Director Quality Control

SUMMARY

Leads and manages the QC laboratories within Biologics Manufacturing under cGMP regulations in a multi-product facility for clinical and commercial supply.

Responsible to put in place a strategy to include also additional QC services for non-biologics business (e.g. stability) Provides leadership, direction and oversight to the associate team.

Develops a flexible QC service able to answer the needs of the routine manufacturing, troubleshooting support and new process/product introduction

Is responsible to meet financial and quality performance goals and also responsible for supporting regulatory inspections and audits.

DUTIES AND RESPONSABILITIES

• Serves as leader in the QC Laboratories

• Plans, directs and effectively manages work to meet quality, productivity and efficiency goals:
  • Ensures the safety of work practices in accordance with the safety program and the local law
  • Ensures that all the QC activities are in compliance with cGMPs
  • Ensures staff training to perform their job responsibilities
  • Provides technical leadership for all QC activities
  • Develops strategies that ensure achievement of objectives that are consistent with the site’s strategic direction
• Accountable for new process/product introduction and provides scientific, technological support for the technical project phase, process transfer, scale-up, validation, troubleshooting and regulatory filing activities.
• Responsible to deliver flexible support to the manufacturing team for troubleshooting and investigation analytical support.
• Responsible to efficiently plan and organize the QC activity to meet the production planning goals.
• Oversee standard release assay panel development for drug substance and in process control.
• Lead clinical phase-specific product characterization and comparability studies required for regulatory filing
• Responsible for the QC group annual budget and quarterly forecasting processes
• Manage headcount and expenses to meet approved spending plan while achieving all departmental commitments and project objectives
  • Reviews all changes at the site and any of specified contractors in collaboration with Quality Assurance
  • Collaborate with the management team in resolution of any problems, provide analytical support and assure effective corrective actions roots causes.
  • Define staff objectives, create development plans, provide individual mentoring and performance feedback/formal reviews
• Assure site readiness for regulatory inspections including providing support for inspection preparation activities
• Ensure key Quality metrics are maintained, including, documentation availability, training, investigation closure, change control implementation, analytical result review, lot disposition, etc…
• Close engagement with cross-functional counterparts and teams; serving as a key interface with Manufacturing, Quality Assurance, Manufacturing Science & Technology, Engineering & Maintenance and Environment, Health and Safety
• Represent the QC operations during internal or external audits
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

REQUIREMENTS

• Master Degree in relevant filed such as Chemical Engineering, Bio- engineering, Bioprocessing with minimum of ten years’ experience, or at least 15 years’ experience in QC laboratories operation or; PhD Degree with six years of direct experience.
• A minimum of 4 years leadership experience required with demonstrate ability to set vision and direction for a team including setting expectations and motivating results
• Experience with Quality systems such as Deviation, CAPA, Change control systems required
• Experience in troubleshooting, investigation, root cause analysis in a cGMP environment required
• Experience in working on multiple new product introductions and life-cycle management
• Broad knowledge of Pharmaceutical Quality, Manufacturing and GxPs practices; ability to force cross functional partnerships and strategies; ability to understand/evaluate/anticipate business and organizational issues to develop and implement solutions.
• Leadership; ability to build trust and create collaborative environment and relationships
• Fluent in English and French
• Available to travel
• Excellent written and verbal skills

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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