Site Quality Head

2 weeks ago

Bucharest, Bucureşti, Romania Zentiva Full time €90,000 - €120,000 per year

Zentiva is a Pan-European Platform developing, manufacturing, and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We are offering solutions in key therapeutical areas like Cardiology & Circulation, diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.

The Site Quality Head of Bucharest Sites leads the quality organization and is responsible to plan and verify Quality Management Systems (QMS) Quality Assurance (QA) and including Quality Control (QC) to ensure compliance to local and international regulatory requirements including licensing, GMP and regulatory requirements.

The Site Quality Head ensures the most effective deployment of resources in QA and QC areas and has responsibility for batch disposition decisions. The Site Quality Head works toward formulating the sites quality strategy and actively contributes to realize the sites vision living the company values and Code of Ethics.

KEY RESPONSIBILITIES AND ACTIVITIES

  • Act as Quality Management representative to the Site Management
  • Review and approve Master manufacturing and Laboratory Control documents to ensure compliant and appropriate registration of the sites activities
  • Responsible for staffing, employees development, talent assessment, performance management, succession planning, discipline and recognition
  • Plan and prepare training material related to Quality and ensure appropriate training of associates. Ensure continued training of personnel as well as monitoring of training status
  • Design and implement the QMS of the Bucharest sites complying to the requirements under Zentiva Guidelines, international quality standards and applicable regulatory requirements
  • Plan for the qualification, approval and monitoring of vendors, suppliers and contractors and ensure the review and approval of Technical and Quality Assurance Agreements
  • Ensure the timely and compliant investigation of events (deviations, out of specifications, out of trend and market complaints) and the definition of appropriate action plan for corrective and preventive actions

REQUIRED QUALIFICATIONS AND EXPERIENCE

  • Advanced knowledge of
    English
    and
    Romanian
  • University degree in Pharmacy, Chemistry, Biology, or relevant Life Sciences
  • Minimum of 14 years of experience in GMP quality operations with previous top management experience having at least 4 years of people management experiences
  • Proven leadership skills, including the ability foster a culture of quality excellence
  • In-depth knowledge of quality management and international quality standards such as GMP, ICH and relevant regulatory requirements
  • Experience in transformation, working in dynamic environment and demonstrated ability to empower and motivate others
  • Collaborative and team-spirited

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