OmniaBio: Manager, Master Data Governance
3 weeks ago
Friday, January 26, 2024
About OmniaBio:
OmniaBio Inc. is a subsidiary of Toronto-based CCRM ( ccrm.ca ), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.
Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.com to learn more.
Role Summary:
Reporting to the Senior Director, IT-GMP Systems, the Manager, Master Data Governance is responsible for managing and governing all enterprise master data and associated processes; and ensuring data accuracy, completeness and compliance with corporate policies and regulatory requirements (privacy, security and Good Manufacturing Practices (GMP)).
Responsibilities:
- Develops, implements and maintains master data governance policies and procedures to ensure the accuracy, completeness and timely availability of data across the organization.
- Collaborates with cross-functional teams to identify and prioritize data management and analytics initiatives.
- Owns and drives mobile device management (MDM) roadmap items spanning systems (e.g. ERP, LIMS, MES), governance, process, people and data culture.
- Assesses and proposes solutions for specific MDM challenges.
- Ensures compliance with applicable data privacy, security and GMP regulations, and corporate policies.
- Develops and implements a data governance organization, including identification and training of data stewards.
- Provides leadership and mentorship to the extended master data management team (i.e, data stewards).
- Builds organizational capability in data management best practices by preparing and delivering training sessions.
Qualifications:
- Bachelor’s degree, or equivalent academic qualification, in computer science/engineering, information systems, data management or related field.
- At least fiveyears of work experience with extensive knowledge of master data governance.
- At least three years of work experience in a leadership role.
- Extensive knowledge of enterprise data architectures and MDM tools and best practices.
- Experience working with SAP ERP (S4/HANA preferred).
- Excellent communication, interpersonal and leadership skills.
- Experience leading cross-functional teams and developing data-driven solutions. Candidates should be comfortable working in a fast-paced environment and possess excellent communication and leadership skills.
Desired Competencies:
- Experience with master data governance within a pharmaceutical manufacturing environment (e.g. ERP, LIMS, MES).
- Experience in a pharmaceutical manufacturing (clinical and/or commercial) environment.
- Understanding of GxP regulatory requirements (e.g. 21 CFR Part 11, Annex 11, GMP).
- Analytical skills and strong organizational abilities.
- Attention to detail and problem-solving aptitude.
- Ability to work within a matrix organizational structure.
- Experience working with cloud-based architectures (e.g. Azure, AWS) and SaaS applications.
- Experience implementing cloud-based analytics platforms (e.g. SAP Analytics Cloud, Power BI).
OmniaBio Inc. is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
OmniaBio Inc. is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
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