Manager Global Quality Agreements

4 weeks ago

Timișoara, Romania STADA Hemofarm Full time

Hemofarm STADA is a member of the STADA group, one of the world's largest generic pharmaceutical companies, which successfully operates in the markets of Serbia and the Western Balkans. Hemofarm produces high-quality pharmaceutical products within the leading pharmacotherapeutic groups, respecting key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.
About Job
Join our international team at STADA Hemofarm in Timisoara, Romania, as the Manager Global Quality Agreements. In this pivotal role, you will collaborate with STADA Arzneimittel AG in Bad Vilbel, Germany, and other affiliates to ensure compliance with regulatory requirements and maintain the integrity of our manufacturing and supply processes.
Key responsibilities:

Contribute to creating and maintaining QTA-approved formats for APIs, CMOs, testing laboratories, warehouses, and suppliers.
Coordinate centralized GMP activities regarding Quality Technical Agreements and drive continuous process improvement.
Negotiate and conclude Quality Technical Agreements with various stakeholders, including manufacturers and service providers.
Support the global QTA network coordination, fostering information exchange and training across STADA affiliates.
Correspond with internal and external partners, representing the company in protocol relations.
Work in interdisciplinary teams to ensure activities align with SOPs and regulations.
Maintain confidentiality and ensure information integrity.
Participate in training programs and contribute to process improvement initiatives.
Assist in creating and assessing key performance indicators and initiating corrective actions.
Support the creation of global QTA presentations and perform other duties as assigned.

Requirements:

Bachelor's degree in a relevant field.
Proven experience in regulatory affairs or quality management in the pharmaceutical industry.
Strong negotiation and communication skills.
Excellent organizational skills and attention to detail.
Ability to work collaboratively and adhere to SOPs and regulations.
Proficiency in English is required.

 
Notes: Only CVs submitted in English will be considered for this position.

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