Quality Control jobs in United States

• 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.

• 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 process, 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.

• 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).

• Minimum Degree
• Must be from pharmaceutical/biotech/clinical research organisation
• Strong leadership skills, need to oversee a team of 10 people
• Strong in GMP experiences / clinical trial related operation work

All qualified applicants, please click “ APPLY NOW”

Or you may send in your resume to:

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Email : kimlow@recruitexpress.com.sg

Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122

Recruit Express Pte Ltd Company Reg. No. 199601303W | EA LICENCE Number: 99C4599