Operations Compliance Manager

2 weeks ago

Montreal, Quebec, Canada Pharmascience Full time

The Operations Compliance Manager is responsible for overseeing the entire lifecycle of deviations, CAPAs, and change controls, ensuring their timely and effective completion for Operations (manufacturing, packaging, maintenance, and warehouse). This includes coordinating and tracking activities, managing the investigations team, and supporting the development and implementation of robust CAPAs. The role also involves facilitating communication and collaboration between different teams, tracking progress, measuring KPI impact, and recommending improvements. Additionally, this position is responsible for preparing and maintaining KPI dashboards, scheduling recurring meetings, and overseeing trend analysis meetings. The manager in this position is also responsible for ensuring the implementation of processes and means to remove production blockers (e.g., NOGOs).

Responsibilities & Duties:

  • Oversee the planning, execution coordination and follow-up of deviation, CAPA and change control activities, ensuring timely completion and effectiveness.
  • Manage the investigations team (Supervisor and investigators).
  • Support deviations to ensure robust CAPAs are proposed and implemented.
  • Execute and Close assigned CAPA and change control activities as well as support others to avoid late activities.
  • Issue deviation, CAPA and change control extension requests.
  • Facilitate communication and collaboration between task owners, Operations, and QA throughout the deviation, CAPA and change control lifecycle.
  • Track the implementation progress of CAPA, change control actions, measure their impact on KPIs, and recommend further improvements when necessary.
  • Prepare and maintain KPI dashboards.
  • Schedule recurring meetings to discuss progress and KPIs with task owners and/or their direct managers

Data Analysis, Root Cause Identification and Effectiveness Checks:

  • Conduct in-depth analysis of deviation data to identify recurring problem areas and trends.
  • Implement follow-up mechanisms and data trending tools & statistics to monitor the effectiveness of CAPAs.
  • Proactively identify and assess potential compliance risks, recommending enhancements to processes or systems to mitigate them.
  • Develop and implement targeted programs and training initiatives to address identified root causes and prevent future recurrences.

Inspection and audit support:

  • Support external, internal, and regulatory audits and inspections.
  • Prepare (with the department manager) the audit and inspection observation answers.
  • Ensure all non-compliance issues are addressed promptly and effectively

Continuous Improvement and Coaching :

  • Participate in NOGO (Production Quality Blockers) meetings.
  • Support the coaching of employees to improve their quality & compliance behaviors.
  • Participate in the implementation of key initiatives (e.g., Electronic Batch Records, improvement of documentation & GDPs, implementation of deviation SWAT or equivalent programs).
  • Conduct regular training sessions to educate Operations staff on compliance best practices, updates, and address identified knowledge gaps.

Daily Operations Support :

  • Participate in NOGO (Production Quality Blockers) meetings.
  • Manage actions to lift NOGOs.
  • Prepare and/or coordinate the corrective protocols.

Skills, Knowledge & Abilities:

  • Written and oral proficiency in French, ability to communicate in English (oral and written).
  • Experience with managing a high volume of deviations, CAPAs and change controls.
  • Knowledge of relevant pharmaceutical industry regulations.
  • Coaching and training abilities with small and medium size groups.
  • Capacity to effectively manage time and priorities.
  • Capacity to manage several projects simultaneously.
  • Process improvement mindset.
  • Capacity to adapt.
  • Facility to interact and excellent aptitude to communicate with people.
  • Collaboration and team spirit.
  • Advanced proficiency with MS Office.

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