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 motivated Quality Compliance Specialist to join modern BIO CITY facilities in Vilnius, a leading gene therapy centre in the Baltic States, dedicated to contract development and manufacturing of gene therapies.
We are welcoming a colleague to join Quality compliance team and strengthen Quality compliance program. This role will primarily focus on managing audits, training programs, and raw material compliance, while also supporting overall QA activities to ensure strict GMP adherence and continuous improvement.
Job description
- Plan, coordinate, and conduct internal audits and support external audits (regulatory and customer).
- Manage and maintain the training program for all personnel to ensure GMP compliance and competency.
- Oversee raw material management, including qualification, approval, and periodic review of suppliers.
- Assist in reviewing and approving quality documentation.
- Investigate deviations, non-conformances, and facilitate CAPA processes.
- Collaborate with cross-functional teams (Manufacturing, QC, Regulatory) to resolve quality and compliance issues.
- Monitor compliance trends and recommend continuous improvement initiatives.
- Ensure compliance with GMP regulations, company policies, and industry best practices.
- Maintain accurate documentation and support regulatory inspections.
Expectations for the new colleague
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or related field.
- Excellent organizational, communication, and interpersonal skills.
- Detail-oriented with strong analytical and problem-solving capabilities.
- Ability to work independently and as part of a collaborative team.
- Proficiency in English.
- Knowledge of supplier qualification and vendor audit processes would be an advantage.
- Knowledge of GMP regulations (FDA, EMA, ICH) and quality compliance practices would be an advantage.
- Experience in audit planning and execution, training management, and raw material control 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.
