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 Head of Quality Assurance to join modern BIO CITY facilities in Vilnius, a leading gene therapy centre in the Baltic States, dedicated to development and manufacturing of gene therapies.
We are welcoming a colleague to join our Quality assurance team as group manager, to lead our 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
- Lead, mentor, and manage the QA team to ensure efficient and compliant quality assurance operations across the site.
- Take ultimate responsibility for batch disposition, including review and approval of batch records, deviations, investigations, and CAPAs to ensure timely product release.
- Ensure all QA activities comply with GMP regulations, internal SOPs, and regulatory guidelines (FDA, EMA, ICH).
- Develop, implement, and maintain robust quality systems and processes supporting manufacturing and product release.
- Oversee management of deviations, investigations, change controls, and CAPAs to drive root cause resolution and continuous improvement.
- Collaborate with Manufacturing, QC, Regulatory Affairs, and other departments to maintain seamless quality compliance throughout the product lifecycle.
- Provide strategic input and leadership on quality matters to senior management and stakeholders.
- Drive a culture of quality, accountability, and proactive risk management throughout the organization.
Expectations for the new colleague
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related discipline; advanced degree preferred.
- Quality Assurance experience in GMP biologics manufacturing, preferably within a CDMO environment.
- Proven leadership experience managing QA teams responsible for batch disposition and quality systems.
- In-depth knowledge of GMP regulations, FDA, EMA, ICH guidelines, and regulatory inspection requirements.
- Strong track record of managing complex quality systems including deviations, CAPAs, change control, and audits.
- Exceptional decision-making, communication, and interpersonal skills.
- Ability to lead cross-functional teams and influence at all levels of the organization.
- Experience managing audits and regulatory inspections with successful outcomes.
- Proficiency with electronic quality management systems (eQMS) and document control systems.
- Proficiency in English.
Company offers
- Competitive salary. Salary range for this position: 4500 EUR to 5500 EUR gross (before taxes). The final offer depends on competence, qualifications and experience.
- Leadership role in a fast-growing biologics CDMO.
- Opportunity to shape quality strategy and operational excellence.
- 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.
