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 aspires to revolutionize the way biologics / sterile are manufactured. As we secure our future as a leading biopharmaceutical organization, Merck is making a firm commitment to embrace leading edge technology, systems, process and culture to enable us to ensure the highest quality product for patients, reduce time to approval and maximize yield in biologics / sterile production. As part of this commitment we are creating a new internal organization with a specific focus on researching and implementing new practices and technology for the benefit of our global manufacturing network.
In this role you will lead the organization to implement systems, in process checking processes, analytical data capabilities, track and trace logistics to find opportunities to reveal underlying root causes of issues in production. We look for opportunities to lever "vaccines mindset", disposable production technologies, electronic data capture (Trackwise / SAP) and develop more capabilities from our external manufacturing partners.
We search for someone who is a strategist, true innovator and hands on implementer. You should be able to find solutions to problems never before solved and can change the mindset / culture of sites to embrace your proposed changes.
The Director Biologics / Therapeutic Proteins Analytics Quality, reports to the Executive Director 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 our Research division.
- Providing strategic decision making and executive sponsorship of Quality initiatives in the area of Biologics and therapeutic Proteins Analytical Testing
- Collaborates 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.
- Serves as an executive sponsor of strategic work streams associated with the above said Strategy.
- Is a key Quality business partner for Bio/TP/Sterile LOB and the Technology function.
- Is the key Quality decision maker in setting of analytical testing profiles and specifications for Biologics and Therapeutic Proteins. Is the Quality representative on specification setting committees.
- Ensures 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.
- Collaborates closely with Merck Site Quality Leaders, as well as the Biologics Quality Operations External Manufacturing organization (BQOEM).
- Provides 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.
- Supports and contributes to internal and external Quality and compliance forums to identify and evaluate emerging trends for continuous improvement. For example:
a. Surveillance of applicable regulations, guidance, and regulatory intelligence to update Quality Management System and develop actions plans for the LOB, where required
b. Attendance and participation in internal Quality forums and cross-divisional (Manufacturing Division and Research Lab) teams
c. Participation in industry working groups
d. Enhancement of 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.
- 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; an advanced degree is preferred. Preferred fields of study include Biology, Biotechnology, Biochemistry, Chemistry, Engineering and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is beneficial.
- Strong analytical skills are important, and solid foundation in aseptic processing is essential.
- At least 10 years of leadership experience directly related to Quality Control and/or Quality Assurance is required including at least 5 years of significant leadership experience directly related to Biologics and Sterile Quality Control and Quality Assurance.
- Strong understanding of cGMP, including FDA, EMEA, Health Canada, TGA, and PMDA is essential.
Additional critical attributes include:
- strong compliance mindset,
- excellent communication skills,
- ability to work collaboratively in team settings, across divisions, and within matrix organizations to achieve objectives,
- 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 email@example.com .
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Visa sponsorship in not available for this position
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
For more information about personal rights under Equal Employment Opportunity please visit www.merck.com .