Associate director, External Manufacturing Quality Job - United States
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.
There are 2 primary aspects of this position
1. External Manufacturing Oversight
The primary purpose of the position is to ensure that all products supplied to Merck Animal Health from North America based Contract Manufacturers for API and Veterinary Products are manufactured, packaged, analyzed and distributed in conformance to company and regulatory guidelines and meet both internal and external customer demands. The incumbent is accountable to ensure that all products released for sale and/or physician samples (where applicable) have been manufactured in accordance with the Product License, Product Quality Specifications and Good Manufacturing Practices (GMP).
The incumbent is responsible for the direct oversight of total quality performance and operations of such Third Party Operations through direct support and technical advice, guidance, counselling to the site Quality Operations Manager or Director as well as on-site supervision. The incumbent exercises a leadership role in monitoring and maintaining the Third Party compliance with Current Good Manufacturing Practices regulations and other pertinent legal requirements.
- Reports to the Executive Director, Quality Assurance for External Manufacturing (Animal Health) and is a member of the Quality External Manufacturing team. Receives guidance and direction when necessary; discharges all responsibilities independently. Keeps the Executive Director informed on the status of operations and when challenges, opportunities and/or issues arise.
- Conducts Quality due diligence assessments, as necessary, for pre-approval considerations of new partners according to company standard for that partner
- Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable agencies or regulations) and in accordance with the Quality elements of the Commercial Agreement, the Quality Agreement; ensures the Quality Agreement are kept up to date and ensures review of the Quality elements in the Commercial Agreement
- Acts as Merck-AH Quality Operations point of contact to North America third parties and as the Quality liaison between the external partner and the internal company personnel. Coordinates Merck Animal Health audit plans and effective execution of subsequent remediation by the partner;
- Determines if additional testing is required on findings with questionable results
- Assures Quality requirements on Change Proposals submitted by the partners and/or Merck and conformance to all requirements on the
- Change Proposals are met before approving release of batches made under the changes,
- Assures guidance is provided to the partner in the preparation of Quality Systems, procedures and guidelines as applicable; ensures robust systems for supplier and CMO management oversight exist
- Enforces established validation requirements to assure that the process is under control and in compliance with registered procedures. Makes on-site decisions as to the quality of the product/process and ability of site to perform quality validation and testing,
- Ensures that ongoing validation programs of third party operations for in-line products are implemented on a timely basis, according to Intervet Standards and local regulations.
- Ensures proactive support in training and coaching to initiate quality improvements within the partners’ Operations
- Effectively contributes to cross-functional investigation and project teams.
- Review stability data and initiate change proposals in support of MCSR (Minor changes and Stability Report) filings to FDA in the United States, where required.
2. Santiago Quality Leadership
The remote management of the Quality team in Santiago specifically for review, packaging and release for all imported products.
This activity is planned to be contracted out in future and consequently will then be managed according to the External Manufacturing principles as outlined above. In the short term there is an ongoing requirement to remotely manage the team of 5 Quality staff located in Santiago, Mexico.
- QC analysis for customer technical support
- Batch review for all products imported into Mexico
- Batch release for all products imported into Mexico
- To maintain the existing quality systems in accordance with local requirements and the
- MMD Animal Health Quality Manual
- Coordination of Batch review for imported products
- Product release for local market products.
- To assure the availability of approved specifications (Packaging materials and products according local requirements)
- Manage the team based on MMD requirements (e.g. HtR, myCareer, etc.)
- Preparation and Management of expense and headcount budget
- Responsible for hosting relevant site audits (Regulators and customers)
- Bachelor degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
- Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
- Must have Spanish language capability
- Must have training in conducting Audits (example ISO 9001)
- Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management;
- Must have the ability to influence management of complex manufacturing operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMPs and regulatory issues
- Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organizational complexity and ambiguity
- Must have exemplary people/team leadership experience, including leading and motivating teams. Experienced in establishing performance metrics and holding people accountable 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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Quality Lab Related
Job Title:Assoc. Dir, Quality Control
Primary Location: NA-US-NJ-Madison
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Medical, Microbiology, Manager, Industrial, Healthcare, Science, Management, Manufacturing