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.
United States - FL - FL - Gainesville
June 6, 2024
Run your own profitable business Work for yourself, see the country and set your own schedule. As a Panther owner-operator, youll run under our operating authority while maintaining full control of your business as an independent contract carrier. Youll also gain access to significant cost saving...
United States - FL - FL - Port Charlotte
June 28, 2024
Ultrasound Technologist Millennium Physician Group Full TimeFort Myers, FL • Are you a skilled and passionate X-Ray Tech looking for an exciting opportunity in the beautiful Fort Myers, FL area? If you're seeking a position that offers a perfect work-life balance and a great team atmosphere, then...
HealthTrust Workforce Solutions HCA
United States - FL - FL - Margate
June 28, 2024
HealthTrust Workforce Solutions HCA is seeking a travel nurse RN CVOR for a travel nursing job in Margate, Florida. & Requirements • Specialty: CVOR • Discipline: RN • Start Date: 07/22/2024 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours, days • Employment Type: Travel • Perks: 7:00AM -...
United States - FL - FL - Bradenton
June 28, 2024
TRUCK DRIVING JOBS: WE ARE HIRING DRIVERS! We're a Certified Top Pay Carrier and • the top 50 percent of our drivers • average$90,518 per year. STRONGER TOGETHER • It s part of the American fabric. Good people getting a job done. Customers facing deadlines. Drivers delivering safely and on time. And...
United States - FL - FL - Gainesville
June 28, 2024
Triage Staffing is seeking a travel Speech Language Pathologist for a travel job in Gainesville, Florida. & Requirements • Specialty: Speech Language Pathologist • Discipline: Therapy • Start Date: ASAP • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, days • Employment Type: Travel Travel...
United States - FL - FL - Seminole
May 27, 2024
Location: 8380 SEMINOLE BLVD, Seminole, FL Want to be a Pizza Hut Team Member, Your Gig, Your Schedule, Your Opportunity, Great Perks, Same Day Pay! • That's right, working at Pizza Hut as a Team Member is about creating your own opportunity and having fun while making new friends. You can be the...
HealthTrust Workforce Solutions
United States - FL - FL - Panama City
June 9, 2024
Grow Your Career with HealthTrust • Locum Tenens Hospital-based • At HealthTrust, we believe that healthcare is not defined by the four walls in which it is practiced. Its defined by its people. We pride ourselves on crafting opportunities that expand skill sets, broaden career horizons,...
United States - FL - FL - Lake Mary
June 25, 2024
*Located in The Sanford area. • One of Florida's most respected counties is looking for Correction Officers for immediate hire. This is a permanent, full time, long term career opportunity in the criminal justice field. Pay starts at $20/hr for no corrections experience, and will pay up to...
United States - FL - FL - Pembroke Pines
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Panama City
June 28, 2024
Talent4Health is seeking a Social Work Licensed Clinical Social Worker for a travel job in Panama City, Florida. & Requirements • Specialty: Licensed Clinical Social Worker • Discipline: Social Work • Start Date: 07/22/2024 • Duration: 13 weeks • 40 hours per week • Shift: 8 hours, days • Employment...
United States - FL - FL - Bradenton
June 28, 2024
Healthcare Support is seeking a travel CT Technologist for a travel job in Bradenton, Florida. & Requirements • Specialty: CT Technologist • Discipline: Allied Health Professional • Start Date: 07/29/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, nights • Employment Type: Travel •...
United States - FL - FL - Fort Lauderdale
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Santa Rosa Beach
May 22, 2024
Earn big and work on your own time and terms as a Grubhub delivery partner! Grubhub is looking for drivers and bikers like you to hit road quick and start delivering from restaurants, convenience stores, and more. Looking for a flexible way to earn extra cash? Grubhub is the gig for you. • Why...
United States - FL - FL - Key Biscayne
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Arcadia
June 28, 2024
Aureus Medical Group - Therapy is seeking a travel Physical Therapist for a travel job in Arcadia, Florida. & Requirements • Specialty: Physical Therapist • Discipline: Therapy • Start Date: ASAP • Duration: 14 weeks • 40 hours per week • Shift: 8 hours • Employment Type: Travel Estimated payment...
United States - FL - FL - Margate
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Hialeah
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Largo
May 27, 2024
Location: 8380 SEMINOLE BLVD, Seminole, FL Want to be a Pizza Hut Team Member, Your Gig, Your Schedule, Your Opportunity, Great Perks, Same Day Pay! • That's right, working at Pizza Hut as a Team Member is about creating your own opportunity and having fun while making new friends. You can be the...
United States - FL - FL - Sanford
June 25, 2024
*Located in The Sanford area. • One of Florida's most respected counties is looking for Correction Officers for immediate hire. This is a permanent, full time, long term career opportunity in the criminal justice field. Pay starts at $20/hr for no corrections experience, and will pay up to...
United States - FL - FL - Miami Gardens
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
HealthTrust Workforce Solutions HCA
United States - FL - FL - Ocala
June 28, 2024
HealthTrust Workforce Solutions HCA is seeking a travel nurse RN CVICU for a travel nursing job in Ocala, Florida. & Requirements • Specialty: CVICU • Discipline: RN • Start Date: 07/29/2024 • Duration: 13 weeks • 36 hours per week • Shift: 12 hours, nights • Employment Type: Travel ACLS, BLS, NIH...
United States - FL - FL - Port Charlotte
June 28, 2024
Scheduler - Millennium Home Care • Location: Port Charlotte, FL 33980 • About Us: • Millennium Home Care, an affiliate of Millennium Healthcare LLC, is dedicated to • providing exceptional home care services to our clients. We prioritize compassionate • care and continuous improvement to ensure the...
United States - FL - FL - Miami
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Venice
June 28, 2024
Medical AssistantFull TimeVenice, FL New Grads Welcome! • As a Medical Assistant/LPN, you will be responsible for the Patient Experience of every patient who walks into your office by assisting in the examination and treatment of patients under the direction of the Physician, ARNP or PA. •...
HealthTrust Workforce Solutions
United States - FL - FL - Sebring
June 9, 2024
Grow Your Career with HealthTrust • Locum Tenens Hospital-based • At HealthTrust, we believe that healthcare is not defined by the four walls in which it is practiced. Its defined by its people. We pride ourselves on crafting opportunities that expand skill sets, broaden career horizons,...
United States - FL - FL - Coral Springs
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...
United States - FL - FL - Hallandale
May 30, 2024
Overview • Summary: • The Inside Sales Representative is responsible for preparing sales information and maintain quality customer and employee relations. • Principal Duties and Responsibilities: Sales: • Prepare quotes for customers providing information on pricing in accordance with established...