Sr Quality Assurance Specialist ATMPs at NECSTGEN
Are you a Senior QA Specialist ready to play a key role in realizing a state-of-the-art GMP facility and support the development of cell and gene therapies? Be among the first to join our expanding team to support the establishment of a sound QMS and reach GMP certification by early 2022.
What we ask
We are looking for a Sr. Quality Assurance specialist, preferably with an educational background in Life Science or related and:
- Over 5 years of experience in GMP;
- Experience within a sterile manufacturing environment (biologicals, vaccines, injectables, parenterals or ATMPs) this is a must;
- Experience with writing and reviewing GMP documentation;
- Experience with risk assessments, CAPAs, Change controls and deviations;
- Experience with electronic quality systems like Trackwise, EtQ, Doc Space, Doc Share, Agile or related is a plus;
- Understanding of the dynamics, opportunities and demands of a scale-up environment;
- Ability to work in a multi-cultural environment;
- Good communication, negotiation and persuasion skills when dealing with complex situations.
At NECSTGEN we look beyond today’s possibilities and together with our clients and partners aim to get more novel cell and gene therapies into the clinic and to the patient. NECSTGEN spun out of the Leiden University Medical Center (LUMC) by recognizing the needs of specifically early-stage research organizations and start-ups to efficiently develop cell and gene therapies. NECSTGEN is not a regular CDMO but a centre of expertise with a unique position enabling us to dedicate our resources to delivering high quality services accessible for early stage research organizations. We support the translation of novel therapies and technologies to GMP operations and clinical trials. NECSTGEN offers development and GMP manufacturing services, including fill and finish and brings together expertise from R&D, process development including analytical, Quality Assurance, Quality Control, Regulatory Affairs, Business development and manufacturing in a purpose-built non-profit GMP production facility.
Our current team consists of professionals from industry and academia with an entrepreneurial mind-set and a drive to make a difference. We are a flat organization with a participative management style. Visit our LinkedIn company page to learn more about our team and the latest developments.
As Sr. QA specialist at NECSTGEN you will enjoy the best of both worlds; excellent fringe benefits, a competitive salary and the opportunities and dynamics of a scale-up environment. A standard fulltime position at NECSTGEN is 36 hours, a part-time position is negotiable. In addition to your salary you receive a 13th-month payment and 8% holiday allowance.
Because as Sr. QA specialist ATMP you will join the team at a very early stage you get the unique opportunity to co-define the company and contribute to the establishment of NECSTGEN. All people joining the team now contribute expertise critical for the successful launch of NECSTGEN and hence you will enjoy a lot of responsibility and impact on key decisions.
What you will do
NECSTGEN will provide cell and gene therapies expert knowledge for the development and clinical manufacturing to a variety of customers at various stages of the therapy life cycle. Since NECSTGEN is a scale-up we are looking for a specialist with flexibility and a hands-on mentality. As Sr. Specialist QA you will report to the Head of QA. Within NECSTGEN you will act as the QA Subject Matter Expert for ATMP production processes. Part of NECSTGEN core mission is to facilitate our clients transition from R&D to GMP. This implies that you as QA specialist will play a key role in steering our clients towards GMP compliant processes. In short, you as Sr. QA specialist will:
- Collaborate directly with the Head of QA supporting the deployment of the eQMS and GMP certification process;
- Support future client projects, integrating internal teams working closely together with development, manufacturing and QC and act as QA liaison with external partners;
- Coordinate and collaborate with consultants;
- Support the recruitment and training of future QA staff;
- Reviewing of GMP documentation like SOPs, qualification/validation documentation, batch records, etc….
- Maintain the quality system and report quality KPIs (Key Performance Indicators);
- Participate in audits.