Job Details
Merck & Co, Inc
Veterinary Device Specialist, Animal Health | External Manufacturing Quality
Job Description
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Animal Health External Manufacturing Quality (AH-EMQ) is an organization of approximately 45 professionals with the common objective of compliant, competitive, and quality oversight of goods & services from leading suppliers and partners that deliver a competitive advantage to our Company.
AH-EMQ Device team is responsible for the direct oversight of the total quality performance and operations of Contract Manufacturing Organizations(CMOs, including Service Centers) of veterinary devices through direct support, guidance, and counselling to the sites’ Quality Unit to ensure the CMOs comply with applicable Current Good Manufacturing Practices regulations and other pertinent legal requirements and Animal Health standards.
As part of the Contract Manufacturing Organizations (CMO) team for Animal Health, the Specialist contributes to and drives strategic projects to ensure high quality and cost competitive Contract Manufacturers for our Company Animal Health products. The Specialist supports the business case development and execution of opportunities within the category to meet stakeholder and customer needs across all species teams and the global business.
This role will report to the Devices CMO Lead within the Animal Health External Manufacturing Quality team and contribute directly to enabling high value cost savings opportunities and consolidation of multiple products with key strategic partners around the world.
The primary purpose of the position is to participate as the quality representative in the restructuring of the CMOs used by Animal Health for manufacturing of veterinary devices. The successful candidate will also ensure that veterinary devices, as defined in Animal Health standards, comply to applicable international and local GMP requirements and the requirements of Animal Health Quality Manual or other internal agreed standards.
Additional Responsibilities
Ensures device CMOs comply with minimum requirements per MAH applicable Quality Standards and procedures
Keeps management informed on the status of operations and when challenges, opportunities and/or issues arise
Ensures that the needed Quality Agreements or change notifications are correctly negotiated and kept up to date and consistent with the Quality elements in the Commercial Agreement. Participates in the review of the Quality elements in the Commercial Agreement
Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement
Conversant with the technology and regulatory framework within which the CMO operates
Acts as AH Quality Operations point of contact between the CMO and the internal AH personnel in terms of the quality requirements for implementation of changes at current CMOs and for selection and evaluation of new CMOs
Assures Quality requirements on Change Proposals submitted by the CMO conform to all requirements
Supports AH audit plans and the effective execution of subsequent remediation by the partner
Supports training and coaching to initiate quality improvements within the CMO operations where necessary
Reviews all Deviation investigations submitted by the CMOs and supports further investigation where necessary
Maintains Quality metrics
Minimum Requirement
Bachelor degree or equivalent preferably in Engineering or Science fields
Experience or Skills
Required
Knowledge of Quality Systems and Quality Assurance including knowledge of GMPs
Demonstrated experience managing change controls, deviations and CAPAs
Strategic and ethical interpersonal, communication, collaboration, negotiation, analytical, and project management skills
Demonstrated strong leadership, problem solving, and team building skills/experience, including ability to relate to or demonstrate awareness of diverse cultural backgrounds and experiences
Highly organized with attention to detail and accuracy with the ability to exercise initiative, tact, and independent judgment
High degree of flexibility and adaptability to deal with ambiguous and dynamic situation
Principled and strong verbal and writing skills
Confidence with Microsoft Office software, especially with managing and analyzing significant datasets in Excel or similar
Ability to manage multiple simultaneous and complex projects requiring frequent communication, organization, time management, and problem-solving skills
Confidence in decision making skills and ability to work independently
Preferred
Prior internship, co-op, or work experience in the pharmaceutical or healthcare industry
Enterprise Resource Planning software, such as SAP
Ability to translate strategic vision into tactical plans and manage the change required to implement
Manufacturing or customer-service industry
Participation and membership in a team-based organization or activity
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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US and Puerto Rico Residents Only:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Remote Work, Telecommuting, Work WeekShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Number of Openings:
1Requisition ID:R146187