(South) Senior Clinical Trial Operations Manager (Must Have Pharma / Clinical Trial / Biotech / GMP Exp!) Up 8K #HJC

Roles & Responsibilities

WORKING HOURS :

• 8am - 5pm / 9am - 6pm
• Fully on Site

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

Strong in GMP experiences / clinical trial related operation work

TELE me at @jacechooo or WA me at https : / / wa.me / +6582976283 NOW!

Interested candidates please submit your resume to jacechoo@recruitexpress.com.sg

Jace Choo Oi Kei

Personnel EA License No. : R1875164

Recruit Express Pte Ltd (EA Licence No. : 99C4599)

Tell employers what skills you have

Coaching

Mentoring

Leadership

Regulatory Compliance

Clinical Research

Team Development

GMP

Business Strategy

Packaging

Prevention

Employee Relations

Performance Management

Audit

Incident Management

EHS