Manager, Quality Control Raw Materials

Job purpose

The main responsibility of this role is to provide leadership to the team of analysts and laboratory technicians through employee development and performance management, establishing a Culture of Quality as per the Health Canada and FDA regulations.

This position is targeted to ensure efficient performance of the overall QC Laboratory by employment of the cross-team process improvements, execution of the periodic productivity assessments, robustness checks and work flow optimization initiatives.  Also this role is focused on development of the plan & implementation of the One Taro key deliverables for the QC department on quality & compliance, operational excellence through service level & productivity; enhancement of business and electronic systems as well as strong personnel empowerment and development.

In addition, this position is holding a responsibility of the Senior Manager of Quality Control support and back up in oversight of the Finished Goods, Stability and Raw Material Laboratories, where the key areas are assurance of the cross-team collaboration, harmonization and simplification of the scheduling, testing, review and release of the materials and as a result an increase of the overall Brampton site output and productivity.

Duties and responsibilities

• Provide Leadership to the team of QC Raw Material Laboratory employees with the main focus on productivity, compliance intelligence, knowledge enhancements, employee’s development, performance management and effective planning.
• Design, develop and implement testing schedule, organize and monitor workload optimally to ensure all operations and tasks are performed within required turnaround time metrics and adherence to set schedules, accommodating testing requirements and meeting department goals. Design, develop and implement a structured team matrix for productivity, compliance and improvement ensuring sufficient amount of the personnel involved in the process, focusing on strategic longer term activities.
• Oversee & monitor Supervisors, ensuring implementation of continuous improvement and compliance initiatives of an overall QC Chemistry Laboratory.
• Lead & monitor for effectiveness and savings all activities associated with the reference standard program with the QC Chemistry Laboratories.
• Lead all activities associated with the appropriate qualification of the personnel including training and coaching, periodically assess performance and execute corrective actions as an outcome of this activity.
• Ensure effective cooperation of the team with the internal customers and stakeholders.
• Manage appropriate laboratory electronic system(s) access and training of the team, ensuring assignment of the appropriate user access roles to the personnel.
• Ensure staff are working in a safe environment and are complying with safety procedures at all times.  Perform monthly Health and Safety Audits, ensuring that the Supervisors are performing the safety awareness training in a timely manner. Respond to Health and Safety audit reports and proactivity address near misses.
• Ensure assessment of the CAPAs effectiveness and timely execution of all the associated actions.
• Support decision making on the product disposition where applicable.
• Responsible for overall day-to-day operation of the QC laboratory
• Plan, schedule, organize and monitor workload optimally to ensure all operations and tasks are performed within required turnaround time metrics and adherence to set schedules, accommodating testing requirements and meeting departmental goals
• Perform annual assessment of the personnel Job Descriptions correctness and obtain their annually executed approval from the employees.
• Streamline and implement Taro Certified Vendor Program in coordination with QA vendor management & supply chain teams.
• Designate for the role of Senior Manager of Quality Control (Chemistry), supporting all actions required for this role as applicable. 
• Aid in overseeing the performance of stability testing according to program schedule with the QC Supervisors.
• Oversee and support the QC Supervisors, to ensure all stability requirements for Operational Products are met on an annual basis
• Lead all activities associated with the laboratory investigations and CAPAs execution associated with the process owned by the QC Laboratories. Drive forward duties and work required to increase productivity and compliance with Purchasing, Vendor(s), Supply Chain, Warehouse and QA departments to ensure productivity and efficiency for the QC Laboratories Lead and advance analytical testing, review and releases  of chemical raw materials in a timely fashion to support operations.
• Aid the QC Supervisors to ensure analytical testing, review and releases of finished products & stability is completed in a timely fashion
• Design meaningful metrics associated with the QC Laboratories and perform effectiveness & robustness checks on the system and reporting its outcome to the site leadership at the established frequency. 
• Oversee and drive compliance programs for proper sampling and inspection of materials to increase productivity and compliance for the QC Laboratories. Maintain the sample retention program and archived record program for QC Laboratories, following established procedures.
• Lead, train, coach and periodically assess performance of QC Supervisors, Analyst & Laboratory Technicians and ensure continuous improvement for the QC Laboratories. Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
• Design & execute periodic assessment of robustness of the QC processes, ensuring a team focus on continuous improvement.
• Create, review and write procedures, focused on OneTaro key deliverables.  Lead and oversee this process within the QC laboratories.  
• Review current systems and procedures and implement changes where appropriate to improve productivity
• Provide analytical instrumentation support to the lab staff
• Ensure calibration programs are maintained and compliant to program
• Lead Vendor audits, focusing on contract laboratories for increased compliance and reduced costs, hold, quality meetings and drive quality and productivity programs
• Lead the QC Laboratory,  Warehouse and Supply Chain to proactively build quality  into the processes and systems
• Automates job functions to achieve efficiency improvements
• Other responsibilities and special projects as required.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s Degree in Science or related field
• Minimum 5 years supervisory experience in a pharmaceutical manufacturing environment
• Knowledgeable and experienced application of Health Canada and FDA regulations
• Ability to establish and maintain trusted and respected relationships with all internal and external stakeholders; demonstrated ability to work in a team environment.
• High energy level, ability to promote positive change and influence others
• Promote and maintain a lean culture
• Strong knowledge of analytical instrumentation
• Excellent written and oral communication skills with ability to articulate messages and interact with a variety of audiences (internal and external)
• Strong organizational, analytical, multi-tasking, detail oriented, trouble shooting, problem solving and root cause identification skills
• Proficiency with applicable software (LIMs and Empower)
• Ability to identify any deviations to procedures or systems and make recommendations for corrective measures
• In depth knowledge of GMP, FDA, HPFBI regulatory requirements and the associated guidelines.
• Ability to implement short range strategies and objectives towards enhancing the quality standards of the department
• Ability in dealing directly with Regulatory Agency officials (Health Canada, USFDA).

Working conditions

• Continuous walking and standing
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail

Physical requirements

Office based role

Direct reports

1 x Senior Analyst, QC

8 x Analyst

1 x Chemist