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.
Essential functions include but are not limited to: working independently across functional disciplines, with guidance from the vendor quality lead, to ensure the implementation and execution of the MRL vendor strategic quality plan. Communicates the strategy across MRL functional areas and assess/identifies areas of risk. Through the execution of the strategic quality plan, ensures vendors (covering Animal Welfare, preclinical, development, clinical, regulatory and PV) meet internal standards and regulatory requirements. Collaborates within MRL QA and with partnering areas to ensure execution of tasks necessary to achieve quality goals. Assignments are complex and require detailed understanding of regulations, vendor oversight methods and processes to minimize and mitigate risks.
Primary activities include but are not limited to :
- Provide input to, assist in the integration of and verify execution of a vendor quality strategy to ensure that MRL vendors meet MRL standards and regulatory requirements. Ensure that MRL functional areas understand the strategy and implement the necessary processes and controls to achieve the strategy.
- Provide input to the development of and ensure the implementation of tools and techniques to assess, report and mitigate risk and issues with vendors contracted across MRL functional areas and partners. Work with other MRL QA groups to ensure that vendors understand and meet minimum requirements set forth in the strategy.
- Under the guidance of the vendor quality lead, work with vendors and MRL functional areas to ensure implementation of quality plans, KPI's and KQI's, where appropriate. Assist with the integration of quality considerations into the vendor selection process.
- Independently verify execution of the vendor quality strategy, support departmental operational activities utilizing advanced competencies, knowledge and judgment; participates in new vendor assessments/qualifications and represents MRL QA on governance committees, as appropriate
- Act as a source of knowledge for vendor quality, risk assessment and regulatory requirements. Build effective working relationships with key vendor quality representatives.
- Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures. May assist with the preparation or review of relevant SOPs or policies relevant to MRL QA or partnering MRL organizations.
- Collaborate effectively across areas within MRL QA and MRL functional areas to help achieve quality goals and understanding of and application of appropriate regulations.
- Contribute to, or assist with educational and training materials and sessions to further develop competencies or understanding across MRL QA and partnering MRL areas, where applicable.
- Bachelor's degree or equivalent experience is required, advanced degree or training a plus
- Minimum of 5 years QA experience or relevant experience in quality management, with a focus in the relevant area of responsibility
- Understanding of and experience with risk assessment tools
- Prior people leadership experience desired, i.e. project teams, direct reports, etc. with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
- Proven ability to function autonomously in a matrix model and in a team environment
- Proven ability to think creatively and to execute and manage strategic plans
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 email@example.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.
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