Principal Device Engineer – Quality & Compliance

We are looking for an enthusiastic and experienced individual to lead and champion quality and compliance within Device Engineering (DE) in support of the development of new drug device combination products. Do you enjoy a challenging role with the opportunity to deliver robust products that improve the patient experience and can give them access to life changing medicines from the comfort of their own home? The role of Principal Device Engineer – Quality & Compliance will sit within Analytical & Operations and be part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices.

The candidate must be a motivated self-starter, with excellent verbal and written communication skills. They must have demonstrated ability to work independently and across organizational and geographic boundaries as well as working effectively in team and matrix environments. The candidate must have an understanding of Pharmaceutical Quality Management Systems and legislation that drives them and have experience of implementing and maintaining compliance to them.

The role is to be based at GSK’s R&D site in Ware, Hertfordshire (UK) and can offer flexible hybrid working.

In this role you will

• Be responsible for administering and maintaining staff training (MyLearning, MyGadget) and for developing and maintaining the Learning and Development infrastructure which includes competency frameworks and training plans required to support business needs. This will include assisting in the design and deployment of training materials and training packages and coordinating and supporting ongoing delivery of compliance training for DE
• Be expected to train as a business lead investigator (BLI), manage deviations within internal systems, propose CAPA’s from audits and perform effectiveness checks; coordinate relevant customer complaints; critically evaluate new processes with respect to quality and compliance requirements; lead GMP and non-GMP change controls that are owned by DE.
• Effectively communicate with managers, team members and Quality Leads on the performance of the team in relation to quality and compliance issues and standard ways of work using data and metrics to support this.
• Work closely with and become a conduit into quality groups e.g. validation, compliance, risk, Knowledge Management & Training, etc. Represent the department at applicable forums to ensure best practice is applied and harmonized
• Support the leadership team with the co-ordination of inspection readiness activities for both internal and external inspections and front audits for all QMS activities alongside the Analytical & Operations Manager (e.g. IBM, MHRA, etc)
• Communicate relevant quality alerts and lead any required changes and improvements associated with them
• Review laboratory quality documents and experiments, ensuring compliance to all relevant quality WoWs e.g. eLNB, LIRs, deviations, testing methods, validation documentation, trending reports, etc
• Support the testing team to occasionally perform simple testing/hand assembly of devices in the laboratory (full training will be provided).

Why you?

Qualifications & Skills:

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

• A graduate in the field of Science or Engineering with direct experience of leading quality compliance in an analytical or a quality-based function
• Demonstrated application of the principles of GMP and Quality Assurance
• Knowledge of analytical processes and procedures
• Experience of managing quality events (e.g. LIRs, CAPA, deviations, RCA, change control, etc)
• Experience of supporting internal and external audits
• Ability to closely monitor, engage and communicate quality compliance to leadership team

Preferred Qualifications & Skills:

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

• Experience of analytical processes and procedures
• Significant experience ensuring quality and compliance in a laboratory environment
• Excellent communication (written and verbal) and influencing skills
• Experience in developing strategies to ensure quality compliance and creating & embedding those new ways-of-working successfully
• Knowledge/experience of validation activities within a laboratory environment (i.e. equipment and method).
• Knowledge/experience in the management of laboratory safety systems (e.g. Risk Assessments, WERA, etc)

Closing Date for Applications: Monday 14th August 2023 (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.

#LI-GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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 neurodiversity, 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

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.