Key Responsibilities
Reporting to the Head of QA Russia, key responsibilities will include:
- Market compliance to ensure that product which is manufactured by or on behalf of Veropharm and placed on the market by or on behalf of Varopharm is compliant with local regulation and Abbott standards and to address appropriately any potential on market compliance issue once identified.
- Compliance with all relevant regulations at manufacturing sites, Third party manufacturing sites, affiliate, supply chain & suppliers for Russia.
- Ensures development / continuous improvement and implementation of necessary PV/GCP/GLP systems for Veropharm to ensure compliance to regional regulations and EPD QA requirements.
- Leading the manufacturing site QA, third party manufacturing QA team, commercial & distribution QA team supporting compliance for Veropharm, which is critical to the safety and regulatory compliance for pharmaceutical products in Russia.
- Develop robust quality systems to ensure implementation and maintenance of a cost-effective, appropriate & relevant strategy to maintain compliance and product quality for Russia market and any additional markets served by product manufactured by Veropharm
- Ensure product quality compliance aspects for Product Portfolio Expansion initiatives.
- The position requires strong leadership skills in order to communicate with senior management highlighting the strategic need for defined, relevant, effective QA programs and elevating potential on market issues and associated actions and recommendations.
- Maintain a highly-motivated group with correct knowledge and skill set, ensuring the team is working to maintain compliance with all required regulations.
- Accountable for the direction and implementation of the quality/compliance aspects for Veropharm manufacturing sites, contract operations, supply chain and all associated quality systems.
- Responsible for quality systems which ensure that Veropharm pharmaceutical products meet all regulatory and safety requirements.
- Ensure optimal organization design to support needs of the changing business
- Ensure on time product disposition; New product introductions; Validation; Auditing; QA IT systems.
- Keep current about developments within related domains of expertise, via literature, conferences and contacts with universities, business schools, consultants, certification bodies and/or authorities.
- Assess the (future) impact of trends and changes in governmental policies and regulations, on the Abbott (EPD) business within own perimeter.
- Defines in collaboration with the key stakeholders (commercial, manufacturing, development, legal and regulatory organizations) — the local and global quality/compliance programs.
- Present and defend to regulatory authorities and alliance partners, company’s policies and practices related to QA/QC.
- Ensure that all relevant employees at the sites and contract partners are trained appropriately in GMP.
- Prioritize local and country level Quality activities and define deliverables.
- Monitor project spending and report anticipated deviations at own (global/local) level.
- Represent the department within the management teams.
- Keep internal and external counterparts regularly informed.
- Ensure the exchange and distribution of information and expertise within the teams.
- Ensure that appropriate Quality resources at sites.
- VPH Quality budget responsibility and provide updates/report deviations.
- Responsible for significant event elevation related with Veropharm and TPM products and communication to external authorities.
Education
- Bachelor’s degree or university in chemistry, (micro-) biology or pharmacy, chemical – technology.
Background
- 15+ years’ experience in Quality Department in manufacturing sites (Pharmaceutical industry).
- At least 7 years on management position in Pharmaceutical industry (Quality, Manufacturing, Project Management).
- Currently qualified QP in Russia and in EEU QP in future.
- Extensive knowledge GxP regulatory requirements and industry best practices.
- Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
- Extensive Knowledge of international and local quality system and compliance legislations and standards. Good knowledge of Pharmaceuticals production process, Pharma Quality standards, Pharma Quality systems management.
- Detailed knowledge of inspection and auditing standards. Experience in communication with National and International Health Authorities
- Change Management skills.
- Knowledge of Audit methods
- Troubleshooting and issues resolution skills
- Project management expertise
- Perceptual and analytical problem solving related to: removal of obstacles, setting priorities, people, resources and facilities involvement.
- Ability to communicate affectively, both orally and in writing for both technical and non-technical audience.
- Good Negotiation skills.
- Risk assessment, Analytical thinking, Business Awareness.
- Impact & Influence, Planning & Organizing.
- Russian and English languages – fluent
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