QA Biological Lead & Qualified Person

WE ARE HIRING!

QA Biological Lead & Qualified Person 

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 looking for a Biological QA Lead + QP based in Barcelona (hybrid role)

Your Mission:

The QA Biological Lead & Qualified Person ensures end-to-end quality and regulatory compliance for assigned biological products manufactured by external CMOs. The role maintains and continuously improves the Quality Assurance system in line with GMP, GDP and ICH guidelines, ensuring products are manufactured, tested and distributed according to their intended use and Marketing Authorisation. 

As the quality lifecycle expert for assigned molecules, finished dosage forms and markets, the role manages manufacturing and testing changes, quality incidents, new API sources and other changes affecting external manufacturing. The position also contributes to building and improving global corporate quality standards. 

As Qualified Person, the role is responsible for batch certification and market release, effective communication with Health Authorities on potential quality matters, and the coordination of marketed-product recalls.

Your Major Accountabilities:

As a Quality Assurance in Biological section: 

• Reviewing and approving GMP and technical documentation from CMOs, including SOPs, master batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, Quality Agreements and environmental conditions. 


• Managing and monitoring CAPAs, deviations, OOS, complaints and change controls. 


• Supporting, executing and reviewing qualification and validation activities for equipment, utilities, facilities, processes, cleaning, storage and distribution. 


• Preparing, reviewing and approving Product Quality Review reports and performing compliance checks between internal procedures and filed documentation. 


• Conducting internal and external audits and supporting Health Authority and customer inspections. 


• Preparing and delivering GMP training. 


• Supporting quality-related requests for marketed products and contributing to assigned cross-functional and Quality projects. 

As a Qualified Person: 

• Certifying and releasing commercial and clinical-trial batches, declaring psychotropic substances, coordinating recalls and acting as a contact with Health Authorities. 


• Ensuring release and certification activities comply with applicable legislation, including RD 824/2010, Article 18, and EudraLex Annexes 16 and 21. 


• Participating in assigned projects and providing Qualified Person expertise throughout product lifecycle activities. 

Your Specific Accountabilities: 

• Ensuring the successful worldwide launch of Briumvi (ublituximab). 


• Overseeing product quality and drive continuous improvement. 


• Supporting assigned Product Lifecycle projects. 


• Overseeing CMO activities and manage supplier qualification. 


• Supervising and support a team of 1–2 direct reports. 

We would like you to have:

• University degree in Pharmacy and a Master’s in the Pharmaceutical Industry are desirable


• At least +8 years of experience in Quality Assurance and +3 year as a Qualified Person experience with biotechnological products are preferred.


• Strong knowledge of GMP and Quality Management Systems


• Confidence using Microsoft Office, SAP and LIMS


• Professional fluency in English and Spanish


• Strong analytical thinking, problem-solving, initiative, results orientation, quality orientation, communication and attention to detail


• Availability for occasional travel to attend training and conduct audits


• An open mindset and readiness to embrace new projects and change

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 40 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, one in Australia, 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 (formerly Laboratories Lesvi) 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, a 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.

✓  Availability for occasional travel to attend training and conduct audits. 

✓  An open mindset and readiness to embrace new projects and change.