The company's GxP Compliance function is tasked with providing independent assurance services designed to enhance scientific innovation with effective risk management. The GxP Compliance team partners with the business to strengthen the commitment to compliance by advising cross-functional teams through the Strategy subfunction, identifying and mitigating risk through the Audit subfunction, and leading distribution and proactive compliance through the Operations subfunction.
The GxP Strategy Senior Manager is responsible for supporting the development, execution, and management of the Good Pharmacovigilance Practices (GVP) Compliance program at the company. This role advises internal and external key stakeholders on GVP matters and assesses compliance with international regulations/guidelines, corporate policies, and standard operating procedures. This individual provides support for regulatory inspections for assigned products and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues.
Compliance strategy and execution
Collaborate with stakeholders on quality review of PV and REMS documents, including SOPs, Pharmacovigilance Site Master File (PSMF) audit content, and REMS material; for PSMF content, provide routine updates and ensure on-demand readiness and compliance with the legal requirements in the EU/EEA
Work with internal and client group leaders to proactively identify, communicate/escalate, and mitigate material compliance risk
Influence decision makers and utilize sound problem-solving skills to recommend options for implementation of compliant and effective solutions
Provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans
Assist with tracking GVP Compliance audit trends and group metrics
Act as a key GVP compliance team member on regulatory inspection readiness teams and oversee the development and tracking of GVP regulatory commitments
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to the company policies and practices to maintain proactive compliance
Maintain expert level knowledge of compliance requirements and industry trends, including relevant modalities such as gene therapy, small molecule applications, and enzyme replacement therapies (ERTs)
Participate in the development and/or enhancement of GVP Strategy and corporate GVP/GxP Compliance business processes, procedures, and best practices
Act as a subject matter expert by providing GxP Compliance advice and counsel to internal stakeholders, including training and updates for applicable regulations and guidelines
Inform stakeholders regarding compliance trends and changes
Participate in the development and/or enhancement of corporate GxP Compliance processes, procedures, and best practices
Actively represent the Compliance organization in applicable forums and provide update
Provide input to the Audit team on risk-based audit planning/scheduling and appropriateness of corrective actions for audits of internal and external PV entities
Represent Compliance during issue management and escalation scenarios. Communicate critical information regarding significant quality or patient safety risk to senior/executive management and key stakeholders
The Senior Manager will have a sound foundation of experience in GVP subject matter. This position will contribute to and make an impact on the department and the cross-functional process.
Creates a team/working environment that encourages open dialogue and questioning of status quo, assumptions and the exploration of innovative and novel solutions
Obtains appropriate key stakeholder and/or decision maker buy-in to any recommended solution even in contentious scenarios
Demonstrates an understanding of organizational structure, key decision-making processes and governance and communication channels
Demonstrates the ability to garner support from peers and positively influence outcomes, decisions, or group direction
Inspires, motivates and empowers employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
Demonstrates an ability and eagerness to actively contribute to team efforts in a positive and constructive manner, including by taking on a leadership role within own area of work when needed
Adapts communication style, message and delivery method and medium to audience; knows when to ask for guidance on complex or difficult messages
Able to facilitate small and large meetings efficiently and effectively across functions, promoting collaboration, meeting stakeholder needs, and accomplishing meeting objectives
Develops and communicates short- and long-term priorities through an assessment of future trends and current strategy
Acts as subject matter expert in both the understanding and interpretation of global regulations and guidance
BA/BS degree with a focus on life sciences or a related scientific or technical discipline
8+ years drug safety, clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS
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