Job Overview:

The Compliance and Regulatory Manager/Director plays a critical role in ensuring the smooth operation and adherence to regulatory standards at our In Vivo Primate Quarantine and Breeding Facility. This position is responsible for overseeing compliance with guidelines from organizations such as AALAC, FDA, OLAW, and internal Standard Operating Procedures (SOPs). The role involves maintaining and updating SOPs, conducting quality control assessments, leading inspections, and managing interactions with regulatory agencies and sponsor representatives.

SOP Management: Review, update, and maintain SOPs to ensure compliance with industry standards and regulations, addressing emerging requirements as needed.

Quality Control: Monitor and enforce adherence to SOPs through regular quality control assessments, rectifying deviations as necessary.

Inspections: Conduct comprehensive quarterly and semi-annual inspections to assess compliance with regulatory standards, reporting findings and corrective actions.

Regulatory Agency Interactions: Serve as the primary point of contact for regulatory agency representatives during site inspections, coordinating and leading tours.

Site Inspections: Continually conduct site inspections to ensure ongoing compliance with guidelines, promptly addressing non-compliance issues.

IACUC Oversight: Lead and manage the Internal Animal Care and Use Committee (IACUC) to ensure ethical and regulatory compliance in animal care and research.

Protocol Review: Oversee the review and approval of research protocols involving animal subjects to ensure ethical and regulatory compliance.

Training and Education: Develop and implement training programs for staff, researchers, and IACUC members on animal care, ethics, and regulatory compliance.

Compliance Monitoring: Monitor and assess ongoing compliance with approved protocols and ethical standards, conducting inspections as necessary.

Collaboration: Work closely with research teams, veterinarians, and facility staff to ensure ethical and compliant animal research practices.

Responsibilities:

The key responsibilities for this position include but are not limited to:

- SOP Management:

- Review, update, and maintain facility Standard Operating Procedures (SOPs) to ensure compliance with industry standards and regulations.

- Develop and implement new SOPs as needed to address emerging compliance requirements.

- Quality Control:

- Monitor and enforce adherence to SOPs through regular quality control assessments.

- Identify and rectify any deviations from established procedures.

Inspections:

- Conduct quarterly and semi-annual full inspections of the facility to assess compliance with regulatory standards.

- Prepare comprehensive reports detailing findings and corrective actions.

- Regulatory Agency Interactions:

- Serve as the primary point of contact for regulatory agency representatives during site inspections.

- Coordinate and lead regulatory agency representatives and sponsor representatives on tours of the facility.

- Site Inspections:

- Continually conduct site inspections to ensure ongoing compliance with all relevant guidelines.

- Address any non-compliance issues promptly and efficiently.

- Collaborate with research and laboratory teams to ensure that animal care and research activities align with regulatory standards.

- Provide guidance and training to facility staff regarding compliance and regulatory matters.

- Stay updated on industry trends, changes in regulations, and best practices to implement necessary adjustments.

- Assist in the development and management of the facility's budget related to compliance activities.

- Participate in the preparation and submission of reports required by regulatory agencies and sponsors.

- Act as a liaison between the facility and external regulatory bodies, ensuring effective communication and cooperation.

- Investigate and resolve any compliance-related incidents or concerns.

- Conduct risk assessments and recommend strategies to mitigate compliance risks.

IACUC Oversight: Lead and manage the Internal Animal Care and Use Committee (IACUC) to ensure compliance with ethical and regulatory standards in the care and use of animals in research.

- Protocol Review: Oversee the review and approval process for research protocols involving animal subjects, ensuring that they meet ethical and regulatory requirements.

- Committee Meetings: Organize and facilitate regular IACUC meetings, ensuring that minutes are recorded and maintained in accordance with regulatory guidelines.

- Training and Education: Develop and implement training programs for researchers, laboratory staff, and IACUC members regarding animal care, ethical considerations, and regulatory compliance.

- Compliance Monitoring: Monitor and assess ongoing compliance with approved protocols and ethical standards, conducting random or scheduled inspections as necessary.

- Recordkeeping: Maintain comprehensive records of all IACUC activities, including protocol approvals, reviews, and compliance assessments.

- Reporting: Prepare and submit required reports to regulatory agencies, as well

as internal reports to management and the research community.

- Investigations: Conduct investigations into any animal welfare concerns, protocol deviations, or non-compliance issues, and implement corrective actions.

- Policy Development: Collaborate with the Compliance and Regulatory Manager/Director to develop and update institutional policies and procedures related to animal care and use.

- Collaboration: Work closely with researchers, veterinarians, and facility staff to ensure that animal research is conducted in an ethical and compliant manner.

- External Audits: Prepare for and facilitate external audits by regulatory agencies or accreditation bodies, providing necessary documentation and assistance during inspections.

Qualifications:

- Bachelor's degree in a related field (e.g., Biology, Animal Science, Regulatory Affairs).

- Minimum 4 years of experience in compliance and regulatory management within a similar laboratory animal facility or biomedical research environment.

- Knowledge of relevant regulations, including AALAC, FDA, OLAW, and Good Laboratory Practices (GLP).

- Strong attention to detail and analytical skills.

- Excellent communication and leadership abilities.