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**We see human behind every number**
**Associate Director, Quality Assurance**
**Location: Germany, UK or Poland (office-based/hybrid)**
At this position you will be responsible for organization of KCR strategies in the scope of Quality Assurance and providing direct compliance and support to all areas of operations of KCR within CEE region. You will ensure that quality standards of clinical research are abided by all KCR employees, contractors and subcontractors at each level.
**Detailed Job Duties and Responsibilities**
- Establishing of KCR strategy, standards and metrics for internal audits
- Preparation and approvals of internal audit plans
- Supervision and conduct of internal and external audits (documentation, databases, reports, subcontractors, sites, vendors, subsidiaries, foreign offices of KCR, processes and systems) to ensure compliance with law and regulations, SOPs and applicable guidelines
- Preparation of reports from audits along with suggestions for corrective actions, reviewing reports of audits conducted by QA personnel
- Assisting in preparations of investigational sites for audits by sponsors and/or regulatory authorities, providing assistance to the auditors
- Establishing and maintaining the organization of SOP
- Supervision over periodical reviews of SOP, distribution, approvals and tracking of SOPs and other process documentation (manuals, instructions, guidelines) in Quality Management System
- Development of new and reviewing the existing SOPs of KCR, assisting in reviewing and development of new policies and guidelines
- Assisting KCR departments in implementations of SOPs
- Ensuring that ISO certification requirements are implemented and followed in KCR
- Coordination of all activities related to ISO certification
- Maintaining full knowledge of all standards, procedures and guidelines as well as FDA, EMA and local regulations that affect clinical research operations
- Preparations of Yearly Quality Assurance Plans and submitting them for approval by the Board
- Notifying immediately about any significant QA discrepancies which could affect a study, a project or company operational integrity
- Acting as primary coordinator and representative of QA within assigned project groups, assists in development and execution of quality assurance plans per projects
- Acting as primary contact for customers in QA/QC aspects, liaising with internal and external customers in scope of audits
- Preparations of KCR's offers to be submitted to clients, in scope of QA/QC
- Providing training sessions on topics related to QA
- Preparations, planning, performing, following-up and controlling over the processes of CAPA implementation
- Managing, training, evaluating and developing Auditors, Senior Auditors and other Quality Assurance and Compliance Department staff
**Education / Qualifications / Skills Requirements**
- University degree
- Minimum of 2 years auditing experience in medical/pharmaceutical field plus 5 years of relevant experience in clinical research
- Minimum of 3 years supervisory experience of clinical research and QA personnel
- Knowledge of GCP, GMP and GLP regulations
- Knowledge of ICH guidelines and clinical research process
- Basic statistical knowledge
- Fluency in English
- Excellent written and oral communication skills
- Sound judgement to evaluate discrepancies, make decisions and report findings
- Ability to produce quality reports and written communication
- Proficiency with computing software and knowledge about computer systems validation process
- Confidence and enthusiasm
- Flexibility and willingness to work in a team environment
- Availability for business travelling
**At KCR** we put our mission**:WE SEE HUMAN BEHIND EVERY NUMBER** into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To demonstrate how appreciated your talent and your commitment are, KCR is offering you:
- 1 additional day off for your birthday;
- Loyalty Bonus Program (anniversary award or additional anniversary paid time off);
- Referral program;
- Additional PTO days during Christmas period;
- Onboarding process and induction training to develop deep sector knowledge and complex skills;
- Latest technology and the most advanced equipment and working tools;
- An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement;
- Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.
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