Associate Director, Quality USDA at Merck Sharp & Dohme Corp. /Netherlands

De Soto, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

199100.0

Posted On

22 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Animal Health Care, Audit Inspections, cGMP Regulations, GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices, Inspection Readiness, Quality Auditing, Quality Management, Quality Management System Auditing, Quality Management Systems, Quality Standards, USDA Regulations

Industry

Pharmaceutical Manufacturing

Description

Job Description The USDA Compliance Subject Matter Expert (SME) – Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead. The responsibility of this position is across all Animal Health operating units; however, the position will focus on US Quality activities related to governance by the USDA. The role will require collaboration with manufacturing sites, contractors, and suppliers. Primary Responsibilities: Provide Subject Mater Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL). Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents. Develop a risk-based approach to prioritize USDA compliance requirements for our manufacturing sites. Understand and provide guidance on Ingredients of Animal Origin issues. Ensure any audits or sites assessments are conducted to assess compliance with applicable USDA regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions. Evaluate audit findings and ensure timely identification/ escalation of potential critical observations and compliance gaps observed during audits. Develop and maintain a strong training program for USDA requirements to increase knowledge and skills development and ability to detect and communicate GxP compliance concerns. Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements. Participate in industry groups (e.g. Animal Health Institute) that assess and influence standards and trends within Animal Health. Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program’s ability to detect compliance to current and evolving expectations. Ensure timely identification and escalation of potential critical observations and compliance gaps Assist during USDA audits. Oversee quality and compliance activities within assigned area of focus. Comply with all of our company's corporate guidelines and policies. Education Requirement: Bachelors degree in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required. Required Experience and Skills: 10 years experience and expert knowledge of USDA governance requirements. Knowledge of international GMPs/ requirements of multiple regulatory agencies Strong technical background Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position. Accountable for actions, drives results, and learns from mistakes Demonstrates good judgment and logical thought processes in collecting and synthesizing relevant data and information to make independent and timely decisions Communicates, influences, and escalates issues and decisions, as appropriate Communicates effectively up and down, at all levels of the organization Demonstrates tolerance for ambiguity Able to travel up to 20% of the time Preferred Experience and Skills: Experience working for a health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/regulatory role or Site Quality Head at a USDA governed site Required Skills: Animal Health Care, Audit Inspections, cGMP Regulations, GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management, Quality Management System Auditing, Quality Management Systems (QMS), Quality Standards, USDA Regulations 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 EEOC GINA Supplement 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 U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 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, 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 11/24/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R370452

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Responsibilities

The Associate Director will ensure compliance with USDA standards across all Animal Health operating units, focusing on US Quality activities. This role involves collaboration with manufacturing sites, contractors, and suppliers to maintain adherence to regulatory requirements.