About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
The IT and Computer Systems Validation (CSV) Manager is responsible for the Information Systems and Computer Systems Validation departments to ensure that computerized systems are sourced, implemented, validated, and maintained in accordance with company standards, industry practices, cGMP requirements. The incumbent ensures that change management process, including GxP and Non-GxP systems, is effectively and efficiently functioning. Apotex Pharmachem Inc. supports a blend of remote and onsite working arrangements for management level employees. This position supports onsite employees, projects, regulatory inspections, business relationships, etc.
A minimum weekly onsite presence of 40% is required.
- Provides departmental leadership in managing Computer System Validation (CSV), IT/IS Infrastructure and IT related policies/procedures
- Represents the department during regulatory inspections.
- Develops and implements Electronic Records & Electronic Signature (ERES) compliance strategies for new and existing systems, including remediation of legacy systems.
- Develops and maintains global Change Control/Management that is effective and efficient.
- Ensures appropriate action is taken to record, anticipate, investigate and resolve problems in systems and services. Coordinates the implementation of agreed remedies and preventative measures.
- Work with the Director in developing KPIs/Metrics and ensure that the performance metrics for service delivery are met.
- Determines strategies to move the organization forward, sets goals, creates and implement action plans, and evaluate processes and results.
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Post-secondary graduate in computer science, engineering or similar.
- Strong knowledge/experience of regulatory requirements of US, Canadian and other countries regulatory agencies, including ERES regulations (i.e. 21CFR Part11 and Annex11).
- Complete understanding of computer system validation based on GAMP principles.
- Minimum five years’ experience in progressive IT roles, preferably in the pharmaceutical industry.
- Five years in a customer-centric service delivery role.
- Minimum three years’ experience in technology delivery capability.
- Minimum three years’ supervisory experience
- Strong IT service management knowledge/skillsets.
- Proven ability to lead direct reports and project teams.
- Demonstrated composure in demanding or stressful situations.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.