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Director GMP Compliance Remediation & Support

Merck


Location:
West Point, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
QUA005937
Merck
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Job Details

Job Title: Director GMP Compliance Remediation & Support  - QUA005937

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.
 

Position Overview – Basic Functions & Responsibility  Essential function(s) includes, but is not limited to:

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 Compliance Remediation and Support department.  This Director will ensure cross functional alignment and act as change agent for Director, Multi Products Compliance and Remediation Support. 

Lead development and execution of significant innovation projects driving operational improvements related to all the topics supporting multi products– Compliance, Remediation and Support.

Support CAPA and inspection readiness processes that are critical to ensure a standardized and sustained QMS. Support alignment for those chapters related to quality/compliance and data integrity including alignments from Global QMS that may apply to inspection readiness, inspection support and remediation.

Ensure robust processes are in place and in use to maintain CAPA management and remediation support.  This includes authoring documents, data entry of metrics and CAPA supporting compliance, remediation, and support. 

Lead during efforts to support inspection remediation and CAPA management processes, demonstrated experience as a lead during Board of Health related inspections.

Primary Activities       Primary activities include, but are not limited to:

  1. Develop the strategy and lead the implementation of the CAPA management and remediation across the MMD network, GMP and AH activities including MRL; define the strategy for global requirements to drive harmonization of processes and systems
  2. Lead the implementation of QMS requirements related to CAPA Management and Compliance Remediation Support.
  3. Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignments related to GMP and DI requirements.
  4. Provide leadership and technical direction on regulatory GMP/GDP requirements
  5. Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the MMD network
  6. Develop 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 across the MMD network
  7. Influence and advocate Merck’s position on CRS processes  related to 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
  9. Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain the Merck CRS and associated documents
  10. Lead development and execution of significant innovation projects driving operational improvements; this will require cross-functional support within the Global CRS team and Global QA and External Affairs.

 



Qualifications

Education Minimum Requirement: 

  • Bachelor's degree in Life Sciences, Engineering or related relevant discipline.  Advanced degree preferred.

Required Experience and Skills: 

  • Thorough understanding of regulatory requirements for drugs, devices, biologics, including quality risk management and knowledge management
  • Minimum of 15 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred
  • Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS 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 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:
 
           
           


Job Qual Assurance & Ops Generic

Primary Location NA-US-PA-West Point

Other Locations NA-US-NJ-Whitehouse Station West, NA-United States

Employee Status Regular

Number Of Openings 2

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