Training and Quality Manager

THE POSITION:

The Training and Quality Manager is responsible for developing and implementing comprehensive training programs to enhance employee skills and knowledge, as well as ensuring adherence to quality standards across all departments. This role involves designing training modules, evaluating training effectiveness, and continuously improving training methodologies. Additionally, the Training and Quality Manager oversees quality assurance processes, conducts audits, and provides actionable feedback to improve performance and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

 Develop and implement training programs for new hires and ongoing skill development for existing employees.

 Design training modules, materials, and resources tailored to specific job roles and departmental needs.

 Conduct training sessions through. various methods such as classroom instruction, workshops, online modules, and on-the-job training.

 Evaluate training effectiveness through assessments, feedback mechanisms, and performance metrics.

 Continuously update and improve training content and methodologies based on feedback, industry best practices, and organizational needs.

 Collaborate with department managers and subject matter experts to identify training needs and address skill gaps.

 Monitor and ensure compliance with quality standards, regulations, and company policies.

 Develop and implement quality assurance processes, including audits, inspections, and performance evaluations.

 Analyze quality data to identify trends, root causes of issues, and areas for improvement.

 Provide constructive feedback and coaching to employees to enhance performance and adherence to quality standards.

 Develop and maintain documentation related to training materials, procedures, and quality assurance processes.

 Serve as a liaison between departments to promote cross-functional collaboration and alignment on training and quality initiatives.

 Keep abreast of industry trends, regulatory changes, and advancements in training and quality management practices.

 Collaborate with senior management to develop strategic goals and initiatives related to training and quality improvement.

 All other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

An individual in this position must be able to successfully perform the expectations listed above.

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

 Minimum of 10 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.

 Demonstrated experience in training and quality management roles, preferably within pharmacovigilance or regulatory affairs.

 Proven track record of developing and implementing training programs and quality assurance processes in a pharmacovigilance setting.

 Experience with pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements.

 Familiarity with safety databases (e.g., ARGUS, ARISg, or similar) and adverse event reporting systems.

 Strong understanding of pharmacovigilance principles, drug safety surveillance, and risk management processes.

 Experience conducting audits, inspections, or assessments related to pharmacovigilance activities.

 Knowledge of quality management systems (QMS) and continuous improvement methodologies such as Six Sigma or Lean.

 Experience with metrics and key performance indicators (KPIs) related to pharmacovigilance quality and compliance.

 Previous experience in leading cross-functional teams and collaborating with stakeholders across different departments.

 Experience in handling regulatory inspections and audits from health authorities (e.g., FDA, EMA).

 Experience in developing and delivering pharmacovigilance training to diverse audiences, including medical professionals, researchers, and regulatory personnel.

 Familiarity with risk management plans (RMPs), periodic safety update reports (PSURs), and other pharmacovigilance documents.

 Strong analytical and problem-solving skills, with the ability to identify root causes of issues and implement corrective actions.

 Excellent communication, presentation, and interpersonal skills, with the ability to effectively interact with individuals at all levels of the organization.

 Certification in pharmacovigilance from a training institute or university is desirable.

PREFERRED QUALIFICATIONS:

 Masters degree in Pharmacy, Life Science, Nursing, or a related field.

 Proven experience in training and development, quality assurance, or a related role.

 Strong understanding of adult learning principles and instructional design methodologies.

 Excellent communication, presentation, and facilitation skills.

 Ability to develop engaging and interactive training materials.

 Analytical mindset with the ability to interpret data and identify trends.

 Experience with quality management systems and tools.

 Familiarity with regulatory requirements and compliance standards relevant to the industry.

 Strong organizational skills with the ability to manage multiple projects simultaneously.

 Leadership abilities with a focus on coaching, mentoring, and team development.

 Proficiency in Microsoft Office Suite and learning management systems (LMS).

 Certification in training, quality management, or related field is a plus,