Quality Manager, EM CHC - ASEA & AU

• Location: Jakarta, Indonesia
• Job Type: Permanent, Full-time

About the job

At Sanofi Consumer Healthcare, we believe in empowering individuals and communities through trusted, high-quality healthcare solutions. We offer a supportive and collaborative work environment, a comprehensive rewards package, and opportunities for professional development to help you grow your career.

We are looking for a dedicated Quality Manager to join our External Manufacturing CHC AMEA (ASEA & AU) team based in Jakarta, Indonesia. As part of our External Manufacturing team, you will contribute to building better, more sustainable healthcare practices across the ASEA & AU region. In this role, you will be responsible for providing quality oversight of Contract Manufacturing Organisations (CMOs), third-party manufacturers, and suppliers within the ASEA & AU region. Your key focus will be ensuring compliance with Good Manufacturing Practices (GMP) and local regulatory requirements, while fostering collaboration to support continuous improvement initiatives.

This role requires effective communication in both Bahasa Indonesia and English to engage with internal teams and external business partners across the region.

Main responsibilities

1. Quality Management of Third-party Manufacturers:

• Conduct quality due diligence, evaluation, and approval of third-party manufacturers.
• Oversee audits, Corrective and Preventive Actions (CAPAs), complaints management, and product recalls.
• Manage quality agreements, change controls, and deviations to ensure compliance with local and international regulatory standards.
• Perform risk assessments and conduct quality reviews of third-party manufacturers.

2. Quality Operations for EM CHC ASEA & AU Entity:

• Support the development and continuous improvement of quality systems to ensure compliance with GxP and regulatory guidelines.
• Manage quality documentation and ensure appropriate retention and archival processes.
• Assist in the preparation of quality reports and Key Performance Indicators (KPIs) to monitor quality performance.

3. Quality Training:

• Manage and monitor GxP training curricula for relevant personnel.
• Support the development of training materials and ensure training records are maintained as per regulatory requirements.
• Contribute to increasing GxP awareness within the EM CHC AMEA hub.

4. Quality Technical Support:

• Provide technical advice on quality compliance and product-related matters.
• Collaborate on cross-functional projects such as new product launches and site transfers.
• Ensure ongoing quality oversight for third-party manufacturers to maintain compliance.

5. Other Responsibilities:

• Participate in quality reviews and audits as needed.
• Support transversal quality projects to align with business and regulatory requirements.

About you

Education:

• Degree in Pharmacy, Pharmaceutical Science, or a related field.

Experience:

• At least 8 years of experience in quality or manufacturing within the pharmaceutical industry.
• Minimum 5 years in a quality leadership or project management role.

Core Competencies:

• Strong leadership, organizational, and planning skills.
• In-depth knowledge of GMP regulations across relevant markets (ASEA, AU, EU, ICH, PIC/S).
• Effective communication skills in both Bahasa Indonesia and English.
• Ability to work both independently and within a matrix organization.
• Experience in internal and external audits, risk assessment, and root cause analysis.

Desirable Skills:

• Knowledge of non-sterile dosage forms and active pharmaceutical ingredients (APIs).
• Familiarity with CMC regulatory affairs.
• Project management skills.

Pursue Progress. Discover Extraordinary.

Join us to make a positive impact on healthcare quality in the ASEA & AU region. Together, we can achieve extraordinary results through continuous improvement and effective collaboration.