Quality Operations Manager / Qualified Person (QP)

This job is with GSK, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Site Name: UK - Hertfordshire - Ware
Posted Date: Sep 17 2024

The Quality function promotes quality and compliance through the product life-cycle in the manufacturing and production operations across GSK Sites. The team supervises all quality related systems, improvement procedures and documentation (including analytical data and information) to ensure products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for the UK/EU markets).

Job Purpose:

As Quality Operations Manager you will manage a team of operational quality staff within the stream (promoting a culture of quality and improvement within Operations). The team will be up to 10 people (and may include interim/contract or third-party staff).

As a Qualified Person (QP) you will also review and certify finished products (batches) for release/onward progression (to market). QPs are responsible for ensuring that batches are manufactured in compliance with laws (for all the Member State where certification takes place) and in accordance with the requirements of marketing authorization (MA). All released products must conform to required quality standards (by reviewing appropriate documentation) and have been manufactured and packaged according to the regulatory dossier, Good Manufacturing Practice (GMP) and business requirements.

This role will be aligned to the OSD (Oral & Solid Dose) function.

Key Responsibilities:

• Provide coaching and mentoring for a small team of stream aligned quality personnel. Responsibilities include recruitment of direct reports, appraisals, 1:1s, training and development, performance management, talent management and reward and recognition.

• Ensure team sets a strong example with regards to Quality and Compliance performance, as well as to drive prompt resolution of issues.

• Promote safe working practices in the area and provide direction and oversight for the functional environmental, health and safety (EHS) programmes.

• Promote quality and compliance within the stream and monitor all quality related systems, improvement procedures and documentation.

• Ensure resource management processes are in place to deliver Batch Release, investigation and operations oversight and support to projects.

• Support audits across the site (including overseeing L1 audit programmes within the team).

• Be an effective member of the wider Value Stream management team (eg; provide input into strategy and objectives).

• Foster a continuous quality improvement culture within the OQ department and deputise for the Operational Quality Director as required.

Please Note: This role is a site-based role (Ware Manufacturing Site - Priory Street, Ware, Herts., SG12 0DJ).

About You:

You will be a Qualified Person (QP) - this is key to delivery in this role. Your QP qualification must be recognized in the UK.

As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills.

About Ware Manufacturing Site:

Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms.

The OSD value stream plays a unique role in the GSK network as the only designated facility for the launch of OSD products. The stream is currently in the process of moving into a new facility which will be fully operational in the coming months manufacturing commercial, clinical and development material. The role gives the successful candidate to develop their knowledge of technology transfer, collaboration with R+D organization as well as the chance to influence and shape the delivery of the future in the new building and the technologies being implemented.

CLOSING DATE for applications: Tuesday 8th of October 2024 (COB).

Basic Qualifications:

• Qualified Person (QP) stated on a current UK Manufacturer's/Importer's licence

• Knowledge of current Good Manufacturing Practice (cGMP) requirements.

• Knowledge and application of the principle of the Quality Management Systems (QMS).

• Experience of people-management (highly advantageous).

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

• Competitive base Salary

• Annual bonus based on company performance

• Opportunities to partake in on the job training courses

• Opportunities to attend and partake in industry conferences

• Opportunities for support for professional development/chartership

• Access to healthcare and wellbeing programmes

• Employee recognition programmes

• Hybrid (onsite/remote) working within GSK policies (post training period)

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

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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Location: Ware, GB

Posted Date: 9/19/2024