Assoicate Direcitor, Quality Management & Training, Clinical Operations

Shanghai, China   |   full time   |   Job ID: 9279 

Your main responsibilities are:  

Quality Management Area

• As part of the CO Quality team, be responsible for the quality initiatives, this will include but not limited to:

1. 1. Implement global and local quality initiatives within CO Participate, support and actively contribute to continuous process improvements, knowledge management and training management within CO, when applicable
   2. Work closely with QA team to identify areas for quality improvement and discuss suggestions; support CO to plan /strategize quality initiatives and ensure implementation
   3. Be able to develop local SOPs/Working Instructions for CO team as necessary in collaboration with QA.

• Inspection Readiness

1. 1. Work closely with CTMs within CO to ensure inspection readiness plan is implemented for the assigned trials
   2. Familiarize with assigned trials for inspection readiness and lead/coordinate inspection readiness activities for the assigned trials
   3. Collate progress / status report of inspection readiness preparation activities for assigned trials and communicate such status / progress to stakeholders
   4. Support CTMs to ensure gaps identified during inspection readiness are appropriately addressed
   5. Collaborate with QA colleague to perform trend / GAP analysis for the trials that undergo inspection readiness, if required; and work with trial team to develop preventative measurements; to ensure preventative measurements are implemented

• Work with QA and other stakeholders to support CTMs and CRAs during a site inspection or sponsor inspection; furthermore, coordinate certain activities on behalf of clinical operations, if required and appropriate.
• Take the role of audit response coordinator within CO to ensure all the audit observations are addressed properly within timeline.
• Take the lead of associated vendors’ qualifications and management within CO.

Training Area

• Design, lead and oversight training program at all levels of the Clinical Ops based on local business team needs
• Work with CRA Line-manager to coordinate the internal CRA trainings and drive the quality mindset culture in Clinical Operations department
• Liaise with global training team to develop and drive the local training process and delivery
• Conduct local needs assessments to identify skill gaps and develop targeted training solutions.
• Collaborate with CO head and other stakeholders to ensure training materials are accurate and up-to-date.
• Evaluate the effectiveness of training programs and make recommendations for improvements.
• Monitor and track employee progress and provide ongoing coaching and support.
• Stay up-to-date on industry trends and best practices in training and development.
• Oversee the implementation of new technologies and tools to enhance training delivery.
• Collaborate with other departments to identify training needs and develop cross-functional training programs.
• Ensure compliance with company policies and procedures in all training activities.
• Partner with HR to ensure training programs align with performance management and career development initiatives.

What you have to offer

• Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences.
• Minimum 8 years' experience in clinical operations.
• QC and Training related experience or equivalence will be a plus
• Excellent understanding of ICH GCP,  and other applicable regulations, policies related to clinical trials
• Good communication and organization skills
• Fluent in reading, writing and speaking English
• Experience With Learning Management Systems And E-Learning Platforms.

Your Benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.