We are committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Our global supply strategy relies on manufacturing capabilities and expertise to achieve this mission. Singapore is one of the key strategic manufacturing sites for our company and our patients. The local site operates complex, multi-product facilities that manufacture active pharmaceutical ingredients, oral solid dosage, inhalation, and sterile drug products.

In this role, you will also be responsible for:

• Successful audit management for Regulatory Inspections
• Management of regulatory commitments to avoid any overdue
• Drive transformational culture change
• Ensure the site develops and maintains a culture of inspection readiness

Key Responsibilities

• Strategize and develop effective and focused regulatory inspection preparation plan to assure successful regulatory inspection outcomes
• Manage preparation work for corporate and regulatory audits, including internal audits. Monitor and manage regulatory commitments made to regulatory agencies to ensure these are fulfill in a systematic, timely and accurate manner so as to ensure continued registration of our products. Manage site quality council meeting and ensure on time collation of site/ quality metrics for reporting to site and corporate management.
• Support the roll out and manage effectiveness of corporate quality automation systems to ensure adequate system design, maintenance and control which is complying with the corporate policies of automation system lifecycle and internal requirements. - 1 - INVENT. IMPACT. INSPIRE.
• Ensure effective management of Quality Management System (QMS) implementation program and Quality Risk Management to ensure site compliance to corporate policies, as site expert on quality risk management
• Provide an effective and efficient site SOP management system to ensure the developing, maintenance, control and distribution of SOP complies with regulatory and corporate requirement.
• Proactively liaise and work with Regulatory Affairs, CMC on product submission filing strategy on behalf of site, assuring product filing is fit for its intended use.
• Provide effective management, coaching and mentoring of a team of associates
• Provide subject matter expertise on the practical application of ICH guideline. Applies QbD framework and principles in the integration and adaptability of key quality system.
• Actively seek opportunities for continuous improvement
• Lead and drive site quality culture

Qualifications & Experience

• Bachelor or Master's degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
• Audit experience and supporting health authority inspections required with good knowledge of Singapore, US, European and Russian regulatory requirements
• 8 years or more of relevant experience in a quality assurance and other function (e.g. operations, technical, regulatory affairs, etc.) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
• Project management skills with good knowledge of system lifecycle management is preferred for the roll out of corporate automation systems
• Capable of establish systems and ways of working to ensure high audit behaviours and efficiencies

Personal Qualities

• Strong management and commuR337930 Sr. Manager, Quality(Reg Comp&Systems)ication skills
• Able to work independently
• Meticulous with high integrity
• Strong organizing and time management skills
• Positive attitude and self‐motivated

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.