(Associate) Manager, Quality, Capability and Risk Management

Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Dec 4 2022 Job Purpose The (Associate) Manager of Quality, Capability and Risk Management (aQCRM) is responsible for learning and capacity development in clinical operations in China, the management and implementation of internal control framework (ICF) elements, and the communication of high-quality standards in clinical research delivery. The (Associate) Manager, Quality, Capability and Risk management (aQCRM) may take on additional responsibilities or other roles such as global/local assignments as designated by Line Manager. Key Responsibilities Risk Management Support risk management activities Maintenance a local Risk Register and ensure appropriate mitigation of risks Management Monitoring Maintain an annual MM plan and ensure timely completion of activities by assigned local Clinical Operations team members, including MM CAPA ownership and completion Manage MM outputs, review outputs, and identify trends Issue Management Support adequate issue management, resolution, and escalation, as appropriate Involved in SQI identification and resolution, in collaboration with CQA, support SQI management and resolution. Audits/Inspections Support site inspection readiness activities and audits In collaboration with CQA/QM, support regulatory inspections Written Standards Support questions related to GSK written standards and processes Administrator for local Clinical Operations written standards Capabilities and Training In collaboration with the Global team and local Clinical Operations LT team, ensure that local staff are appropriately trained Manage local curriculum in MyLearning. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: At least 4 years of experience in the pharmaceutical industry, preferably in Clinical Operations, Clinical Quality Management or Clinical Quality Assurance. Good knowledge of international guidelines ICH-GCP as well as relevant local regulations. Good understanding of the drug development process and related GXP activities. Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP, study management, site management, monitoring. Good interpersonal, verbal, and written communication skills Good Presentation and facilitation skills Competent in written and oral English. Flexibility towards work assignments and new learning Able to take initiative and work independently Integrity and high ethical standard. Good ability to learn and to adapt to work with IT systems. Ability to travel nationally and internationally as required. Preferred Qualifications: If you have the following characteristics, it would be a plus: Solid understanding of the R&D and drug development process such that the employee is able to recommend and implement improvements to the process. Understands the study, project, and program level. Good interpersonal, communication and negotiation skills for use with a wide variety of audiences. Demonstrated management competencies in decision-making, accountability, study management, communication, problem solving, teamwork, negotiation, integrity, developing others and mentoring. Ability to work in a flexible manner and handle multiple tasks Flexible with high learning agility. Builds strong internal and external relationships. Create and/or support new ways of working. Has extensive knowledge of local regulations, IND/ICH GCP guidelines, GSK written standards. Ability to interact widely and effectively within the company at all levels. Ability to work in an environment of remote collaborators. Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Good analytical, problem solving, negotiation and conflict resolution skills. Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global and regional environment. Good cultural awareness. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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 impact the health of 2.5 billion people around the world in the next 10 years. 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. 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. 致候选人的重要提示： GSK招聘团队只会使用 @gsk.com 后缀的邮箱与您联系。若您收到任何声称来自GSK邀请您面试或请您提供任何个人信息的邮件，我们建议您留意发件人的邮箱地址，并谨慎回复。若您不确定您所收到的邮件是否来自GSK，请您通过[email protected]联系我们。