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Associate Director, GMP Compliance

Merck


Location:
Whitehouse Station, NJ
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
QUA005929
Merck
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Job Details

Job Title: Associate Director, GMP Compliance  - QUA005929

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.
 
Provide compliance leadership and direction to the Site Internal Audit program, and to Sites that manufacture active pharmaceutical ingredients, drug products, biologics, and vaccine products for Merck. Collaborate with site auditors, Regional Compliance Leads, and Site leadership to assess risk, prepare facilities for successful Audits and Health Authority Inspections, to develop any resulting corrective and preventative action plans (CAPA), and to verify CAPA implementation and effectiveness. Specifically:

1. Fully understand regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients, drug products, biologics, and vaccine products and provide leadership and technical direction on application and implementation of these requirements.
2. Using knowledge of regulatory requirements, collaborate with site leadership to prepare facilities for Audits and Heath Authority Inspections. Provide leadership and technical direction during audits and Health Authority Inspections to ensure successful outcomes.
3. Partner with sites and auditors to identify appropriate Corrective and Preventative Action Plan (CAPA) to address any findings identified during audits and Health Authority Inspections. Monitor status of CAPA execution and closure to ensure CAPA are implemented according to plan. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings. Work directly with site management to identify any additional CAPA needed to satisfy deficiencies noted during independent CAPA review.
4. Monitor and analyze the consolidated outcomes of audits and Health Authority Inspections to identify, investigate, and resolve any trends before they impact compliance and supply. Report results to Divisional and Regional Quality Councils.
5. Design, compile, and report risk-based metrics for CAPA, Site audit program effectiveness, and other key compliance/regulatory measures.
6. Provide assessment of audit/inspection observation severity, and review key CAPA responses for adequacy.
7. Author policies, standards, and procedures related to Audits and Health Authority Inspections, ensuring alignment with regulatory requirements.


Qualifications

Education Minimum Requirement:

 
  • A minimum of a Bachelor’s degree in Scientific, Engineering, Computer Science or related area. 

Required Experience and Skills:

  • A minimum of 8 years of Quality, Operational or Technical experience within the Pharmaceutical, Medical Device or Biotechnology Industry. 
  • Demonstrated ability to apply a broad knowledge of Quality Management Systems, international GMPs, and technical knowledge to some or all of the following areas: manufacture/testing of active pharmaceutical ingredients, drug products, biologics, vaccines, or medical devices. 
  • Ability to coach and guide others in Quality/technical related topics. 
  • Ability to compile and deliver meaningful presentations. 
  • Ability to provide business input into the design, implementation, and enhancements to IT systems.


Preferred Experience and Skills:

 
  • Experience in a compliance/Quality related role, performing GMP Audits at the site or Divisional level.
  • Experience as a lead in Health Authority Inspections. 
  • Advanced degree and/or MBA preferred.
  • Demonstrated ability to perform and assess root cause analysis related to observations/investigations 
  • Demonstrated ability to effectively manage multiple projects/tasks simultaneously 
  • Demonstrated ability to make risk based decisions 
  • Demonstrated ability to design and implement tools to report metrics 
  • Demonstrated ability to influence and drive change 
  • Excellent problem solving skills, based on science, facts, and data 
  • Strong demonstrated interpersonal, communication, collaboration and leadership skills 
  • Ability to work in a multi-cultural environment. 
 

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-NJ-Whitehouse Station

Other Locations NA-US-PA-West Point, NA-US-Virginia, NA-US-Pennsylvania, NA-Puerto Rico, NA-US-New Jersey, NA-US-North Carolina

Employee Status Regular

Number Of Openings 4

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