Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Product Development QA Manager
Location: Belgrade

Job summary:

As the Product Development QA Manager, you will be responsible for developing and improving the PD QA processes and team capabilities. Your tasks include defining the quality management system for product development, ensuring compliance with STADA global external supplier organization (ESO) Policies, and monitoring the performance of strategic contract development manufacturing organizations (CDMOs). You will collaborate with cross-functional teams, foster talent development, and drive process improvements. This role offers an exciting opportunity to make a significant impact on our product development projects.
 

Your tasks and responsibilities:

PD Quality:

• Develop and continuously improve the PD Quality organization and the capabilities of the team
• Defining the quality management system for the product development activities and establish the documentation system associated.
• Ensure STADA global ESO Policies and Standards will be implemented in both, internal development sites and CDMOs.
• Participate in the selection, evaluation, and qualification of strategic CDMO’s for new product developments
• Continuously monitor the qualification status and performance of the strategic CDMOs.
• Support PD organization during the execution of the PD projects with all the quality related questions and issues.
• Ensure the knowledge transfer from the product development stages to the commercialization phase and along the product life cycle.

Organization

• Co-operates with quality and product development organizations across sites, affiliates and within Global Quality and Global Product Development

People

• Develops the Product Development Quality team, thorough succession planning, talent management and individual development plans
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through training and development, coaching and mentoring and performance management.
• Develops and implements annual goals for the direct reports and monitors target achievement and performs the annual performance review for the direct reports

Reporting

• Communicates with strategic stakeholders’ key performance indicators and quality related matters

Projects

• Drives process improvements by applying recognized quality tools, internal and external audit programs, appropriate feedback systems
• Participates in global projects and ensures timely implementation

Requirements:

• University degree in pharmacy, technology, or comparable course of study
• Minimum 5 years of work experience in biopharmaceutical industry or pharmaceutical industry with knowledge in biotechnology
• Previous experience in Quality and/or Pharmaceutical Development
• Sound knowledge of the relevant US & EU regulations, EMA, FDA and other regulatory standards regulations in the biotechnological and pharmaceutical industry.
• You demonstrate a highly self-organized nature and strong organizational skills (previous experience in Project Management would be considered as advantage)