Quality Manager - Escalation and Regulatory surveillance

MISSION STATEMENT

We are a Corporate quality team governing major and critical quality incidents requiring escalation - we drive the assessments of quality issues raised within Zentiva product supply and commercial operation to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well as consistency in assessment and documentation for all quality incidents.

Our team is in liaison between quality and commercial / business stakeholders to ensure satisfactory management of quality issues. We ensure implementation of corporate quality system requirements , tools and procedures at affiliate quality management systems (QMS) including its evaluation, as well as communication and training within Zentiva organization.

MAIN ACCOUNTABILITIES AND DUTIES

Key point of contact for information on escalation process and determination of issue criticality and categorization of issues, subsequent steps, and mitigating actions.

Identifying stakeholders for discussion and decision making incase of escalations and manage the escalation meeting including the issuance of meeting minutes.

Develop and maintain Guidelines / SOPs for escalation management including templates for investigation report, presentations, meeting minutes, and HA notifications.

Ensure event record is raised, maintained, and completed in a timely manner meeting Good Documentation Practices and per processes for incidents in scope escalation management team.

Update the organization with new regulations / requirements applicable to Genotoxic Impurities (Eg. Nitrosamine Impurities) and oversees the activities within Quality organization.

Coordinates review and approvals of procedures , methods, analytical method validations with external or internal laboratories, risk assessments, investigation reports, change requests, etc with respect to Nitrosamine Impurities.

Standardize the management of Genotoxic impurities management and improvise if needed.

As an escalation process SME, drive timelines for process steps .

Lead and manage Health Authority reporting as needed to ensure reporting is completed in a compliant manner.

Support completion of monthly escalation updates on escalations (incidents).

Develop and maintain a network of key stakeholders in Zentiva to ensure appropriate input and support of quality issues.

Lead active surveillance and analysis of emerging regulations , suspension of EU GMPc & warning letters, perform impact assessments and drive process changes required to ensure ongoing compliance to regulatory requirements. Analyze the impact of other Zentiva processes and organizational changes on assigned processes.

Develop and maintain Guidelines / SOPs for regulatory surveillance process.

Assess and comment escalation before communication to target markets authorities and customers.

Assure assessment and benchmark of similar cases among sites and affiliates to minimize duplicity in investigation and improve overall effectiveness.

SME and provide support in case of authority inspections at market level.

Prepare regular reporting in respective area.

Establish KPIs and ensure KPIs are met for escalation (Genotoxic & other escalations) and for Regulatory Surveillance.

OTHER RESPONSIBILITIES

QUALITY : Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE : Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE : All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE : The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her / himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

SUSTAINABILITY : Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet.

MANAGERIAL POSITION REQUIREMENT : Good communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project / acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

Technical University Degree (health, pharma, technical, chemical areas are advantage).

10+ years industry experience specifically in GxP with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.

Strong experience in area of GxP related to change control, deviation, quality processes and document management.

Organizational and analytical skills associated with a proficiency in quality management and continuous improvement.

Critical thinking ability and risk management and risk- based knowledge and approach.

Ability in partnering with a proactive and solution- oriented approach.

Strong skills to facilitate / optimize contribution of team members as individuals and members of a quality function.

Ability to work effectively in a matrix cross-functional environment .

Strong capacity for working independently with minimal supervision.

Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking).

Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.

WHAT IS IN IT FOR YOU

An opportunity to work for a  successful international pharmaceutical company .

An opportunity to  learn newest approaches in managing creative and highly adaptive business organizations.

Pleasant and dynamic working environment .

Continuous personal development .

An attractive compensation & benefits package .

Above standard social and benefit program .