Our client – Northway Biotech – a group of companies in the biopharmaceutical sector, developing innovative and biosimilar biologic products for clinical use and large-scale production. Company aims to be the leader in development & production of biopharmaceuticals for a better life for patients. As CDMO (Contract Development and Manufacturing Organization), company supports the global pharmaceuticals market with the capability to develop biopharmaceuticals from the gene to the manufacturing of the final drug product.
We are looking for a motivated Quality Assurance Specialist to join modern BIO CITY facilities in Vilnius, a leading gene therapy center in the Baltic States, dedicated to development and manufacturing of gene therapies.
We are welcoming a colleague to join Quality assurance team as group manager, to lead QA group and take full accountability for all quality-related activities, with a primary focus on ensuring timely and compliant batch disposition. The successful candidate will oversee the QA team, drive compliance with GMP and regulatory requirements, and ensure that product release decisions meet the highest standards of quality and safety.
Job description
- Perform quality assurance activities to ensure compliance with GMP regulations and internal quality standards.
- Review and approve batch records, SOPs, protocols, and other quality documents.
- Take leadership in investigations of deviations, OOSes, and implementation of CAPAs (Corrective and Preventive Actions).
- Support quality review and release of finished products.
- Collaborate cross-functionally with Manufacturing, QC, and Regulatory teams to resolve quality issues.
- Assist in training personnel on GMP requirements and quality processes.
- Participate in continuous improvement projects aimed at enhancing product quality and operational efficiency.
- Maintain up-to-date knowledge of GMP regulations, industry best practices, and emerging quality standards.
Expectations for the new colleague
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Chemistry or related field.
- Excellent attention to detail, analytical skills, and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work independently and collaboratively in a dynamic environment.
- Proficiency in English.
- Experience in Quality Assurance within a GMP biologics manufacturing environment, preferably in a CMO setting would be an advantage.
- Familiarity with regulatory submissions and inspections would be an advantage.
Company offers
- Competitive salary. Salary range for this position: 2300 EUR to 2800 EUR gross (before taxes). The final offer depends on competence, qualifications and experience.
- Exposure to a cutting-edge biologics manufacturing environment.
- Opportunities for professional growth, career development in a state-of-the-art biotechnology setting.
- Innovative, hard-working and quality-driven, collaborative, supportive company culture.
