Pharmaceutical Affairs Manager | All genders | Full-time

Pharmaceutical Affairs Manager | All Genders | Full-time

Pharmaceutical Affairs Manager

Location: Vienna, AT

Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behavior at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

You will be responsible for managing the change control process, including evaluation, coordination, and documentation of changes. Updating, maintaining, and harmonizing SOPs, including the implementation of global procedures into the local Quality Management System (QMS). Managing Technical Quality Agreements (TQAs), including regular reviews and revisions. Acting as back-up for the management of deviations and complaints, ensuring compliant and timely handling. Supporting audit activities, including audit planning, execution, reporting, and follow-up of corrective and preventive actions. Supporting supplier qualification activities, including documentation review and coordination with internal and external stakeholders. Organizing and actively participating in cross-functional meetings related to the activities above.

You will need to have a university degree in pharmacy, chemistry, life sciences, pharmaceutical sciences, or a comparable scientific discipline with a relevant focus. Several years of hands-on experience in Pharmaceutical Affairs, Quality Assurance, or a comparable regulated environment. Proven practical experience with change control, SOP management, deviations, complaints, audits, and TQAs. Solid understanding of GxP requirements and quality systems in the pharmaceutical industry. Experience working with local and global quality processes and integrating global standards into local systems. Qualification as a Qualified Person (QP) is considered an advantage, but is not a prerequisite for this role. A collaborative, team-oriented mindset with the ability to work effectively in cross-functional environments. Strong communication and interpersonal skills, with confidence in interacting with internal and external stakeholders. A structured, reliable, and solution-oriented working style, combined with a high level of ownership. Fluent English, both written and spoken.

Location Vienna | Austria

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide a competitive salary package with a base salary starting from 64,400 EUR (actual salary will be depending on qualification and prior relevant experience), top-class benefits, work-life balance initiatives and development opportunities. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.