Senior Manager, Quality Operations

Senior Manager, Quality Operations

Job title: Senior Manager, Quality Operations

Location: Singapore

Hiring Manager: Head of Quality

Mission

Sanofi is preparing its future through an ambitious program named MODULUS. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help Modulus to reach its ambition.

About the job:

Key Accountabilities

The mission described below must be exercised in compliance with health, safety and environment of the site rules.

• Responsible to shape, influence and provide quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations at Modulus Singapore manufacturing facility.
• Accountable to ensure all quality related operational procedures, infrastructures are successfully implemented to support Modulus Singapore site operational and inspection readiness and success.
• Coach and mentor cross functional team members with the goal to establish an engrained quality culture across the organization.
• Key quality representative to resolve complex issues, and participate in root cause investigations.
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
• Strategizing, reviewing and approving playbooks for direct manufacturing related topics to ensure the success of regulatory inspections and site audits.
• Lead and participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
• Escalate significant quality issues to Quality management in a timely manner.
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• Contribute to reach the Sanofi Manufacturing 4.0 ambition through a Quality plan.

About You:

Education and experience

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
• Minimum of 10-12 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry.
• Minimum of 5 years of managerial experiences to lead a team effectively in a matrix environment.

Key technical competencies and soft skills:

• Manufacturing 4.0 mindset.
• Knowledge of regulations and standards of the pharmaceutical industry.
• Solid manufacturing process technical knowledge.
• Broad and in-depth understanding of QA Operations.
• Strong interpersonal relationships.
• Discipline and assertiveness in decision-making.
• Familiarity with electronic batch record (MES) and lot disposition process using SAP system.
• Strong leadership skills.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills.
• Good understanding of risk-based decision framework.
• Experience in working internationally and cross-functionally.
• Familiar with Digital 4.0 concepts.

Pursue progress, discover extraordinary

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.