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Senior Advisor Cell & Gene Therapy QA

Location:
Stevenage
Company:
GlaxoSmithKline

Description

Job description

Site Name: UK - Hertfordshire - Stevenage
Posted Date: Aug 24 2020

Senior Advisor Cell & Gene Therapy QA

Stevenage

This is an exciting opportunity to be involved in a large cutting-edge programme due to be undertaken by GSK. To thrive in this challenging role, you must be determined and ambitious to succeed. You will have the chance to work with innovative technologies and be part of a high visibility project at GSK.

Key Responsibilities:

  • Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D. Specifically, with respect to the Catapult Cell Product Area, define the processes and procedures to operationally oversee the manufacture and release of Cell and Gene Drug Product.
  • Assure products meet regulatory requirements and that they conform to regulatory submissions. Specifically, for Catapult Cell Production Area, establish the minimum requirements and expectations for how such a facility will be presented to regulators.
  • May interact with regulators during tours of the Catapult Cell Production area during licensure and on inspection.
  • May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues. Specifically, for the Catapult Cell Production Area, inspection readiness activities, ready for GMP, Pivotal Clinical, and potential for PAI may be led or supported by the incumbent.
  • May lead a project, program or team activities which may include GxP as part of the Catapult Cell Production Area start up and licensure.
  • May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports.
  • 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.
  • Provide 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 Product Quality Pharma R&D 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 GSK business needs.
  • Communicate and interact at various levels internally and externally to GSK.
  • Build and maintain effective internal GSK business relationships within business units.

Specific Accountabilities:

  • Promote a high level of GMP awareness and compliance in business Catapult partner areas and Catapult project teams.
  • Approve GMP documentation, including Standard Operating Procedures validation documentation, change controls and other controlled documents from Catapult and business partner areas.
  • Write Standard Operating Procedures pertaining to Quality Assurance and Catapult / business partner GMP systems.
  • Perform internal assessments to measure compliance with appropriate GSK policies and procedures.
  • 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.

Essential criteria:

  • Degree qualified in science based subject or equivalent experience
  • Experience in Cell and gene therapy or Cell Biology

Preferred:

  • Qualified person (QP)
  • Quality experience

CLOSING DATE for applications: Thursday 6th August 2020

When applying for this role please draw attention to your relevant experience in fermentations science and scale-up experience in your CV. The information that you provide will be used to assess your application. Please save a copy of the job description as this will not be available after the closing date.

About GSK:

GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com

Why GSK?

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.

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 ukdiversity.recruitment@gsk.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.

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