Oversees the global compliance function and related processes within the range of laboratory, clinical, manufacturing and distribution operations; Provides direction to Compliance staff, to drive compliance activities to ensure an inspection readiness status in the cGMP and GxP environments, to ensuring compliance to policies and procedures for adherence with company standards and applicable local, state, federal, and international regulations governing drug products, and medical devices.
Key Responsibilities/Essential Functions
- Actively engages with the organization and directs quality improvements, evaluating multiple perspectives. Creates new processes and procedure aimed at continuous improvements and efficiency.
- Conducts ongoing surveillance of world-wide regulations, agency guidance documents, industry standards, new technologies and internal needs. Works with functional owners to ensure updates to procedures and policies to comply with the ever-changing regulatory environment.
- Oversees the support activities for all regulatory audit processes relating to GxP including, but not limited to, FDA, MHRA, EMA and Health Canada. Provides corporate training on inspection readiness and best practices.
- Oversees and executes the self- inspectionaudit program for all GxP areas to assure compliance with policies procedures and regulatory requirements. Works with functional owners to drive corrective actions and ensure the effectiveness of responses. Creates metrics to improve the performance of the self-inspection process.
- Manages the Annual Product Quality Reports (APQR) to ensure accurate and timely completion of required documents.
- Oversees the LMI Product Complaint process, aiding in the investigation of product complaints, identifying product complaint trends and ensuring timely closure of product complaints and appropriate escalation (i.e. field alerts). Collaborating with Pharmacovigilance (PV) to ensure Adverse Event / Complaint management are managed in a timely manner.
- Manages the LMI Field Alert and Product Recall processes including the development and maintenance of procedures associated with these processes.
- Responds timely to compliance concerns and oversees problem resolution to completion. Manages multiple compliance projects, realigning resources and priorities to meet challenging timeframes
- Assures research and development work activities are compliant with all appropriate regulatory requirements (GLP/GCP). Supports GCP / GLP activities by planning and effectively managing the implementation of audits, both internal to research and development clinical work and external to investigators.
- Manages the range of performance management processes for compliance team members. Contribute to budgetary processes, including efficiency opportunities, in collaboration with management team
- Acts as liaison with local, state, federal, and global regulatory agency inspections
- Maintains current knowledge of global regulatory agency trends and drives implementation of related improvements throughout Operations and R&D work groups. Maintains current expertise in all related external regulatory requirements, technology, and internal systems, processes and procedures
- Proactively seeks to affect change to provide an inspection readiness state and reduce the number of observations identified during audits/inspections conducted
- Oversees the creation and maintenance of compliance metrics, development of trend data of audit/inspection observations and communication of results expediently to applicable groups
- Collaborate with the Manufacturing Quality organizational and serves as a technical/regulatory resource for R&D and
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards
- Actively demonstrates the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.
- * In the case of absence the reports to Manager above or a peer incumbent will function as a backup for this position.
- BS/BA degree in a related medical, science or business discipline or equivalent training and formal experience; Advanced degreepreferred.
- 15+ years?experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical industry or equivalent.
- Functional expertise in pharmaceutical regulatory compliance (cGMP) is required; Strong knowledge of compliance in clinical compliance and GMP is required.
- Must complete relevant certifications, tests, and or exams required for compliance with internal standards and regulatory agencies within established timeline for position
- Routine and, or extensive overnight travelrequired based on business need