Senior Manager, Quality (Regulatory Complinace and System)

MSD; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

MSD is seeking a senior quality assurance professional in Singapore, responsible for managing regulatory inspections and audits, improving quality systems, and fostering a strong quality culture. Candidates should possess extensive experience in pharmaceutical manufacturing quality assurance, along with a relevant degree. This role supports critical supply chains to ensure high-quality medicines and vaccines for patients worldwide.

Qualifications

• At least 8 years of relevant experience in quality assurance within pharmaceutical manufacturing.
• Auditor experience supporting health authority inspections with knowledge of regulatory requirements.
• Ability to establish high audit performance systems and workflows.

Responsibilities

• Manage regulatory audit preparation and commitments to ensure compliance.
• Support QMS implementation and oversee SOP system management.
• Lead site quality culture and coaching for team members.

Skills

Regulatory audit management

Quality Risk Management

Project management

Continuous improvement

Communication

Education

Bachelor's or Master’s degree in Science, Life Science, Pharmaceutical Science, Engineering

Job description

We are committed to providing 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 a key strategic manufacturing site 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 be responsible for:

• Successful audit management for regulatory inspections
• Management of regulatory commitments to avoid overdue items
• Driving transformational culture change
• Ensuring the site develops and maintains a culture of inspection readiness

Key Responsibilities

• Develop effective and focused regulatory inspection preparation plans to ensure successful inspection outcomes
• Manage preparation work for corporate and regulatory audits, including internal audits. Monitor and manage regulatory commitments to ensure they are fulfilled systematically, timely, and accurately, ensuring continued product registration. Manage site quality council meetings and ensure timely collation of site/quality metrics for reporting to management.
• Support the rollout and management of corporate quality automation systems to ensure proper system design, maintenance, and control, complying with corporate policies and internal requirements.
• Ensure effective management of Quality Management System (QMS) implementation and Quality Risk Management to maintain site compliance with corporate policies, acting as the site expert on quality risk management.
• Manage the site SOP system to ensure development, maintenance, control, and distribution comply with regulatory and corporate requirements.
• Collaborate with Regulatory Affairs and CMC teams on product submission strategies to ensure product filings are fit for their intended use.
• Provide management, coaching, and mentoring to a team of associates
• Offer expertise on the application of ICH guidelines, applying QbD principles in quality systems integration and adaptability
• Identify and pursue opportunities for continuous improvement
• Lead and promote a site quality culture

Qualifications & Experience

• Bachelor's or Master’s degree in Science, Life Science, Pharmaceutical Science, Engineering, or relevant experience
• Audit experience and support for health authority inspections, with knowledge of Singapore, US, European, and Russian regulations
• At least 8 years of relevant experience in quality assurance or related functions within pharmaceutical manufacturing for highly regulated markets (FDA, EMA)
• Project management skills and knowledge of system lifecycle management are preferred for automation system rollouts
• Ability to establish systems and workflows ensuring high audit performance and efficiency

Personal Qualities

• Strong management and communication skills
• Ability to work independently
• Meticulous with high integrity
• Excellent organizational 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 elsewhere. For over a century, we have been inventing for life, bringing medicines and vaccines for many challenging diseases. We continue to lead in research to deliver innovative health solutions and advance disease prevention and treatment worldwide.

What we look for

Imagine waking up each day to a job that helps save and improve lives globally. Here, you can apply your empathy, creativity, digital mastery, or scientific genius in collaboration with diverse colleagues who pursue and bring hope to those battling severe diseases. Our team is evolving; if you are curious and driven, join us and start making an impact today.