Descrição
Janssen Research & Development, LLC, a Johnson & Johnson Company, is hiring an Associate Director, Internal Animal Welfare & Regulatory Compliance Lead to be located in Spring House, PA, La Jolla, CA, or Beerse, Belgium.
At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com
The Internal Animal Welfare & Regulatory Compliance Lead manages animal welfare & regulatory compliance activities within the US based and European IVS Animal Care Programs in alignment with Global IVS, Johnson & Johnson Innovative Medicine, and Johnson & Johnson standards related to the humane use of animals in research and preclinical safety sciences.
Key Responsibilities:
- Partner with local Institutional Animal Care and Use Committees (IACUC), Ethical Committees and Animal Welfare Bodies and the Global Institutional Official to ensure that the institution meets or exceeds all internal, local, national, and regional laws, policies, regulations and accreditation standards governing the humane care and use of animals in research and testing
- Provide oversight of audits and system evaluations, operations, and/or processes for compliance with appropriate work instructions/standard operating procedures and regulatory compliance requirements, including partnering with all stakeholders on key activities and standards
- Provide oversight to the site IACUCs, ethical committees and animal welfare bodies
- Guide best practices and innovative solutions that address all aspects of animal welfare and regulatory compliance in the animal care programs including global harmonization across Janssen’s international sites
- Coordinate the tracking and reporting on observed quality and compliance trends within the animal care & welfare programs, including oversight of the development and maintenance of work instructions/standard operating procedures and proposed changes to current practices and policies as appropriate
- Participate in internal assessments, regulatory inspections, and accreditation site visits as needed, including oversight of the maintenance of the AAALAC Program Descriptions and applicable regulatory documentation
- Supervise formal and informal training and consultation, including orientations, training, and development and implementation of standard operating processes and procedures related to the use of animals
- Advise the Global Institutional Official (IO), including facilitating communication between the Global IO, Designated/Attending Veterinarians, researchers, and others stakeholders across the region
- Assist in global animal welfare and regulatory compliance activities as assigned
- Serve as a transparent and effective champion for the 3Rs
- Coordinate maintenance of records to align with applicable local, state, federal regulations, applicable animal welfare accreditation standards, and internal compliance regulations
IVS Essential Personnel Statement:
- This is an essential personnel role. Essential Personnel are defined as the staff who are required to report to their designated work location, to ensure the operation of essential functions or departments during an emergency, as determined by Janssen, or when the business has suspended operations. There are some individuals who may be required to perform essential services remotely and those individuals will be identified in advance and notified by their supervisors, but in most cases Essential Personnel are required to be on-site during an emergency or suspension of operations.
Qualificações
Education:
- Bachelors degree in related field is required
- Masters in quality assurance and/or other advanced degrees (DVM, VMD, Ph.D.) is preferred
- Strong working knowledge of applicable US and European legislative and country level regulations applicable animal welfare guidelines, and AAALAC standards is required
Experience and Skills:
Required:
- Minimum of five (5) years of experience in animal-based research is required
- Strong analytical, problem-solving, and decision-making skills is required
- Excellent oral and written communication skills are required
- Regularly read, understand, and follow-through on all correspondence is required
- Work under time constraints with minimal direction of day-to-day responsibilities is required
- Excellent organization skills, including scheduling, timely follow-up, and attention to detail is required
- Regularly read, understand, verify accuracy, and document various written protocols, including Animal Care and Use Protocols, Standard Operating Procedures, work instructions, etc. is required
- Working with external regulatory agencies and accreditation groups is required
- Some “off-core business hours” meeting participation and work is required
- Completing all annual training requirements is required
- Perform all work per appropriate safety standards is required
- Stay ahead of current trends and practices in field of expertise by completing required continuing education is required
- Ability to wear all Personal Protective Equipment required to perform work tasks is required
- Applicable vaccinations for entry and work within specific laboratory and vivarium spaces is required
- Performs other duties as assigned is required
- This role may require up to 25% travel
Preferred:
- Certified Professional in IACUC Administration (CPIA) or related Quality Assurance certifications are highly preferred
- Understanding of the overall process of drug discovery and development is preferred
- Major biotech/pharma experience preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com