IT Application Manager, Electronic Batch Record

IT Application Manager, Electronic Batch Record

Category

Business Partner Functions - IT

Job Title

IT Application Manager, Electronic Batch Record

Company Details

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family-owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.

We have an opportunity for a IT Application Manager, Electronic Batch Record.

Job Summary

The IT Manager, Electronic Batch Record manages the entire eBR product stream globally and is responsible for associated costs, quality, deadlines and risk management. The manager is the product owner of the eBR and historian application suite once deployed. As such, this role plays a crucial role in the electronic batch record project and will lead a team of professionals and specialists globally to support this product stream.

PRIMARY DUTIES AND RESPONSIBILITIES:

As IT Manager:

1. As the system owner, ensures the eBR technology stack, including middleware and historian, is functioning properly: takes charge of all aspects of the system, including system availability, support and maintenance, configuration management (and/or code management), including change management and version management, infrastructure and vendor relationships, as applicable.
2. Acts as a business partner for user teams and solicits input from Operations and QA on product evolution proactively identifying opportunities for increasing value capture through new capabilities and use cases. Identifies new initiatives, prioritizes, and ensures execution.
3. Sets vision and strategic priorities for the team and technology, working with the department director to secure necessary funding on an annual basis.
4. Keeps business value & impact at forefront of product stream strategy (with a specific focus on reducing batch time to release and overall associated cost).

Responsibilities

1. Communicates on the value of the eBR product stream and provides ongoing recommendations to senior leaders and other department managers inside and outside IT.
2. Ensures systems are maintained in an updated and cyber security compliant state and monitors the general function. Manages engagement and escalation with supporting services in Engineering and IT, as well as external services, as required.
3. Partners with supporting services, including IT Infrastructure & Operations, IT Data & Analytics, and Engineering to ensure system availability and to deliver improvements and corrective actions as required.
4. Ensures that the product is maintained in a good operational, validated, and GxP compliant state.
5. Ensures that the functional and technical knowledge necessary for the sustainability of the product stream is maintained. This includes ensuring that an ongoing end user training program is maintained.

As Project Manager:

1. Drives roadmap implementation, makes recommendations, leads sprint execution with agile methodology, and makes/facilitates cross-cutting decisions, e.g. in the context of harmonization.
2. Manages all phases of the project (consultation, implementation, deployment).
3. Manages project resources with direct responsibility for external resources, i.e. integrators and software vendors.
4. Identifies and escalates risks, proposes mitigation measures and implements them when they are within the scope of responsibility.
5. Establishes and guarantees the schedule.
6. Secures the project budget.
7. Guarantees the quality of delivery (user experience, supported by appropriate end user training; GxP compliance; compliance with best practices for system configuration and development, to ensure application stability over time).
8. Delivers project reporting to ensure the best cost/quality/time/value/risk match.
9. Monitors project management indicators (performance evaluation, costs, deadlines, etc.).
10. Ensures the delivery of a system that is maintainable (from a cost and risk point of view).
11. Manages and/or participates in change management.
12. Contributes to the required governance related to the product stream. Ensures alignment with department director, project sponsor and other executives.
13. International travel: 10% to 25%

Leadership

1. Leads the performance and development of all direct reports.
2. Responsible for hiring, identifying skill gaps, and appropriate training/development of eBR staff in support of strategic objectives in accordance with company policies and procedures.
3. Ensures end user hardware and software assets are tracked, and software license compliance is maintained.

Qualifications

Education:
• Bachelor’s degree in computer science, data science, engineering, or equivalent.

Experience:
• 5 years of experience in a similar position, in a multi-site and multi-cultural context.
• Recognized managerial skills with 2 years of leadership experience overseeing a technical team.
• Energetic and passionate leader who inspires team to reach their full potential, championing a culture of transparency and trust.
• Experience in a regulated manufacturing environment (pharma or food) with knowledge of batch record and/or manufacturing execution systems and Industrial IT is an asset.
• Ability to articulate and optimize the design of solutions based on user and business value, lead ideation sessions and workshops.
• Strong communication and customer service skills.
• Strong financial and budget management skills, high-level stakeholder management, as well as vendor management skills.
• Strong knowledge of operational processes and compliance requirements, general knowledge of eBR tool, middleware, and historian technical capabilities and build tasks.
• In-depth knowledge of production, quality, and IT functional areas at the enterprise level.
• Working knowledge of enterprise IT architecture and application lifecycle management.
• Ability to work effectively in multidisciplinary and international teams, including synthesizing abstract ideas into concrete design implications.
• Proficiency in French is an asset.

What We Offer

• Excellent compensation/benefits package.
• Bonus and reward programs.
• Discounted gym memberships.
• Programs supporting work life balance.
• Employee recognition program.
• Professional and personal development programs.
• Social events and spirit days.

We are committed to diversity and inclusion and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier-free recruitment and selection process.