(South) Senior Clinical Trial Operations Manager (Must Have Pharma/ Clinical Trial/ Biotech/ GM[...]

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization in Singapore is seeking a Senior Manager, Operations to lead a team responsible for producing clinical trial supplies. The ideal candidate will have strong leadership skills, GMP experience, and a degree in a relevant field. Responsibilities include managing resources, ensuring regulatory compliance, and fostering team development in a GMP environment. This role is fully on-site and is vital to achieving business and operational goals.

Qualifications

• Min Degree from a pharmaceutical/biotech/clinical research organization.
• Strong leadership skills with experience in overseeing teams.
• Proven track record in GMP and clinical trial operations.

Responsibilities

• Lead a team responsible for producing clinical trial supplies.
• Manage resource allocation and risk mitigation.
• Ensure compliance with regulatory and operational standards.

Skills

Leadership skills

GMP experience

Team management

Education

Min Degree

Tools

Clinicopia

JDE

SupplyFlex

Job description

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/[phone] NOW!
Interested candidates please submit your resume to [e-mail]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)