QC Team Lead

Job Description

As the Team Lead for QC sample management you will be responsible for line management, supervision and coordination of a group of QC technician (6-10 FTE) whose primary goal is to ensure the management of samples within QC.  

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast-moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As the Team Lead for QC Sample management you will be joining a team in which people of all backgrounds and experiences are respected, and where working together while being focused on saving lives by finding the cure for cancer is a daily activity.

The QC Sample management group is part of the Quality Control department. The Quality Control department ensures consistent quality throughout the manufacturing process by providing accurate testing of Incoming Goods, in-process samples, final product, environmental monitoring, and stability samples.  The team is diverse, enthusiastic and hard-working.

You will be reporting to the Manager of QC Service.

Your Responsibilities

In this role, you will lead a group of QC technicians, whose primary goal is to support the QC department while ensuring total cGMP compliance. The team lead will manage all resources (Technician, training, deviations, changes, Lab area, Sample related project, documentation etc.) to ensure timely delivery of high-quality support and reporting.

You will be involved in improvement projects of the lab and designing the processes to make the QC laboratory efficient and compliant. Building a team of qualified individuals and a high team spirit will be one of your core responsibilities. Due to the nature of the product and speed of treatment, this role requires a high level of proficiency and ownership of the process.

Your responsibilities, among others, will be:

• Lead one of the QC sample management groups (approx. 6-10 FTE)
• Act as an advisor and technical resource to your team.
• Coordinate and perform training of new personnel and manage training records for the group.
• Coordinate and work with the team to troubleshoot issues and provide solutions.
• Organize and prioritize daily tasks to ensure an efficient process and timely review and release.
• Monitor the GMP systems currently in place to ensure compliance with documented policies and safety regulations
• Lead investigations and supporting continuous improvement initiatives
• Write, review and/or implement deviations, change controls and CAPAs
• Write, review and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.)
• Act as a SME during audits and Regulatory Inspections
• Interact with other departments and within QC in a professional manner and join in applicable meetings
• Support other groups within QC to reach the departmental goals
• Perform other duties as required by QC management

Challenges of the Role

• Working in a fast-paced environment: coordination of a large number of items with tight timelines
• Maintain compliance and safe working environment despite time pressure
• Take part in developing the QC department, documentation, processes and culture

Your Profile

The ideal candidate has a can-do attitude and thrives in a fast-paced environment. Because the QC group is involved daily with multiple departments, a strong ability to communicate and coordinate is essential to ensure a smooth and efficient process.  The ideal candidate should possess a technical mind but is also able to think outside the box in order to use logic and sound judgment to provide solutions to problems.

Education

• A BSc degree and 4-6 years of experience in the Biotech and/or Pharmaceutical Industry

Knowledge/Experience

Required:

• Full working knowledge of GMPs, pharmacopoeia and regulatory requirements
• Proficient in the application of QC principles, concepts, industry best practices and standards
• Management, organization and prioritization skills
• Strong interpersonal skills and willingness for teamwork
• Previous hands-on experience in QC systems (Like QC instruments including software and LIMS)
• Project management skills
• Experience at performing and concluding investigations
• Experience in writing and implementing deviations, change controls and CAPAs
• Experience in writing or updating SOPs, reports and risk assessments
• Strong verbal and technical writing skills (English)
• Experience with participating in audits (regulatory, customers, inter-organizational)
• Willingness and ability to join corporate meetings in the (early) evening, when required.

Personal skills

Required:

• Comfortable in a fast-paced environment with minimal direction
• Ability to adjust workload based upon changing priorities
• Flexible, strong organization skills and a strong team player
• Excellent English communication skills

Application Process:

As part of our recruitment process, you will be asked to complete a short 20-minute online Occupational Personality Questionnaire (OPQ) and/or a capability test.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.

Apply now!