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.
Merck is seeking a Director Biologics/Therapeutic Proteins Analytics Quality. The individual selected will report to the associate Vice President Biologics/Therapeutic Proteins/Sterile Quality Strategy. The incumbent develops and executes the strategy for all Quality and GMP compliance related activities relating to the analytical testing and release of biologics and therapeutic protein drug substance across the line of business to ensure compliance with all applicable regulations and specifications. The scope of this roles encompasses the internal Merck network as well the external manufacturing and testing network. Additionally, the responsibilities are closely integrated with biologics and vaccines development quality activities in Merck Research Laboratories.
1. Provide strategic decision making and executive sponsorship of Quality initiatives in the area of Biologics and therapeutic Proteins Analytical Testing
2. Collaborate with the Quality team, the Biologics/Therapeutic Proteins/Sterile Line of Business (Bio/TP/Sterile LOB) and the Technology function to proactively develop and execute a coherent, proactive Quality Strategy in Biologics/TP/Sterile Analytical Testing.
3. Serves as an executive sponsor of strategic work streams associated with the above said Strategy.
4. Quality business partner for Bio/TP/Sterile LOB and the Technology function
5. Quality decision maker in setting of analytical testing profiles and specifications for Biologics and Therapeutic Proteins. Is the Quality representative on specification setting committees.
6. Ensure that applicable and upcoming regulations and Global Quality requirements are embedded in Biologics and Therapeutic Proteins analytical testing, in partnership with the senior leadership of the Bio/TP/Sterile LOB .
7. Collaborate closely with Merck Site Quality Leaders, as well as the Biologics Quality Operations External Manufacturing organization (BQOEM).
8. Provide sponsorship of initiatives associated with new technical developments like real time testing and release, online monitoring of manufacturing processes and critical process parameters, rapid microbiological testing and others, across all Lines of Business (LOB) and not limited to the Bio/TP/Sterile LOB.
9. Support and contributes to internal and external Quality and compliance forums to identify and evaluate emerging trends for continuous improvement. For example:
Surveillance of applicable regulations, guidance, and regulatory intelligence to update Quality Management
System and develop actions plans for the LOB, where required
Attendance and participation in internal Quality f orums and cross-divisional (MMD and MRL) teams
Participation in industry working groups
Enhancement of line of business (LOB) compliance performance through coordination and collaboration
with LOB and site leaders. Interacts with senior leaders in other LOBs to identify and address emerging
and/or common issues across LOBs.
10. Serves in the role of coach and mentor to develop future skills and competencies in the LOB and functional areas. Ensures strong succession planning and bench strength to support the future needs of the business. Actively sponsors and monitors performance to promote a diverse workforce. This is a critical attribute of this leadership position.
Bachelor's degree in an appropriate scientific or engineering field of study is required; an advanced degree is preferred. Preferred fields of study include Biology, Biotechnology, Biochemistry, Chemistry, Engineering and Microbiology.
Strong analytical skills are important, and solid foundation in aseptic processing is essential.
An MBA or other business degree, in addition to the required science or engineering education, is preferred.
10 years of leadership experience directly related to Quality Control and/or Quality Assurance is required.
5 years of significant leadership experience directly related to Biologics and Sterile Quality Control and Quality Assurance is required.
Strong understanding of cGMPs, including FDA, EMEA, Health Canada, TGA, and PMDA is essential.
Additional critical attributes include: a) strong compliance mindset, b) excellent communication skills, c) ability to work collaboratively in team settings, across divisions, and within matrix organizations to achieve objectives, and d) strong commitment to diversity and employee development.
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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.