Global Clinical Operations Global Compliance Leader
7 months ago
**Position Summary**:
The Global Compliance Leader will provide global strategic and operational leadership to the GCO Global Compliance team and is a member of the Global Clinical Operations Leadership Team. Role is responsible for driving activities across GCO to ensure an integrated and comprehensive quality and compliance approach for clinical trials globally and across functions.
The Global Compliance Leader acts as a single point of contact for GCO, ensuring appropriate and timely communication and resolution of significant/critical quality and compliance issues and making recommendations for improvements to relevant senior level stakeholders. In partnership with GD senior stakeholders and R&D Quality, sets and implements compliance strategies to ensure compliance across the clinical trials now and in the future.
Responsible for the development of Compliance staff by supporting the development of Human Resources Planning (HRP) programs including ongoing mentoring, coaching, and training to meet current and future business needs. GCO compliance organization primarily consists of Regional and Country compliance managers and specialists, who are responsible for the day-to-day management of all compliance aspects linked to the clinical trial portfolio in close collaboration with in country trial managers.
**Principal Responsibilities**:
1. Provide operational leadership to Regional Compliance Leaders responsible for implementing and execution of compliance processes in the region in alignment with the R&D Quality strategy and in close collaboration with R&D Quality leaders in the applicable areas. Such processes include, but are not limited to
- setting and achieving region specific Compliance goals and objectives aligned with regional objectives.
- Ensure adequacy of the GCO Quality management system (procedures, training )
- Oversight and harmonisation of QC checks and activities such as On-Site Compliance Monitoring visits, TMF review, etc. in support of QP&S trial oversight and local risk monitoring
- Remediate compliance risk identified through key performance indicators, QC checks and audits/inspections - this may include:
i. being the GCO key SME for any regulatory inspections, ensure readiness and preparation.
ii. Key SME for QSMR and other quality and compliance governances/bodies
iii. Facilitate sharing of lessons learned from audits and inspections.
- Report and escalate significant quality issues along with operational reporting per issue escalation procedures.
2. Set strategic and operational objectives for his/her organization in alignment with the GCO SLT and ensures alignment of these with the overall targets and objectives of the broader GCO organization.
3. Establish and manage budget and resource allocation in the Compliance group. Oversee workload of the staff to ensure optimal utilization of resources.
4. Develop strong working relationships with key business partners and create a culture of cross-functional collaboration across all teams. Works effectively with all DU - DAS & Delivery Operations leaders, GCO Regional Heads, BGIA Risk Management and other GD functions and business support groups as well as R&D Quality, and Clinical Supply Chain QM.
5. Identify high impact improvement opportunities across clinical operations and provide leadership for the development and implementation of innovative business practices and improved business processes.
6. Act as an active member in the GCO SLT, contribute to overall strategy development and implementation for the organization.
7. Build a high performing team through on-going development, performance management and coaching. Take ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process, and foster employee engagement, inclusion, and Credo Behaviors.
**Principal Relationships**:
This role is a member of the Senior Leadership Team (SLT) of Global Clinical Operations and as such is involved in strategic and operational management and decision-making within GCO.
- Internal Global Development relationships: GCO Regional VP’s, Country Heads, DU Teams, BGIA - Business Risk Management
- Internal J&J Relationships: R&D Quality, CSC QM
- External Relationships: including regulatory inspectors, Industry bodies etc Qualifications
**Education**:
A minimum of a Bachelors Degree or equivalent is required. A minimum of 12 years’ experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required. Requires a thorough knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques.
**Related Experience**:
- Experience of the overall drug development process
- Expert knowledg
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