Director, QMS Chapter Owner - Continued Product Assessment & Reporting Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position is critical in Merck’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products with an objective to enable consistently compliant product quality, continuous improvement and effective life cycle management.
Act as a cross-functional leader to Simplify, Standardize & Sustain our QMS, for now and the future. This Director will ensure cross functional alignment and act as change agent for the chapter, including Merck culture and behavior.
Lead development and execution of significant innovation projects driving operational improvements related to all the topics in Chapter 8.
Hold the overall responsibility for MMD Quality Management System Chapter 8 – Continued Product Assessment and Reporting that is critical to ensure our commitments to the patients and compliance of all Merck’s products after released to the markets. Lead the re-design, implementation and sustainment of the global continued product assessment and reporting processes and systems end-to-end, specifically:
- lead a team of functional SMEs who own each topic in the Chapter
- manage the interdependency and collision among the topics within the chapter and between chapters
- develop and implements the strategy for continued product assessment and reporting processes and systems to ensure sustainable compliance of all MMD sites and functions
- provide leadership and technical direction on regulatory requirements for continued product assessment and reporting processes in the GMP/GDP environment
- ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS
Primary activities include, but are not limited to:
1. Develop the strategy and lead the implementation of the redesigned Continued Product Assessment and Reporting Processes chapter across the MMD network and GMP activities in MRL; define the strategy for global requirements to drive harmonization of processes and systems
2. Lead the implementation of requirements related to continued product assessment and reporting processes, including Complaints and AEs, Recalls, Disposition/Reprocess/Rework of Returned Goods, Annual Stability Program, Agency reporting and Product Discontinuation etc.
3. Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS
4. Provide leadership and technical direction on regulatory requirements related to continued product assessment and reporting processes
5. Initiate, where appropriate, and lead communities of practice (CoPs) or center of excellence (CoEs) to drive best practice sharing and continuous improvements across the MMD network
6. Monitor Continued Product Assessment and Reporting Processes chapter health and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance of the systems and processes across the MMD network
7. Influence and advocate Merck’s position on Continued Product Assessment and Reporting related HA expectations through a strong network of external connections and effective external engagement
8. Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements
· Advanced degree in Life Sciences, Engineering or related relevant discipline
· Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management in particular with regards to continued product assessment and reporting processes
· Minimum of 15 years experience in the FDA and/or EU regulated pharmaceutical environment; preferably in an operational quality role and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred
· Ability to accurately interpret and apply regulatory expectations for robust and compliant continued product assessment and reporting processes in a drug, device and biologics manufacturing environment
· Strong project management skills
· Capable of working and communicating effectively with all levels of the organization globally
· Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management
· Proven ability to influence effectively without hierarchical authority multi-functional professionals to drive harmonization and proactive compliance
· Proven ability to effectively initiate and drive change across the MMD network
· Self-motivated with a high degree of ownership and accountability for results
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Job: Regulatory Compliance
Job Title:Dir, Quality Systems & Compliance
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth, NA-US-New Jersey, NA-US-Pennsylvania
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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