New position for a Quality Assurance Specialist with experience in Tech Transfer and UpStream Processing within a large international pharmaceutical concern!
Introduction:
Our client, a leading player in the biotechnical and pharmaceutical industry, is undertaking Project Pollux, which involves establishing a new Lentiviral Vector (LVV) production facility in the Netherlands. This project will contribute to the global Janssen BCMA CAR-T program for multiple myeloma, with the goal of benefiting around 160,000 patients annually. As part of this exciting initiative, we are looking to strengthen the Pollux Quality Department with a Senior QA Associate. This role will focus on providing QA oversight over Tech Transfer in UpStream processing, up to PPQ and routine production. The ideal candidate must have strong communication skills, a risk-based mindset, attention to detail, and an ability to lead effectively in a complex environment.
Job Description:
As a Senior QA Associate for Project Pollux, you will play a key role in ensuring compliance with all regulatory requirements, especially in relation to the pharmaceutical industry, health, safety, environmental legislation, and cGMP requirements. Your responsibilities will include setting GMP standards and guidelines for Tech Transfer, Process controls, and the introduction of materials and Single Use Systems. You will ensure that the manufacturing process and all its controls align with regulations and the license, approving related documentation such as Work instructions and eBatch Records. The use of Risk Management tools in your daily work and promoting their adoption throughout the project team will be essential. You will review and approve non-conformance investigations, ensuring timely implementation of corrective actions. Additionally, you will collaborate with external Quality contacts in the LVV/CAR-T supply chain and actively drive the introduction of emerging technological/digital solutions in Quality.
Responsibilities:
- Act as the primary Quality contact in the Pollux project, ensuring compliance with regulatory requirements and cGMP standards
- Set GMP standards and guidelines for Tech Transfer, Process controls, and the introduction of materials and Single Use Systems
- Ensure manufacturing processes and controls are aligned with regulations and license requirements, approving related documentation
- Utilize Risk Management tools and advocate for their use within the project team
- Review and approve non-conformance investigations, ensuring timely implementation of corrective actions
- Raise serious quality, compliance, and GMP incidents to Department or Project Management
- Drive the introduction of emerging technological/digital solutions in Quality
- Collaborate effectively with colleagues at the Site and globally, sharing Best Practices and exceeding Customer needs
Requirements:
- Proven experience in a Quality role in the biotechnical or pharmaceutical industry, with a minimum of 4-8 years in a GMP regulated environment
- Bachelor's or higher degree in Biochemistry, Biology, Pharmaceuticals, or related field
- Excellent understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines
- Strong problem-solving skills in a complex environment, balancing business needs, regulatory requirements, and cost efficiency for all Quality decisions
- Ability to drive teamwork in a fast-paced environment and connect easily at all levels in the organization
- Empowered professional who drives a Quality Mindset and can make well-motivated pragmatic decisions independently
- Preferred experience in Tech Transfer and Risk Assessments
- Working knowledge of Eudralex Annex 1 is an advantage
- Proficiency in English both in writing and speaking
- Limited travel required for the job, with occasional on-site work demands
Benefits:
- Contract; ~1 year through Oxford
- Salary; €3750 - €7500 based on a fulltime, 40 hour work week. Height of the salary depends on your experience and background
- Opportunity to work on a project that impacts the health of patients worldwide
- Chance to work with a dynamic and diverse team, driving Quality decisions and embracing innovation
- Holidays; 25
- Working hours; full-time, 32 hours possible; remote work is possible for this position (2-3 days varying with the amount of work that needs to be done)
Vacancy number; 23268
