Manager Quality Services, Third Party Audits

卡湯晩; Barcelona; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading global life sciences company is seeking a Manager for Quality Services, focusing on third-party audits. The role involves ensuring compliance with quality standards, conducting audits, and supporting quality improvements in manufacturing processes. Ideal candidates will have extensive experience in the pharmaceutical industry and strong problem-solving skills.

Formación

• Minimum 4 years in Compliance or Auditing.
• 7-10 years in the pharmaceutical industry.

Responsabilidades

• Provide QA and technical support to Third Party Manufacturers.
• Ensure compliance with QA policies and regulations.
• Conduct on-site and remote audits of vendors.

Conocimientos

Problem-solving

Decision-making

Attention to detail

Organizational skills

Multitasking

Team-oriented

Proactive work approach

Educación

Master’s or Ph.D. in Life Sciences

Descripción del empleo

Manager Quality Services, Third Party Audits

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, including human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes, cardiovascular solutions, and consumer healthcare. With over 110,000 employees across more than 100 countries, Sanofi is dedicated to making a difference in patients’ lives worldwide and is recognized as a leading pharmaceutical company pioneering AI applications and data standards to accelerate global health impact.

The Global M&S Services team supports global M&S initiatives in partnership with Business and Digital teams, driving transformative projects and ensuring adherence to global quality processes.

Main responsibilities

1. Provide QA and technical support to Third Party Manufacturers (TPM) and Contract Manufacturing Organizations (CMO), including operations, affiliates, and stakeholders.
2. Ensure compliance with corporate and divisional QA policies, procedures, standards, specifications, and country-specific regulations based on TPM locations and markets.
3. Identify and resolve quality gaps related to product design, manufacturing quality programs, and product start-ups at TPMs.
4. Maintain overall quality and safety of products manufactured at these facilities.
5. Apply QA systems and problem-solving tools to address quality issues with alternative solutions.
6. Manage supplier audits, ensuring compliance with cGMP and SOP standards.
7. Monitor market developments and regulatory changes.
8. Follow up on CAPAs to ensure closure and effectiveness.
9. Participate in audits and inspections, liaising with specialists as needed.
10. Assess supplier quality regarding material compliance and regulatory CAPA before communicating with request sites.
11. Act as a local quality contact between Suppliers, Global Quality Suppliers, and IA sites to facilitate quality improvements and information exchange.
12. Support audits led by other auditors when specific expertise is required.
13. Conduct on-site and remote audits of GxP and health-regulated third-party vendors to ensure compliance.
14. Collaborate regionally to prepare for inspections.

About you

Experience:

• Minimum 4 years in Compliance or Auditing
• 7-10 years in the pharmaceutical industry
• Thorough knowledge of cGMPs and CFR regulations related to drugs and biologics
• Experience in conducting audits, inspections, and facing regulatory audits
• Knowledge of CAPA systems is desirable
• Experience managing third-party manufacturers or CMOs preferred
• Experience working on manufacturing sites is an advantage

Skills:

• Excellent problem-solving and decision-making skills
• Proficiency in risk-based decision making
• Attention to detail, organizational skills, and ability to multitask under stress
• Team-oriented and proactive work approach

Education:

• Master’s or Ph.D. in Life Sciences, Healthcare, or related field

Languages:

• Excellent command of English (spoken and written)

Progress doesn’t happen without people – people from diverse backgrounds, locations, and roles, united by a desire to make miracles happen. Join us in pursuing progress and discovering the extraordinary.

We are committed to equal opportunity employment regardless of race, color, religion, sex, national origin, sexual orientation, age, disability, or gender identity. Learn more about our diversity initiatives at sanofi.com.