Job Abstract

Job Description

As part of the Global Quality Excellence Team our goal is to deliver site-to-site transfers within Large Molecules on time and within budget to ensure compliant and unconstraint supply of Animal Health vaccines supporting growth of the business.

The Large Molecule Transfer Quality team has the end-to-end responsibility to provide Quality Strategy and Direction, Quality oversight and Quality Support to manufacturing sites and transfer leads as well as portfolio management and governance for all site-to-site transfer activities within the Large Molecule regions. We ensure a standardized approach for the execution of process and test transfers and a close collaboration with our quality organizations at  the manufacturing sites and global functions across regions?. Our team ensures alignment of transfer activities with the Company's strategy by close collaboration with the Network & Strategy Development Office. The role will be based on one of our manufacturing sites in the US to support site-to-site transfers within the US Region.

• With respect to Transfer Quality Compliance Support, the position ensures appropriate design, implementation and maintanence of GMP and Animal Health Quality Standards during transfers:

  • Development and roll-out of Animal Health Quality Manual documents for Quality Transfer related activities

  • Sharing Best Practices of Quality Transfers across impacted Donor and Receiving Large Molecule sites

  • Support of post transfer activities related to implementation to the sites

• With respect to Transfer Quality Operational Support the position ensures support to the sites on Quality activities implementation, mainly, but not limited to:

  • End-to-End oversight of Quality Control test transfer execution and all related transfer activities (Products, Raw materials, Seed Materials, Biomaterials System, storage, qualification, monitoring, stocks, certification documents, specifications …

To fulfill the role the position will:

• Coach and upskill cross functional team members on Quality aspects of transfers, support and ensure collaboration and exchange of best practices across the network

• Build and maintain a strong relationship with relevant stakeholder groups within Quality, Operations and global functions, coordinating and aligning individual Quality activities across the network

• Partner closely with Donor and Receiving LM Sites to ensure Quality activities deployment

• Partner closely with Large Molecule Animal Health Transfer Task Force Team to ensure consistency between Operations and Quality

• Partner with Global Regulatory Affairs to align on requirements and optimization of documentation, if needed

• Partner with other global support functions such as Global Supply chain, BATS, R&D, APS and others, as appropriate

Location, Travel

• The position is based at an Manufacturing US Animal Health Manufacturing site and requires traveling to the Animal Health sites up to 20%.

Skills, Education and Experience

• Bachelor Degree in Chemistry, Pharmacy, Biology or Veterinary or related science discipline

• Strong background in Biological Quality activities

• Minimum 5+ years experience in Pharmaceutical Industry with Biological products, including site based Quality Control role

• Proven knowledge and understanding of GMP and USDA regulations, guidelines and expectations in their application in daily operations

• Proven ability to manage complex projects

• Proven analytical and problem solving and decision-making skills

• Highly flexible and persistent personality

• Strong and effective communicator and negotiator

• Good networker  - Ability to efficiently interact with people and initiate and drive change in complex organizations

• Ability to maintain an overview of multiple (complex) projects and keep focus on key activities

• Broader understanding of a Pharmaceutical company and specially in Quality Control

• Excellent verbal and written communication skills in English  

• Openness to travel abroad

#EBRG

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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