Executive Director, Quality Operations

4 weeks ago

Singapore MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) Full time
Roles & Responsibilities

Executive Director, Quality Operations

THE OPPORTUNITY

  • Great learning opportunities in a fast-paced environment with first hand encounter on real problems and high visibility on manufacturing operations.
  • Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.


WHAT YOU WILL DO

  • Provide leadership and management of all quality control, micro / sterile, quality assurance, and regulatory compliance functions to effectively support all our manufacturing plants in Singapore to supply new product transfer activities as a cost effective, high quality, business and cGMP compliant organization.
  • Drive divisional strategy on site
  • Develop and implement site strategy to achieve the desired business results.

​

Other responsibilities include:

  • Manage all on site Quality functions e.g. quality control, quality assurance, regulatory compliance, provide quality oversight for all GMP activities on site in line with our Quality Management Systems and in compliance to applicable regulatory guidelines.
  • Drive divisional and site strategies on site, build robust quality systems and quality culture.
  • Maintains laboratory areas and manages release of all raw materials, components and manufactured products (bulk drugs, interplant intermediates, dosage forms, and materials for clinical trials) and assures production complies with approved processes, regulatory and corporate requirements.
  • Ensures investigations are performed to resolve production abnormalities and customer complaints.
  • Lead, guide, develop and sustain a highly flexible and motivated business unit team to deliver quality support which are timely, cost effective, cGMP and business compliant.
  • Set direction, strategies, champion innovation, and continuous improvement within the department to take the Quality function to successively higher performance platforms.
  • Lead in the systems development of business, quality, safety, process and personnel recruitment, development, and succession in Quality department
  • Network with internal and external parties to develop robust infrastructure of Quality support systems e.g. corporate directives\initiatives, application of our Quality Management Systems, harmonizing and synergizing best practices etc
  • Facilitate the communications with regulatory agencies to support required compliance and business needs.
  • Partner with site leadership team to develop business and organizational direction, design and execution of management strategies.
  • Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. This can include specific duties involving in maintaining qualified status of equipment by timely application of and reporting exceptions to the GMP systems supporting the qualified state.
  • Supervise and oversee Third Party Contractors, where applicable.
  • Any other tasks as and when assigned by Managing Director and Immediate Manager.

WHAT YOU MUST HAVE

  • Bachelor’s Degree or higher in a related Science, Chemical Engineering or technical field
  • 10+ years relevant experience in a quality assurance and other function (e.g. operations, technical, etc) in pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA
  • Experience of active pharmaceuticals, tablets, sterile and biotech operations and inhalation products preferred.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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 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.


Tell employers what skills you have

FDA
Quality Control
Regulatory Compliance
Quality Assurance
Quality Management Systems
Treatment
GMP
Raw Materials
Clinical Trials
Regulatory Requirements
Laboratory
Agency Agreements
Manufacturing
Biopharmaceuticals
Chemical Engineering
EHS

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