Compliance Analyst role at Leve Saúde ensuring adherence to regulations in the health sector. Responsibilities include audits, policy management, and due diligence processes.
About the role
- Associate Director of Compliance responsible for ensuring compliance with USDA regulations in animal health manufacturing. Collaborating with various stakeholders across manufacturing sites and maintaining quality management systems.
Responsibilities
- Provide Subject Matter Expertise to 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).
- 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 sites 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 program’s 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 company's corporate guidelines and policies.
Requirements
- 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
- 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
- Demonstrates tolerance for ambiguity
- Able to travel up to 30% of the time (domestic and international travel)
Benefits
- 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
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Governance, Risk & Compliance Specialist at Quilter providing oversight on governance, risk, and compliance activities, strengthening Quilter Invest’s risk management culture across the organization.
Regulatory Specialist responsible for contributions in public consultations and regulatory studies. Engaging with institutional relations and ensuring adherence to energy regulations in Brazil.
Working Student supporting regulatory and compliance efforts at Paymenttools' e - money institution. Collaborating on risk management and compliance projects in a hybrid role based in Cologne.
Senior Consultant Regulatory Affairs participating in pharmaceutical projects focused on market access and regulatory compliance. Joining Deloitte's sector regulation team based in Madrid.
Trade Compliance Officer managing stakeholder compliance with UK and US export laws. Contributing to trade policies and documentation for international imports and exports in a hybrid role.
Expert HSE Compliance role focused on environmental regulations and safety in energy production at EniBioch4in. Overseeing compliance, audits, and promoting HSE culture across facilities.
Junior Regulatory Reporting Operations Specialist analyzing vast trade reporting data and ensuring regulatory reporting quality at SEB. Collaborating with teams to resolve reporting issues for regulatory compliance.
Risk & Compliance Advisory Practice Lead at Netwealth providing risk and compliance advice across investment and product governance. Leading advisory teams while ensuring regulatory compliance and risk management standards.
Director Compliance role at Manulife managing the Complaints & Regulatory Investigations team. Overseeing investigations and ensuring compliance with regulatory standards.