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DTPPD MWS and Compliance Manager

Synthorx

Synthorx

Legal
Toronto, ON, Canada
Posted on Wednesday, August 9, 2023

Reference No. R2709385

Position Title: DTPPD MWS and Compliance Manager

Department: DTPPD MWS

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Position Summary:

This role functions as the main technical process leader for the area related to equipment, quality, and process in Washing and Sterilizing. The role provides leadership on improving overall performance for the Washing and Sterilizing operations. This includes safety, compliance, business process improvements and operational activities. This role will also focus on compliance aspect where the focus would be to execute critical, major, and minor deviations. The job will be focused on 60% as MWS shopfloor manager and 40% of the time will be allocated to work on deviations, CAPAs and CCRs. Sanofi Pasteur Limited is looking for motivated a results driven individual to join our DTPPD Department as a Production Manager.

Key Responsibilities:

Safety:

  • Accountable for a safe workplace by supervising and monitoring compliance with employment and health & safety legislation.

  • Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents.

  • Ensure critical incidents and accidents are reported to the appropriate authorities.

  • Ensure potential safety and health hazards are identified and known by staff and that protective equipment and clothing are required and are used.

Quality:

  • Ensure SOPs are current and adhered to; ensure BPR and logbooks are accurate and reviewed with minimal delay.

  • Ensure staff training records is complete and up to date.

  • Ensure process deviations and environmental incidents are minimized and root causes are identified and corrected; work with the team to decrease the human error deviations; develop ownership of the QNs, improve the organization around the tasks for full mistake.

  • Works with QOOQ and QOSA; ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge.

  • Lead inspection and own corrective actions; ensure the facility, process and documentation are inspection ready.

Delivery:

  • Ensures detailed schedule of W&S operations; ensure on time execution of the production schedule.

  • Set up delivery targets per shift and per area; ensure delivery of each area is tracked on a daily basis at the +QDCI and in the weekly update.

  • Ensures availability of raw materials, accuracy of inventory & recipes, trained staff, adequate SAP-trained staff, & maintenance & availability of validated facility and equipment.

  • Ensures production orders and SAP transaction and SPC data entries are maintained in a timely manner; share responsibilities for monitoring SPC, data review and control.

  • Monitors & communicates planned and actual equipment and operations using visible metrics.

  • Ensure minimal downtime of the equipment (training the operators on equipment troubleshooting, making sure the employees acquire the required knowledge of the equipment, proactively seeking for the appropriate departments to restore production).

Cost:

  • Assist in the annual departmental operating budget and non-strategic capital investment and monitor against spending.

  • Find ways to reduce overtime.

  • Assure adequate cross training of staff.

People and Development:

  • Lead and develops staff to ensure a high performing team; establishes, monitors and provides individual feedback on staff objectives; ensures training of staff according to training plans and to continue to develop their competencies; coach staff on personal development goals and document follow up.

  • Manage the team by organizing their daily activities, following up, and communicating the plan in advance.

  • Cascade information to and from staff, through verbal (+QDCI for example) and written communication (weekly update).

  • Ensure cohesion of the team and celebrate with the team.

  • Daily presence with the team on the shop floor is required.

  • Collaboration and strong customer oriented mindset within and outside DTPPD.

  • Hire new employees and follow company’s disciple procedures; responsible for attendance management and time reporting system.

Continuous Improvement:

  • Follows & enhances lean management systems; ensures continuous improvement processes; identifies root cause of production problems; identifies non-value added activities, other waste and potential improvements in process efficiency, quality and/or yield; implements solutions or changes via change control; plans and manages facility and organization improvements.

  • Provides metrics and other reports as requested.

  • Participates in special projects for production process improvement projects to simplify processes, meet GMP requirements, address inspection observations, new technologies and reduce costs to assist in development and quality goals.

Compliance Responsibilities:

  • Responsible for all critical, major and minor deviations associated with the Platform.

  • Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.

  • Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs.

  • Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.

  • Identify expertise required for the investigation (MTech, Technical Services, QC, QOVS, QOSA, etc.).

  • Identify, co-ordinate and manage contributions from other departments.

  • Participate in Autonomous Production Team (APT) support team meetings for planning and execution of investigations.

  • Review and provide guidance on reports prepared by technical staff.

  • Prepare manufacturing investigations to support other functional areas as requested.

  • Write and manage associated documentation, actions and timelines.

  • Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise and comprehensive.

  • Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines.

  • Ensure actions are assigned to the appropriate individuals and completed to meet timelines.

  • Develop appropriate corrective and preventive actions in collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause.

  • Initiate CAPAs in the Quality System as required.

  • Support manufacturing staff on updating GMP documents arising from CAPAs. Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders.

  • Work with Platform Leaders to identify and develop process improvements to remediate risks.

  • Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages.

  • Utilize the Deviation Review Board Governance as required. Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable.

  • Present and defend investigations and provide support to the area manager for process /procedure topics during Regulatory inspections and other audits.

Key Requirements:

  • Minimum Honors BSc in Microbiology/Biochemistry/Engineering or related Science with experience and additional business and management training (Preferred post-graduate in Microbiology/Biochemistry/Engineering or Related Science).

  • Minimum 5 years’ experience in Manufacturing in a pharmaceutical environment.

  • Minimum 2 years’ experience in managing or supervising a department with more than 5 employees.

  • Ability to lead and manage a diverse group of employees including indirect reports and peers.

  • Experience in lean manufacturing management systems and leads through changes.

  • Strong knowledge and familiarity with cGMP practices, with context of pharmaceutical/biological manufacturing.

  • Understanding of key activities including equipment cleaning, sterilization, operations of autoclaves, bottle washer, boiling sink; experience in validation, project management.

  • Previous knowledge and use of SAP software would be an asset.

  • Strong communication and technical writing skills.

  • Knowledge of Excel, Word, Outlook and PowerPoint.

  • Demonstrated ability to effectively manage time, people and projects.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi

#GD-SP #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.