Quality Specialist Compliance

Job Description

As Quality Specialist Compliance you support the deployment or management of Kite Pharma Site Compliance as part of the department Quality Systems and Compliance. The position interfaces, as compliance partner, with many departments and internal and cross site stakeholders.

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 Quality Specialist Compliance you will be joining the Quality Systems & Compliance team in which people of all backgrounds and experiences are respected. The sub team Quality Systems Compliance is responsible for the systems and activities listed below of which ownership is divided among the team. You will be reporting to the Director Quality Systems and Compliance.

Responsibilities (include but are not limited to):

• Support at site level or as a member of cross site Compliance committees, conformance to regulations and quality policies

• Support site internal audit program and conducts internal audits ensuring compliance of site processes and systems to, EU and ROW regulatory requirements

• Manage/ Monitor all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA,

• Participate in the development, implementation and maintenance of procedures and templates to assist in the execution of the site audit program

• Assist in development of effective auditing tools and training aids

• Participate in Site Inspection Readiness and inspection management programs

• Support regulatory inspections and audits

• Ensure proper maintenance and approval of cGMP documents,

• Identify compliance risks and escalate issues to appropriate levels of management for resolution

• Provide compliance guidance to technical transfer activities, as required

• Support tracking and reporting metrics and management information for use in continuous improvement and Quality Management Review

• Support the Compliance system, (AGILE) and deliver training (including administration)

• Support generation of annual quality reports

Additional job duties as required.

Requirements:

• Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar) with 5+ years of relevant experience in the pharmaceutical industry

• Strong understanding of a GMP working environment

• Strong knowledge of GMPs, ATMP (pre), Pharmaceutical Law and legislation   

• Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience is a pre

• Ability to troubleshoot and resolve technical issues

• Proficient with computers and word processing software (i.e. Microsoft Office products)

• Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment

• Ability to work effectively in a team environment

• Ability to works under light supervision utilizing good time management skills

• Quality mindset

Working location is Hoofddorp.