The Senior Specialist of Quality & Compliance Management is responsible for driving a consistent culture of compliance within the Regulatory Planning & Publishing (RPP) organization within Global Regulatory and Clinical Safety (GRACS). The incumbent works closely with various stakeholders to drive the development of robust and effective Compliance Management Systems within RPP and ensuring adherence to these systems within daily business processes. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting. Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The responsibilities of the incumbent may include:
In collaboration with the Professional and Organizational Development lead:
- Lead the strategic, organized, systemic approach to training (onboarding/ upskilling) for RPP staff and short-term programs that aligns individual growth with business goals and the employee's development plan, and focuses on creating an agile and flexible workforce.
In collaboration with the Quality and Compliance lead:
- Lead the overall compliance posture of RPP by instituting solid and robust processes and systems that adhere to a regulatory quality and compliance framework.
- Lead all internal and external Compliance audits and Health Authority inspections involving the RPP organization.
- Collaborate with our R&D division's Quality Assurance and GRACS Quality and Compliance on all non-compliance investigations including robust root-cause analysis, ensuring completion of timely and effective corrective and preventative actions (CAPA).
In collaboration with the Process Improvement lead:
- Lead the overall management, direction, coordination, implementation, execution, and completion of RPP projects.
- Manage projects that impact business processes, business development partnerships, and/or information management capabilities throughout the RPP organization. Leverage various methodologies including but not limited to: project management, agile, lean six sigma, design thinking.
- Enhance the infrastructure and processes for a platform from which we can launch comprehensive metrics and reports for project oversight.
- Bachelor's Degree in a relevant field of study
- Minimum of 3 years of regulatory/safety/compliance experience or minimum of 3 years pharmaceutical experience with emphasis on business process and supporting technology.
- Ability to lead, influence and work effectively in a matrix organization
- Ability to communicate effectively, both verbally and written, with others across levels within the organization
- Effective at establishing clear goals and assigning responsibility in a team setting
- Effective team facilitation with ability to establish collaborative team environments
- Detail oriented and drive overall strategy of projects/programs
Desired Experience, Education & Skills:
- Advanced degree preferred (engineering or scientific discipline, MBA)
- Experience in project management methodologies (e.g., PMP, Sigma, Change Management, etc.) and associated toolsets (e.g., MS Project for project planning, MS Excel and/or PowerApps for data analysis and reporting)
- Experience in quality and compliance systems
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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.
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Expected salary range:
$97,680.00 - $153,700.00
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