Associate Director, Compliance

Associate Director Of Compliance

The Associate Director of Compliance will report to the Large Molecule Regional Quality Lead, Americas. The responsibility of this position is across all Animal Health operating units and requires extensive collaboration with manufacturing sites, contractors, and suppliers. Primary responsibilities include :

Subject Matter Expertise : 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).

Global Quality Management System : 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.

Risk-Based Approach : Develop a risk-based approach to prioritize USDA compliance requirements for our manufacturing sites.

Audits and Compliance : Ensure any audits or site assessments are conducted to assess compliance with applicable USDA regulations / guidelines, customer requirements, SOPs and project specific guidelines / instructions.

Training Program : 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.

Regulatory Trends : 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.

Industry Participation : Participate in industry groups (e.g. Animal Health Institute) that assess and influence standards and trends within Animal Health.

Stakeholder Updates : 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.

Audit Leadership : Lead high-risk or complex audits.

Quality and Compliance Activities : Oversee quality and compliance activities within assigned area of focus.

Corporate Compliance : Comply with all of our company's corporate guidelines and policies.

Education requirement :

B.S., in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 8 years of experience OR M.S. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 5 years of experience OR Ph.D. in microbiology, biochemistry, biology, biological engineering, pharmacology, chemistry, chemical engineering, or similar scientific discipline required and 2 years of experience.

Required experience and skills :

Expert knowledge of international GMPs / requirements of multiple regulatory agencies Strong technical background within quality compliance 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 30% of the time (domestic and international travel)

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, or other GMP / regulatory role

Required skills :

Quality Assurance Compliance, Quality Compliance, Quality Management Standards, Quality Management Systems (QMS), Regulatory Compliance, USDA Regulations

Preferred skills :

Salary range for this role is $139,600.00 - $219,700.00. 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 .