Senior Specialist, Global Quality and Compliance (Animal Health)

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:

cGMP Regulations, Compliance Management, Continuous Improvement, Global Regulatory, Leadership, Quality Management Standards, Quality Standards, Regulatory Compliance

Preferred Skills:

Working Independently

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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The salary range for this role is

$106,200.00 - $167,200.00

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, certificat