Associate Director, Quality USDA

Hispanic Alliance for Career Enhancement; Delaware; Hybrid; USD 126,000 - 200,000; Full time

Job summary

A leading compliance consulting firm is seeking a USDA Compliance Subject Matter Expert (SME) - Associate Director to ensure that manufacturing sites adhere to USDA regulations. This role requires 10 years of experience with USDA governance and a Bachelor's degree in a relevant scientific discipline. The successful candidate will have a strong technical background and will develop training programs while maintaining compliance with regulatory standards. Hybrid work options are available.

Benefits

Comprehensive benefits package

Annual bonus eligibility

Flexible work arrangements

Qualifications

• 10 years of experience and expert knowledge of USDA governance requirements.
• Strong technical background with effective communication skills.
• Accountability for actions and ability to drive results.

Responsibilities

• Ensure compliance with USDA regulations and conduct audits.
• Maintain a strong training program for USDA requirements.
• Develop and maintain global Quality Management System documents.

Skills

Animal Health Care

Audit Inspections

cGMP Regulations

GMP Auditing

GMP Compliance

Quality Management

Quality Standards

Education

Bachelor’s degree in microbiology, biochemistry, biology, or similar

Job description

Overview

The USDA Compliance Subject Matter Expert (SME) - Associate Director reports to the Animal Health Global Quality Compliance and Technical Lead. The role affects all Animal Health operating units, with a focus on US Quality activities related to governance by the USDA. The position requires collaboration with manufacturing sites, contractors, and suppliers.

Primary Responsibilities

• Provide Subject Matter 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 site 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.
• 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 company corporate guidelines and policies.

Education Requirement

• Bachelor’s degree in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required.

Required Experience and Skills

• 10 years of experience and expert knowledge of USDA governance requirements.
• Knowledge of international GMPs/requirements of multiple regulatory agencies.
• Strong technical background.
• Experience listening to and gathering a range of perspectives and with the ability to develop solutions and champion a position.
• Accountability for actions, drives results, and learns from mistakes.
• Good judgment and logical thought processes in collecting and synthesizing relevant data to make independent and timely decisions.
• Effective communication, ability to influence, and escalate issues and decisions as appropriate.
• Ability to communicate effectively up and down the organization.
• 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:

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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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid schedule of three total days on-site per week, Monday–Thursday (days may vary by site), with Friday as a remote-working day unless business-critical tasks require on-site presence. This model does not apply to field-based roles, facility/manufacturing/research-based positions located at a Company site, roles under a collective-bargaining agreement (unless the agreement provides for hybrid work), or roles where remote work is not feasible. This guidance does not apply to roles designated as remote.

Compensation and Benefits

The salary range for this role is $126,500.00 - $199,100.00. The actual offer will depend on factors including education, qualifications, certifications, experience, skills, location, and business needs. The successful candidate will be eligible for annual bonus and long-term incentives, if applicable. We offer a comprehensive benefits package (medical, dental, vision, retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days). More information is available at the company compensation and benefits page.

Application Process and Location Details

You can apply for this role through the company careers site. The application deadline for this position is stated on the posting.

Location-Specific Considerations

San Francisco residents: We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents: We will consider qualified applicants, including those with criminal histories, in a manner consistent with applicable laws and the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.

Additional Information

Search Firm Representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms. CVs/resumes submitted without a valid written agreement will be the property of the company. No fee will be paid in such cases. 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: 11/11/2025. A job posting is effective until 11:59:59 PM on the day BEFORE the listed end date. Requisition ID: R370452.