Summary
- The Senior Manager, Operations will head a team responsible for producing clinical trial supplies.
- This includes pre-production and planning, label production, and manufacturing and packaging teams.
- This role will provide leadership and direction to deliver on business strategy, meet client requirements, achieve regulatory standards, ensure on-time delivery, quality, and efficiency targets, and establish safe working practices within a GMP environment.
- The position holder will be a key member of the Site Leadership Team.
SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES
- Leadership and Management: Provide direct leadership to a team involved in the production of clinical trial supplies, including pre-production/planning, label production, and secondary packaging.
- Resource Allocation: Using S&OP data and production plans, manage resource allocation, planning and risk mitigation to ensure the team is appropriately staffed to meet workloads.
- Risk Mitigation: Work with internal stakeholders to resolve workflow or technical issues that could disrupt operational demands.
- Technical Review: Responsible for the timely technical review of batch records to meet production timelines.
- Stakeholder Partnership: Maintain close partnerships with all stakeholder groups (e.g., PM, QA, Supply Chain) to ensure site delivery goals are achieved.
- Operational Performance Management: Manage Key Performance Indicators (KPls) for operational areas, participate in the target-setting prncess, and prepare, maintain, and present monthly KPls.
- Continuous Improvement: Develop continuous improvement (Cl) strategies to advance operations, including implementing processes that minimize production costs and waste while maximizing production output.
- Regulatory Compliance: Ensure operational areas under your responsibility within the facility are in an audit-ready state and that facility EHS regulations are adhered to for accident/loss prevention.
- Standard Practices: Develop or revise standard operational and working practices for operational areas.
- Audit Support: Represent operations and support QA with regulatory audits and client audits/visits, including providing audit responses and CAPAs related to operational processes.
- Quality Incident Management: Support the team with the investigation of quality incidents, including the implementation of CAPAs to minimise the chance of recurrence.
- Metrics and Reporting: Tracking and reporting of metrics to senior management and operations personnel to identify and drive performance improvements.
- Financial and Non-Financial Objectives: Support the Site Head with business line financial and non. financial objectives, including the monthly M&P forecast, annual budget, and operating plans.
- System Knowledge: Basic working knowledge of department systems such as Clinicopia, JDE, SupplyFlex, and other platforms used by Operations.
Line Management Responsibilities
- Training and Compliance: Ensure team members are trained and following standard operating procedures.
- Staffing and Development: Conduct regular one-on-one meetings with direct reports to provide personalized support, guidance and development.
- Team Development: Hold routine operational team meetings to foster open communication and collaboration across the department.
- Goal Implementation: Implement department goals and objectives in line with top-down company/division goals
- Coaching and Mentoring: Provide ongoing coaching, mentoring, and development for direct reports, leading a highly motivated, efficient, and effective team.
- Employee Relations: Manage employee relations, including performance evaluations, new employee hiring, disciplinary notices, employee termination, rewards, and recognition according to company guidelines and performance requirements
- Administrative Approvals: Manage team administration (e.g. review and approve team holiday requests and expenses.)
Requirement :
- Min Degree
- Must from pharmaceutical/ biotech/ clinical research organisation
- Strong leadership skills, need to oversee a team of 10 pax
- Strong in GMP experiences / clinical trial related operation work
All qualified applicants, please click APPLY NOW
Or you may send in your resume to:
Whatsapp: https://wa.me/+6589530688
Email :
Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122
Recruit Express Pte Ltd Company Reg. No. 199601303W | EA LICENCE Number: 99C4599
