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Senior Director of Quality Incident Management
1 month ago
Complaint and Incident Senior Director
The Complaint and Incident Senior Director is a critical role within Market Supply & Distribution Quality (MSDQ) that will be accountable for the GSK network quality incident management, including complaints, LIC (Local Incident Committee), Product Incident Review Committee (PIRC) and recalls.
Key Responsibilities- Accountable for inspiring and motivating teams and colleagues, priority planning, with risk-balanced decision-making skills.
- Responsible for bringing to life the One Quality voice to simplify and standardize our ways of working internally and externally.
- Accountable for a diverse team coordination and reviewing complaints and incidents for the GSK network, ensuring robust investigation and clear CAPA.
- Working closely with legal teams, LOC teams and GRA to optimize response to complainants and authorities.
- Provide leadership and management of the centralized team, and key site/ EQ/ LOC incident managers to ensure capability and timely RFT investigations.
- Responsible for ensuring PIRC chair/ secretary support to the business units.
- Engage with key stakeholders across operational business units and MSDQ to prioritize support.
- Motivate, focus, and develop your team, inclusive and ambitious leader that facilitates a thriving team, with clear succession plans for key roles.
- Strategic mindset balancing short-term and long-term objectives, translating vision into breakthrough objectives.
- Responsible for influencing direct and extended GSC Quality team to support the adoption and usage of new ways of working and develop a culture of continuous improvement.
- Functional business owner for product recall system PRS and complaints module in VQMS, will support operational business units and feed information as required to MSDQ Process team and QA Systems team.
- BA/BS degree or equivalent in experience. Area of Specialisation: Chemistry, pharmacy, biological sciences, science related.
- BA/BS or Masters Degree.
- Minimum of 10 years' experience in Quality function in a highly regulated environment.
- Experience leading a team with a strong background managing complaints/incidents within Quality.
- The role holder must have significant knowledge of the pharmaceutical industry, knowledge of the products and respective incident and complaint classifications this team will manage.
- Problem solving and decision making ability is key to being effective in role.
- Significant experience in drug product manufacture and distribution.
- Experience in QP and batch release would be desirable.
- Proven capacity to drive transformation and manage complex projects and program of projects. Strong in decision-making, problem-solving, and communication.
- Excellent influencing and negotiating skills and verbal and written communications skills.
- Demonstrated ability to operate effectively in a matrix organisation and engage with other business areas.
- Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues.
- Demonstrated leadership of people, including development and performance management skills.
- Cultural agility.
- Knowledge and experience in operational excellence / continuous improvement techniques and deployment.
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.
