Associate Director, Quality USDA

USDA Compliance Subject Matter Expert (SME) Associate Director

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 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 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 :

N / A

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".

Salary :

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 .