Executive Director, US Regional Quality Lead - Large Molecules, Animal Health

Job Description

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.

The Executive Director, US Regional Quality Lead - Large Molecules, Animal Health reports to the Associate Vice President, Global Large Molecules Quality-Animal Health and provides directions to the US Quality teams responsible for testing, release and compliance of Large Molecules Products manufactured at our company's US sites. The position is responsible for setting a vision, developing the strategy, and driving its execution within the US sites and in alignment with the strategy of the Global Large Molecules Quality Organization.

Primary Responsibilities:

• Leads the Site Quality Heads of the US sites located at Elkhorn- NE; Desoto, MO; Worthington, MN; Ames, IA; Millsboro, DE; Omaha, NE

• Partners closely with regional lead of the Large Molecules Operations to ensure alignment on the strategy and deliverables.

• Works with the Site Heads to ensure the quality activities are properly conducted to meet the supply needs for our customers within an appropriate level of the applicable USDA, GMP or other applicable regulations.

• Ensures development and implementation of the standardize practices within the US sites under the USDA Establishment license.

• Fosters strong collaborations among the US sites as well as the close collaborations with the other global LMQ sites.

• Actively assesses the performances of their teams, develops, and coaches’ talents and ensures succession planning within the organization through mentoring and development programs.

• Leads, promotes, integrates, and monitors the implementation and maintenance of Safety, Health and Environmental (EHS) management systems within the sites’ Quality organizations and promotes collaboration with the SLT in enhancing the site safety.

• Promotes a culture of continuous improvement and target zero within a Quality Management Systems framework towards a compliant, effective, and efficient organization in the US Region with right resources in Place.

• Effectively communicates and escalates issues through the Management Notification Process to ensure that any product quality, compliance, and supply issue is communicated properly and in a timely manner to align with the Global Quality Leadership on the recommended actions including our notifications to Health Authorities.

• Defines organizational or process gaps, develop strategies and implements changes as required to ensure the enhancement of the efficiencies on a continuous basis. Engages in the discussions required to develop and execute the corrective actions within the US sites and ensures the effectiveness of the actions.

• Analyzes the events and deviations together with the sites, assesses the risks and provides recommendations on the actions and steps forwards as relates to the mitigation of the risks.

• Ensures that the Quality Organization provides timely and effective supports for the product supply chain to ensure delivery of high Quality and compliant products to customers in time.

• Partners with other Global functions/ SMEs from the company's Network e.g., from Global Quality, Technical Support R&D, Global Regulatory Affairs to ensure effective collaboration and communication and obtain these resources for supporting the Sites’ activities as necessary. Attend in relevant steering meetings or working groups as relevant.

• Ensures effective communications with relevant regulatory authorities, especially with USDA, but also other authorities as relevant e.g., EU GMP, Turkish and Russian autohides.

• Collaborates with the Global Quality and Operations Teams leading the MPS activities, considering people development on MPS skill sets and methodologies. Identifying resource needs and/or technical knowledge gaps to acquire institutionalization status in MPS tools (tier, kata…)

• Partners closely with the US Operations Lead as well as Site Heads in fostering the Quality culture at the sites.

Minimum Education Requirements:

• Bachelor's Degree in an appropriate Scientific, Management or Animal Health. Master's degree preferred......Preferred fields of study include Biology, Animal Science, Biochemistry, and Microbiology.

Required Experience and Skills:

• Fifteen (15) years of work experiences in a bio-pharmaceutical and/or vaccines (Preferably in Animal Health) in a global Quality or Manufacturing Leadership role.

• Strong knowledge of Health Authority regulations specially the CVB-USDA and EU GMP is required.

• Solid Experiences with continuous improvement/MPS, Management of changes, principles of Hoshin Kanri, Six Sigma and lean practices.

• Ability to effectively apply Quality Risk Management principles in ambiguous situations

• Ability to work effectively in a diverse global environment with colleagues at all levels of the organization.

• Advanced proficiency in written and verbal communications in English.

• Demonstrated leadership, influence, and people management skills, including interactions outside of formal reporting lines in a matrixed organization.

• The role requires at least 50% travel

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, 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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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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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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Requisition ID:R215612