Small Molecule R&d Quality Director
Il y a 4 mois
**Site Name**: UK - London, Belgium-Wavre, Singapore - Tuas, UK - United Kingdom, USA - Pennsylvania - Upper Providence, Ware
**Posted Date**: Aug 30 2024
**Job purpose**:
As the Small Molecule R&D Quality Director, you perform the quality assurance activities and quality oversight of the GMP functions performed within Small Molecule R&D, essentially related to the manufacturing of clinical material.
**Your responsibilities**:
As the Small Molecule R&D Quality Director, you
- Develop and implement strategy, policy and group objectives that build competency in operational excellence in quality assurance of clinical products.
- Are accountable for building continuous improvement into the processes and ways of working to optimize end to end quality and right first time.
- Interact with regulators and/or industry experts to represent GSK interests.
- Are responsible for leading the team in a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance based culture.
- Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.
- Are responsible for analysis, assessment, management, and communication of inherent and emerging risks to GSK management.
- Are responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.
- Are accountable for team of global Quality Assurance managers, will motivate, focus and develop the team in an inclusive environment to build a high performing team.
- Are responsible for representing Quality R&D, providing relevant information to governance boards and one voice of GSK internally and externally.
- Are responsible for the timely release of material for clinical studies, compliance with the third party assessment schedule.
- Ensure a robust GxP training program, that appropriate qualification, validation and change control activities are undertaken within business partner areas.
- Are responsible for quality oversight, ensuring robust quality management systems are in place.
**Additional information**:
- Reporting line: Head of R&D GMP Quality Director
- Number of positions available: 1
- People management (direct/indirect reports, etc.): approx. 10 direct reports
- Business travel requirements: 10%
- Primary location: Ware, UK
- Secondary locations: Upper Providence (US), Wavre (BE) or Singapore - Applicants should be based in or close to these locations with a valid local visa/work permit.
**_ Why You?_**
**Basic Qualifications**:
- We are looking for professionals with these required skills to achieve our goals:_
- Minimum BA/BS degree in Science or Engineering or equivalent in experience
- Minimum 10 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA)
- Minimum 5 years of experience in a quality management roles in manufacturing or analytical testing and release
- Demonstrate knowledge of technical and operational domains within an R&D changing environment e.g. bacterial, viral bulks immune-stimulants, mRNA, formulation, filling, freeze-drying
- Ability to lead, influence and negotiate at all levels within the organization
- Ability to ensure a consistent approach in the interpretation and implementation of GMP/GDP standards
- Problem solving and negotiation skills
- Ability to evaluate risk
- Ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest
- Fluency in English both written and spoken
**Preferred Qualifications**:
- If you have the following characteristics, it would be a plus:_
- Master's or PhD in Science or Engineering
- Interpersonal skills with demonstrated ability to engage, empower and influence people
- Understanding of cGMP and regulations applicable to GSK in the relevant countries (FDA/EU/WHO and other countries)
- Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolution
- Ability to drive change and continuous improvement
- Ability to work transversally in matrix organization, with global perspectives
- Ability to make independent decisions even under pressure and navigate in grey zones
- Ability to communicate complex information both orally and in writing
- Ability to adapt, work under uncertainty and accommodate flexible work demands.
**Application closing date**:Sunday 15 September, 2024 EOB
- Please take a copy of the Job Description, as this will not be available post closure of the advert._
LI-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
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