Corporate Quality Nitrosamine Specialist

WE ARE HIRING!

CORPORATE QUALITY NITROSAMINE SPECIALIST

Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause!

Neuraxpharm is seeking a Corporate Quality Nitrosamine Specialist to strengthen our Corporate Quality team. Given the highly specialized nature of the role, based in Europe.

Your mission:

Reporting to the Corporate Quality Project Lead, you will serve as Neuraxpharm’s expert in nitrosamine risk management across all group products (APIs and FDFs). This includes leading risk analyses, defining mitigation strategies, supporting analytical method development, and collaborating closely with CMOs, CROs, laboratories, and regulatory bodies. Your expertise will be essential to ensure product safety, compliance, and continuous improvement.

Your major accountabilities:

• Become Neuraxpharm’s reference expert in nitrosamine science, staying ahead of evolving regulatory expectations (EMA, FDA, Pharmacopeias, country‑specific guidance) and translating them into clear, actionable quality strategies.
• Drive and own the full nitrosamine risk‑management lifecycle, from risk identification and assessment to approval and root‑cause resolution—ensuring robust product safety and regulatory readiness.
• Design and implement mitigation strategies that meaningfully reduce nitrosamine levels in finished dosage forms—acting as the primary interface with global health authorities whenever technical clarification or supporting evidence is required.
• Lead and elevate the analytical rigor of the organization by reviewing and guiding analytical method validation (HPLC‑MS) and method transfer activities for APIs and FDFs, ensuring they meet the highest scientific and regulatory standards.
• Champion scientific excellence and documentation quality, producing high‑quality technical reports, SOPs, and managing all key quality documentation from CROs and CMOs.
• Oversee and guide experimental work carried out by CMOs and external laboratories, interpreting raw analytical data and progressively becoming the internal subject‑matter expert for your assigned products.
• Ensure smooth project execution by coordinating all analytical materials (standards, reference samples, HPLC columns, etc.) and acting as a trusted partner across cross‑functional and external teams.

We would like you to have:

• A degree in Pharmacy, Chemistry, or a related field (postgraduate specialization preferred).
• 1- 3 years of experience in QC, QA, or Manufacturing Specialist or external consultant in the pharmaceutical industry with experience in conducting Nitrosamine risk, root‑cause analysis, stability studies, nitrosamine mitigation strategies (e.g., scavengers).
• Solid knowledge in GMP, HPLC‑MS, GLPs, Pharmacopoeias and ICH guidelines.
• A strong foundation in toxicology principles and regulatory frameworks is highly valued.
• A highly analytical mindset, strong problem‑solving capabilities, quality orientation, attention to detail, and the ability to work independently with scientific rigor.
• Comfort working with scientific and technical documentation and tools such as MS Office and LIMS.
• The ability to collaborate across geographies and thrive in multicultural environments.
• Proficient English and availability to travel up to 10%.

ABOUT US

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals in Spain.

Be part of the team where you can count on us to deliver:

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, a result focused and an expert & excellent team!

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com

If you want to join us, this is your opportunity!

WE COUNT ON YOU, YOU COUNT ON US

At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.

We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.

We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.