Global Senior GMP Auditor

Sandoz Iberia; Madrid; Presencial; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Sandoz Iberia is seeking a GMP Senior Auditor to lead GMP audits across sites, development centers, quality systems, and suppliers. You will review corrective-action plans and drive risk-based remediation within the Sandoz QMS.

Requirements include a degree in Chemistry/Pharmacy/Biology/Engineering, 10+ years in pharma/medical devices, strong regulatory knowledge, excellent English, and willingness to travel about 60%. Mentoring and continuous improvement are key parts of the role.

Formación

• Requires degree in a related science with advanced degree preferred
• Minimum 10 years in Pharmaceutical or Medical Device industry
• 3 years auditing experience preferred and strong regulatory knowledge
• Willingness to travel ~60% of the time

Responsabilidades

• Lead, support and report independent GMP audits across sites, development centers, QA systems and suppliers
• Review and approve corrective action plans and ensure timely remediation
• Provide guidance and training on audit activities and regulatory requirements
• Mentor junior GMP staff and transfer best practices to the QMS

Conocimientos

English communication

Interpersonal skills

Regulatory interpretation

Leadership

Mentoring

Travel readiness

Educación

Degree in Chemistry/Pharmacy/Biology/Engineering

Descripción del empleo

At Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:

• finding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.
• to protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity and inclusion across our company and beyond

As GMP Senior Auditor you'll lead, support and report independent GMP audits according to the Sandoz Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers. Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Sandoz business units through risk based assessments. Act as SME for assigned areas of responsibility.

Your Responsibilities Will Include

• Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
• For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.
• Provide technical guidance, mentoring, and training on audit activities.
• Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
• Prepare audit reports according to Sandoz requirements and timelines.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
• Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system
• Review and advise on relevant policies and procedures.
• Mentor junior GMP staff as required.
• Maintain current knowledge of regulations, standards, and guidance documents.
• Identify and report best practices and lessons learned to support development/training of GMP auditors.

What You Need To Bring To The Role

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted
• Excellent oral and written English communication skills. Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is valued.
• At least 10 years broad experience in Pharmaceutical or Medical Device Industry.
• The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
• 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
• Willingness to travel approximately 60% of the time.
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and standards
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision
• Excellent leadership and facilitation skills

What You’ll Receive

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Commitment To Diversity & Inclusion

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

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

#Sandoz