Quality Assurance Manager

This is a fully remote position, open to applicants in Lithuania.

📋 Description

• Create, assess, and oversee the standard operating procedures (SOPs) for company processes, ensuring adherence to local and international standards and regulations.

• Guarantee the ongoing effectiveness and enhancement of the quality management system, ensuring that clinical trials, pharmacovigilance, regulatory affairs, and good clinical practice training services comply with relevant regulations, good clinical practices (GVP), good clinical practice (GCP), ISO 9001, ISO 13485, and ISO 27001 standards.

• Execute GxP audits in line with agreements with clients and/or internal audit programs.

• Oversee vendors’ quality evaluations and audits.

• Manage activities during second and third-party audits or regulatory GCP and GVP inspections within the company, and administer corrective and preventive action plans post-audit.

• Complete and maintain quality management system documentation and necessary accountability forms.

• Identify non-compliances, present and discuss findings from audits, supervise the implementation and effectiveness of corrective and preventive action plans, and offer recommendations for enhancements.

• Assist in conducting root-cause analyses and other problem-solving initiatives to determine effective corrective actions and process improvements in collaboration with personnel.

• Engage in the training of staff by preparing and delivering training on relevant quality and legal requirements.

• Implement and track processes that ensure quality standards are met.

• Provide support for all quality management initiatives.

⛳️ Requirements

• A higher education degree in Life Sciences (such as Pharmacy, Medicine, Biology, Biotechnology, or a related field).

• Required knowledge of EU Good Pharmacovigilance Practices (GVP); familiarity with Good Clinical Practice (GCP) is a plus.

• A minimum of 5 years' experience in a pharmacovigilance and/or clinical research setting, including quality assurance experience pertaining to GVP and/or GCP activities.

• Knowledge of additional GxP requirements and familiarity with ISO 9001, ISO 27001, and ISO 13485 standards would be advantageous.

• Proficient computer skills and experience with eLMS and eQMS programs.

• Capability to develop quality management systems and procedures.

• Professional proficiency in English, both spoken and written.

• Strong critical thinking and problem-solving abilities.

• Exceptional presentation, written, and verbal communication skills.

🏝️ Benefits

• Opportunities for professional growth and career advancement.

• Work within an international team and environment.

• Performance-based bonuses annually.

• Personal accident and business trip insurance.

• Additional health insurance coverage.

• Access to influenza vaccinations.

• Attractive referral policy rewards.

• Team-building activities, global meetings, and B active events.