Quality Compliance Manager overseeing compliance implementation and project management in medical device industry. Strong experience in Quality Management Systems and cross - functional collaboration is required.
About the role
- Director of Global R&D Compliance at BeOne providing strategic compliance guidance in biopharmaceuticals. Leading efforts to sustain compliance culture and integrity in a rapidly evolving healthcare environment.
Responsibilities
- Serve as a trusted, strategic advisor to Global R&D stakeholders, providing real-time, practical compliance guidance.
- Participate in key meetings to offer risk-based insights on clinical, scientific, and research activities.
- Deliver tailored compliance training and communications to ensure alignment with internal policies, industry standards, and regulatory expectations.
- Provide compliance risk assessment, education, and oversight for Global R&D and Global Medical Affairs functions.
- Oversee the development, implementation, and maintenance of Global R&D compliance policies and related SOPs.
- Design, deliver, and evaluate engaging, role-based compliance training for R&D stakeholders.
- Conduct live and remote monitoring of R&D activities and provide timely feedback to stakeholders.
- Ensure interactions with HCPs, HCOs, study subjects, and patients comply with BeOne policies, SOPs, and industry standards.
Requirements
- Bachelor’s degree required; advanced degree (JD, MBA, MPH, or related scientific field) strongly preferred.
- 10+ years of relevant compliance, legal, or R&D experience in the biopharmaceutical or life sciences industry.
- Strong understanding of global clinical development, research operations, and global regulatory frameworks.
- Prior experience advising Global R&D or Medical Affairs functions preferred.
- Demonstrated ability to serve as a strategic, solutions-oriented business partner while maintaining independence and objectivity.
- Exceptional communication skills, with ability to influence, coach, and guide stakeholders at all levels.
- Strong analytical, problem-solving, and risk assessment capabilities.
- Ability to work autonomously and manage competing priorities in a dynamic environment.
- High degree of integrity, professionalism, and sound judgment consistent with OIG and DOJ expectations for effective compliance programs.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Discretionary equity awards
- Employee Stock Purchase Plan
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Food Technologist for Regulatory team at IRCA Group managing compliance of raw materials and labels. Ensuring regulatory adherence across EU and APAC markets with a focus on food safety.
Compliance Analyst contributing to Pacific Life's mission in Consumer Affairs, reviewing and resolving complaints. Collaborating with management and internal departments for effective complaint handling.
Trade Compliance Analyst managing customs and compliance data for Canadian operations. Ensuring adherence to trade regulations and supporting internal audits and CBSA requests from the Toro Company.
Trade Compliance Analyst ensuring compliance with USMCA regulations through product origin analyses and audits. Supporting trade agreement monitoring and advising internal stakeholders in compliance matters.
Compliance Manager overseeing safety and environmental quality in multiple healthcare facilities. Leading regulatory compliance and safety procedures with continuous readiness for accreditation.
Senior Manager overseeing regulatory asset management and project delivery in a global biopharma company. Leading cross - functional collaboration to ensure oversight and compliance with regulatory strategies.
Ethics & Compliance Summer Intern supporting daily tasks and departmental projects in compliance and auditing. Gaining hands - on experience in risk management and cross - functional collaboration.
Compliance Manager executing risk - based compliance reviews and surveillance within investment management firm. Supporting compliance activities across Americas with emphasis on testing and reporting.
Senior Compliance Engineer supporting EMC testing and compliance for new product development at Stryker Medical. Collaborating with teams to ensure regulatory compliance throughout product lifecycle.