Associate Director Quality
MSD
Summary
The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project according to our quality systems, including Training, Documentation, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with regulatory requirements.
Job description
The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. This is an individual contributor role and partners with the operations and technical operations leaders to ensure that the facility will be designed and qualified in alignment with approved processes and comply with all applicable regulatory and internal requirements.
Essential Functions and Responsibilities
- Executing quality system functions relating to GMP compliance, and coordinating and directing multi-department teams to support ongoing maintenance and enhancements of the quality system(s)
- Ensuring personnel operate within established policies and procedures of our company and in compliance with cGMPs and all applicable government regulations
- Ensuring that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
- Serving on local and site governance committees, Technical/Operations Reviews, and regulatory forums, as well as participating and driving strategic initiatives
- Acquiring and maintaining technical process knowledge to support critical thinking and decision making
- Reviewing and approving compliance documents such as deviations, corrective / preventive actions, commitments, and change requests
- Primary Quality lead for Capital Project support in design, qualification and approval phase
Requirements
- Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR Master's degree in Science, Engineering, or another technical field with six (6) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
- Minimum two (2) concurrent years' experience managing direct reports
- Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.