Director Quality Operations

2 weeks ago


Singapore MSD Full time

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.

The position of Director, Quality Operations, plays a significant role in the definition of the quality strategy and key business objectives and has a strong direct impact on the execution of strategy. The role sits as a key succession role for the Site Quality Head and the incumbent is a key member of the Quality Leadership team, leading diverse teams providing end to end services to IPTs.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**This role is responsible for**:

- End to End oversight across Quality Operations for the Singapore facility which includes multiple product modalities
- Leading a team of Associate Directors and Senior Managers, responsible for Quality Assurance and Quality Control, with oversight across operations including various quality labs supporting IPTs e.g., API/Incoming/OSD/Component labs, Batch Review/Release, Floor Support, Deviation Management and change control.
- Responsible for the overall strategy, performance, and results, while driving site quality culture
- Driving collaboration and transformational culture change

**Key Responsibilities, all or subset of the below**:

- Setting overall strategy and direction of quality operations, aligned with business vision and plan
- Lead a team of Quality leaders and managers to ensure successful outcomes aligned with business strategy
- Overall responsibility inspiring the quality operations organization and developing leaders, career pathing, and building strong succession plans for future
- Engagement and stakeholder management is an essential part of the role, working with IPT leader and cross functional and functional business leaders for overall quality operations, including financial targets and efficiency and productivity KPIs
- Accountable for the change control and management of above site escalations, including risks and issues management
- Actively identify opportunities to collaborate with business and other Quality Directors and encourage/support teams for continuous improvement
- Lead and drive site quality culture

**What are we looking for?**

**Qualifications & Experience**
- Bachelor or Master’s degree in Science/ Life Science, Pharmaceutical Science or Engineering or proven relevant experience.
- 12-15 years of applied professional work experience in the following pharmaceutical work areas: quality operations, quality support and compliance
- Demonstrated experience in business and functional strategy and key strategic objectives / metrics while aligning priorities and resources to deliver on commitments
- Leading change and project management for large teams of above 100 employees, with ability to lead a cross functional high-performance team
- Experience in leading quality operations and knowledge of regulatory standards, compliance procedures and quality systems especially for Singapore, EU, or US markets

**Personal Qualities**
- Demonstrated people management skills and ability to influence/collaborate with senior stakeholders
- Customer focus with strong business acumen and continuous improvement mindset
- Strategic and critical thinking mindset with a collaborative and problem-solving attitude
- Experience with project and change management
- Coaching and mentoring with a focus on creating an inclusive quality culture

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

**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



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