

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.

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.