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:
1. 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.
2. Ensure team sets a strong example with regards to Quality and Compliance performance, as well as to drive prompt resolution of issues.
3. Promote safe working practices in the area and provide direction and oversight for the functional environmental, health and safety (EHS) programmes.
4. Promote quality and compliance within the stream and monitor all quality related systems, improvement procedures and documentation.
5. Ensure resource management processes are in place to deliver Batch Release, investigation and operations oversight and support to projects.
6. Support audits across the site (including overseeing L1 audit programmes within the team).
7. Be an effective member of the wider Value Stream management team (eg; provide input into strategy and objectives).
8. 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.
Basic Qualifications:
1. Qualified Person (QP) stated on a current UK Manufacturer’s/Importer’s licence
2. Knowledge of current Good Manufacturing Practice (cGMP) requirements.
3. Knowledge and application of the principle of the Quality Management Systems (QMS).
4. Experience of people-management (highly advantageous).
Closing Date for applications: Tuesday 8th of October 2024 (COB).
Benefits:
* 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)
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