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 :

• Provide subject matter expertise to ensure our companys 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.
• 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 programs ability to detect compliance to current and evolving expectations.
• Ensure timely identification and escalation of potential critical observations and compliance gaps.
• Lead high-risk or complex audits.
• Oversee quality and compliance activities within assigned area of focus.
• Comply with all of our companys 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 :

N / A

Relocation : No

VISA Sponsorship : No

Travel Requirements : 25%

Flexible Work Arrangements : Remote

Shift : 1st - Day

Valid Driving License : Yes

Hazardous Material(s) : N / A

Requisition ID : R370268