External Site Quality Lead

Date: Feb 11, 2019

Location: Arecibo, PR

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Requisition ID: QUA008540

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

 

The position corresponds to a team leader responsible for implementing the Merck Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply drug products to Merck.


The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and drug delivery systems; executed under the direction or on behalf of the External Quality Assurance Director, and with particular focus on the deviation management quality system, including coordination of significant investigations and regulatory agency notifications.


These activities include assuring that products are manufactured from approved processes in conformance to all applicable regulatory requirements and Company policies. The incumbent will exercise a leadership role in monitoring and maintaining contracted third-party compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.


The incumbent may also ensure the quality performance of the Contract Manufacturer through direct oversight, support and technical advice, counseling to the third-party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third-party selection, GMP Due Diligence, and establishing of Quality Agreements.


The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the Contract Manufacturer; and maintains compliance with the Quality Agreements between the parties.


The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.

 

The person has to visit our Puerto Rico External Manufacturing offices approximately 25% of the time.This position does not include relocation assistance.

Qualifications

Requirements:

 

  • Bachelor's Degree in Science (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or related disciplines).
  • A minimum of five (5) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to deviation management, as well as significant investigation and Fact Finding coordination.
  • Experience in Quality Agreement development and cross-functional teamwork.
  • Familiarity with Field Alert Reporting.
  • Proficiency in Spanish and English, in oral and written.
  • Willing to travel up to 25% of the time outside and within Puerto Rico.

 

Preferred skills and experience:

  • Strong demonstrated communication skills.
  • Prior experience managing Manufacturing 3rd Party relationships.
  • Demonstrated personal networking and relationship building skills.
  • Conversant on domestic and foreign regulations and compendia governing manufacturing operations.
  • Contractual and financial awareness.
  • Experience in Lean project implementation. 

 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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:

 

            EEOC Poster

            EEOC GINA Supplement 

          OFCCP EEO Supplement

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


Job: Qual Assurce - 3rd Party Manuf
Other Locations: Carolina, Metro, PR; Las Piedras, East, PR; Barceloneta, North West, PR
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials:
Company Trade Name: Merck

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