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Job Description

Join our team as the Sr. Specialist, Global Quality and Compliance! You will lead regulatory intelligence processes (QMS regulations management and compendial) for our global Animal Health manufacturing sites and provide expert guidance and support. The Sr. Specialist will contribute to continuous improvement to our processes, evaluate domestic and international regulatory updates and ensure compliance.

Responsibilities Includes:

• Serve as a Global Reg Intelligence coordinator (lead) for QMS Regulations Management Process and support the Compendial Review Process.
• Lead the QMS Regulation Management process and main liaison with Clarivate (service provider) including administrative activities to ensure Global Animal Health Manufacturing (GAHM) compliance state.
• Responsible for evaluating regulation updates for several countries and issuing administrative tasks to ensure sites compliance state
• Serve as Back-up for Animal Health Quality Manual (AHQM) Coordinator

• Provide training and coaching to site personnel as needed to support the processes.
• Other duties as assigned.

Education Requirements:

• Minimum Bachelor's degree in science, engineering, or related areas of study.

Required experience and skills:

• 8+ years' experience in Animal Health biological vaccine and /or pharma manufacturing, quality control, regulatory affairs and/or quality assurance
• Knowledgeable of GMP regulations and requirements
• Knowledgeable of or willing to learn international regulatory requirements
• Detail oriented, self-motivated, displays critical thinking and able to work independently
• Has experience leading-through-influence, remotely and in-person, to meet desired outcomes.
• Displays continuous improvement mindset

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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