Executive Director, Quality Management Systems Chapter Owner – Technology Transfer & Job

Employer
Merck
Location
Whitehouse Station West, NJ, US
Posted
February 28 2017
Discipline
Other
Organization Type
Pharma
Executive Director, Quality Management Systems Chapter Owner – Technology Transfer & Commercialization-QUA005624

Description

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 Executive 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 5.

Hold the overall responsibility for MMD Quality Management System Chapter 5 – Technology Transfer and Commercialization that is critical to all our new product launch and execution of network strategy. Leads the re-design, implementation and sustainment of the global technology transfer, all three stages of validation and commercialization processes and systems end-to-end, specifically:

- leads a team of functional SMEs who own each topic in the Chapter

- manages the interdependency and collision among the topics within the chapter and between chapters

- develops and implements the strategy for the technology transfer and commercialization processes and systems to ensure sustainable compliance of all MMD sites and functions

- provides leadership and technical direction on regulatory requirements for technology transfer and commercialization processes and associated support systems

- ensures quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS

Primary Activities:

- Develop the strategy and lead the implementation of the redesigned technology transfer and commercialization chapter across the MMD network and GMP activities in MRL; define the strategy for global requirements to drive harmonization of processes and systems

- Serves on QMS governance body to ensure appropriate design and sustainment

- Lead the implementation of technology transfer, validation and commercialization requirements

- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS

- Provide leadership and technical direction on regulatory requirements for technology transfer and commercialization processes and systems in the GMP/GDP environment

- Initiate, where appropriate, and lead communities of practice (CoPs) or center of excellence (CoEs) to drive best practice sharing and continuous improvements for technology transfer and commercialization across the MMD network 3

- Monitor the QMS Technology Transfer and Commercialization 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 compliance with technology transfer and commercialization requirements and performance across the MMD network

- Influence and advocate Merck’s position on technology transfer and commercialization related to HA expectations through a strong network of external connections and effective external engagement

- Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements

Qualifications

Education Requirement:

- Advanced degree in Life Sciences, Engineering or related relevant discipline

Required:

- Thorough understanding of regulatory requirements for technology transfer, validation and commercialization processes of drugs, devices, biologics, including quality risk management

- Minimum of 20 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably with operational experience in leading technology transfer and commercialization activities and/or experience in related areas in Global functions; experience in vaccines, biologics, devices and API manufacturing requirements preferred

- Ability to accurately interpret and apply regulatory expectations for robust and compliant technology transfer and commercialization operations in a drug, device and biologics 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 staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Quality GMP Related

Job Title:Exec. Dir, Quality Systems & Compliance

Primary Location: NA-US-NJ-Whitehouse Station West

Other Locations: NA-US-NJ-Kenilworth, NA-US-PA-West Point

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck