The Sr. QC Laboratory Manager leads and drives technical and operational excellence to achieve a best-in-class Quality Control (QC) operation that fits for an agile and competitive Dietary supplement and OTC CDMO at Aspire. The incumbent is expected to manage the day-to-day operations of the QC Department, stay abreast with best QC practices, collaborate with a multi-disciplinary team on cross-functional projects, and provide strategic and operational inputs to support growth and expansion of the site.
The Sr. QC Laboratory Manager is also expected to evolve with the Quality organization and be a collaborator / change agent for continuous improvement to assure sustainable quality compliance to meet the operational and business needs.
- Be a strategic leader to motivate and lead a team of analysts, and operational personnel to achieve a best-in-class QC laboratory that is forward thinking, agile, efficient and effective to meet business needs.
- Leading and participating in technical discussions / evaluation internally and with clients; bring strategic and tactical plans into attainable actions to achieve on-time delivery of tasks and projects.
- Be the change agent to proactively influence and motivate the QC organization to optimize the planning and operational activities to achieve sustainable quality compliance and meet the business targets of the site.
- Build a strong and collaborative relationship with internal functions / customers (such as Development & Formulation, Project Management, Production, Quality Assurance, Supply Chain, etc.) and external clients, as necessary, to set realistic timelines for QC deliverables.
Operational Excellence and Planning
- Provide technical direction and leadership to ensure the QC & Analytical labs are operating in phase appropriate manner in accordance with GxP (including GLP and data integrity) requirements, company and standards.
- Assure the analytical methods are appropriately developed and validated for its intended purposes;
- Provide technical guidance on and evaluation of internal and external analytical methods for validation and analysis of raw materials, in-process and finished product samples to assure quality compliance (including FDA, Health Canada, USP requirements, etc.).
- Assure all laboratory equipment and systems (including computerized systems) are qualified, validated, secured and maintained for its intended purposes.
- Assure QC personnel are effectively trained and/ or qualified to achieve an agile and effective workforce.
- Exercise technical discretion in the design, execution and interpretation of experiment;
- Perform appropriate data analysis and make scientific recommendations and remedial actions;
- Develop/ write/ revise all applicable technical documents, as necessary/ appropriate (e.g., SOPs, validation/ stability protocols and reports, etc.).
- Proactively develop and implement tools and processes to enhance operational and planning efficiencies.
- Optimize productivity and the utilization of QC resources (people, equipment, systems, and the available space) to meet the operational/ business needs;
- Develop and manage the departmental budgets (e.g., CAPEX, OPEX, development and training, etc.);
- Develop and optimize standard work and work-streams.
- In alignment with Project Management, Operations, and Quality to develop effective and optimal plans to assure on- time delivery of QC deliverables;
- Collaborate with Project Manager in client communications and provide project updates as required;
- Respond to inquires about analytical services for the QC department;
- Review service schedules and Scope of Works to assure the timelines are in alignment with capacity.
- Collaborate with the QC Transformation Specialist to identify gaps and define implementation strategies.
- Establish user-friendly KPI dashboards and provide monthly/ periodic reports on-time for management review.
Quality and Regulatory Compliance
- Adhere to all effective policies and procedures of the site.
- Assure timely completion of all required training prior to performing the associated tasks.
- Assure the QC & Analytical labs are operating in phase appropriate manner for a CDMO and in alignment with GxP (including GLP and data integrity) requirements, company policies and standards.
- Assure all data and records are accurate, documented and maintained effectively and in compliance with Good Documentation Practice and data integrity requirements.
- Assure all the non-conforming test results and QC related deviations are timely investigated in accordance with quality/ regulatory compliance and expectations;
- Appropriate CAPAs are to be timely implemented to prevent recurrences.
- Be the QC lead to support all internal, client and regulatory audits.
- Timely provide appropriate response and CAPA plan to address audit requests and findings.
Environment, Health, Safety and Security (EHSS)
- Adhere to all EHSS programs, rules, and procedures of Aspire.
- Assume personal accountability for individual behaviors related to EHSS activities.
- Have appropriate knowledge and tools (e.g., don applicable PPE) prior to working in designated areas and performing the tasks.
- Complete all required EHSS training and remain current with applicable learning plans.
- Report all injuries within the same shift to the incident occurring; participate or lead the investigation of QC related EHSS incident.
- Report any EHSS hazards or concerns in the workplace in a timely manner.