Product Quality Lead

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.; Sabadell; Ibrido; EUR 45.000 - 84.000; Tempo pieno

Vantaggi offerti da questo lavoro

Insurance plans

Retirement plans

Wellbeing resources

Hybrid working options

Global recognition programs

Descrizione del lavoro

Novartis Farmacéutica, S.A. in Barcelona, Spain, seeks a Product Quality Lead to provide end-to-end quality leadership across a global manufacturing and testing network.

Lead lifecycle quality activities, guide risk-based decisions, and ensure regulatory compliance and continuity of supply for Radioligand Therapy products. You will collaborate with cross-functional teams, oversee launches, tech transfers, and change controls, and support inspections readiness while upholding the highest quality

Competenze

• Extensive pharmaceutical/biopharmaceutical quality experience.
• Strong GMP knowledge and regulatory expectations.
• Experience with launches, regulatory changes, transfers and change control.
• Ability to assess complex information and influence stakeholders in global teams.

Mansioni

• Lead end-to-end quality oversight for Radioligand Therapy products across lifecycle.
• Represent Global Product Quality in cross-functional teams with clear guidance.
• Guide quality activities for launches, markets, tech transfers, and testing changes.
• Oversee significant product quality issues with timely risk assessment and escalation.
• Lead cross-site change assessments affecting quality, regulatory commitments and supply.
• Provide quality input for regulatory submissions and Health Authority responses.
• Identify emerging quality risks and apply science- and risk-based decisions.
• Support inspection readiness across the global network and Health Authority interactions.

Conoscenze

Quality leadership

Regulatory knowledge

Risk assessment

Cross-functional collaboration

Communication

Formazione

Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or another relevant scientific discipline

Descrizione del lavoro

Salary Range: €45,100.00 - €83,700.00

Job Description Summary #LI-Hybrid Primary Location: Barcelona, Spain Relocation Support:

This role is based in Barcelona, Spain. Novartis is unable to offer relocation support: please only apply if accessible. Help shape the quality journey of innovative Radioligand Therapy products from launch through their full lifecycle. As Product Quality Lead, you will provide end-to-end quality leadership across a global manufacturing and testing network, partnering with cross-functional teams to safeguard product quality, regulatory compliance and continuity of supply. You will guide critical lifecycle activities, anticipate and manage product quality risks, and bring a clear, science- and risk-based perspective to complex decisions. This is an opportunity to combine your quality expertise with broad global influence, helping ensure transformative therapies reach patients reliably and with the highest standards of quality.

Job Description Key Responsibilities

Lead end-to-end quality oversight for assigned Radioligand Therapy products throughout their lifecycle. Represent Global Product Quality in cross-functional teams, providing clear quality guidance and recommendations. Guide quality activities for launches, new markets, technology transfers, and manufacturing or testing changes. Oversee significant product quality issues, driving timely risk assessment, resolution, and escalation. Lead cross-site change assessments, evaluating impacts on product quality, regulatory commitments, and supply. Provide quality expertise for regulatory submissions, Health Authority responses, commitments, and lifecycle changes. Identify emerging quality risks and apply science- and risk-based decision-making to complex challenges. Support inspection readiness across the global network, including preparation, Health Authority interactions, and follow up.

Essential Requirements:

Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or another relevant scientific discipline. Extensive pharmaceutical or biopharmaceutical experience in quality, manufacturing, technical operations, or other regulated activities. Strong knowledge of current Good Manufacturing Practice and relevant global regulatory expectations. Solid understanding of pharmaceutical manufacturing, analytical testing, validation, quality control, and technology transfer. Experience supporting product lifecycle activities, including launches, regulatory changes, transfers, and change control. Strong ability to assess complex information, communicate clear recommendations, and influence stakeholders in global cross-functional environments.

Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. Expected Annual Base Salary Range for role: EUR 45,100.00 - 83,700.00 EUR The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .