- JOB OBJECTIVES Responsible for identifying, analyzing, and addressing process and performance gaps within production and related support services. The role ensures the accuracy of documentation, implements sustainable solutions, supports the execution of corrective and preventive actions (CAPA), and leads and designs continuous improvement initiatives across various sites. Responsible of leading improvement activities and process/procedure changes by collaborating closely in a multidisciplinary environment. Responsible for reviewing and approving documents, procedures, deviations, change controls, and other production-related documents in collaboration with the Head of Pharma, as well as for acting as the Tier 2 replacement for the Head of Pharma when necessary. 2.

PRIMARY FUNCTIONS Process Improvement & Execution Identify operational gaps in production and supporting processes and drive the actions required to close them. Translate process needs into concrete deliverables (documents, procedures, workflows, tools). Ensure that improvements are practical, sustainable, and aligned with sterile manufacturing requirements. Coordinate with cross-functional teams to ensure solutions are implemented effectively and on time.

Documentation

Ownership & Standardization Lead updates and creation of required documentation (SOPs, forms, batch records, workflows) linked to process improvements. Ensure documentation accurately reflects operational reality and supports compliance requirements. Harmonize documents and practices across sites.

Continuous Improvement

Act as a change agent to improve efficiency, robustness, and compliance in production processes. Apply continuous improvement methodologies (Lean, root-cause analysis, standard work, etc.) to identify and resolve issues. Monitor the impact of implemented solutions using KPIs and ensure long-term process stability.





CAPA & Compliance Support Participate in non-conformance investigations and propose appropriate CAPA. Lead the implementation of CAPA actions related to procedures, documentation, and process improvements. Ensure all actions align with GMP and sterile manufacturing expectations.

Cross-functional Coordination Work closely with Production, QA, QC, Engineering, Supply Chain, and other stakeholders to ensure improvements are fully adopted and effective. Facilitate alignment meetings, problem-solving discussions, and follow-ups. Serve as a key integrator who connects documentation, people, and processes.

Project Leadership

Lead and execute assigned improvement projects from initiation to completion, without direct staff management. Define timelines, deliverables, responsibilities, and follow-up mechanisms. Communicate progress and escalate risks or delays when needed across both sites. 3.

EXPERIENCE REQUIREMENT AND APTITUDES Bachelor’s degree in engineering or science, or relevant experience, including training in microbiology. At least 5 years of experience in the pharmaceutical/biopharmaceutical industry or an equivalent sector. Knowledge of project management methods.

Knowledge of Good Manufacturing Practices (GMP). Understanding of structures and manufacturing processes for sterile pharmaceutical products. Bilingual (French and English) with excellent written and oral communication skills.

Proficiency in computer tools, particularly the Microsoft Suite. Strong organizational skills. Ability to synthesize information for system design and engineering. Analytical and problem-solving skills.

Positive interpersonal skills and ability to work collaboratively with peers. Ability to lead, guide, and participate in various cross-functional teams. Customer satisfaction oriented. Analytical and problem-solving skills.

Sound judgment, entrepreneurial spirit, autonomy, and initiative. Ability to work under pressure with tight deadlines and frequent priority changes.

📌 PRODUCTION EXCELLENCE MANAGER (Canada)
🏢 JUNO PHARMA CANADA
📍 Canada