Vice President Operations

**Reports to**:Vice President, General Manager and** **Site Head

**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.

**Role Summary**:
The Vice President, Operations, will be a key member of the Site Leadership team. The role oversees all cell and gene therapy clean room manufacturing activities, which includes various cell-based modalities and viral vector production. Products will service customer needs in support of clinical trials and ongoing commercial supply.

The Vice President, Operations, will be a seasoned individual in the field of Good Manufacturing Practices (GMP) manufacturing and organizational leadership. The person in this role will be responsible for providing oversight and support in client-facing projects and product supply. The Vice President, Operations, will represent the department in regulatory audits and provide guidance and support during client audits.

**Responsibilities**:

- Develops and implements all Operations Strategy.
- Designs and establishes a strategic manufacturing organization leading to 24/7 coverage of manufacturing assets.
- Be accountable for day-to-day manufacturing operations ensuring agreed-upon deliverable targets are met.
- Provides oversight of and supports manufacturing personnel to ensure employee engagement and operational success.
- Responsible for ensuring effective training programs are in place and supported to maintain and develop an effective workforce.
- Strategically leads resource allocation and project prioritization. Recruits, directs, coachs, and develops the Manufacturing team to maintain a high level of technical expertise, working collaboratively with key partners.
- Develops short-term and long-term strategic plans aligned with OmniaBio’s corporate objectives.
- Supports the development and implementation of electronic batch records and the manufacturing execution system.
- Drives health and safety performance; creates and maintains a safety-focused culture.
- Ensures the Manufacturing team has appropriate representation within customer-facing project teams.
- Collaborates with the Manufacturing, Science and Technology team to establish new production processes.
- Reviews and approves executed batch records.
- Operates with a continuous improvement (CI) mindset. Provides guidance and supports CI activities and embeds the OmniaBio Operating Model as the modus operandi for the team.
- Leads budget planning process including capital equipment and material needs, staffing requirements, and contracted services requirements.
- Manages budget effectively to balance operational needs and spend.
- Utilizes operating metrics and key performance indicators to provide an understanding of performance and drive improvement.
- Embeds key skills for investigation of non-conformance and root cause derivation.
- Collaborates with the Facilities team, equipment suppliers and Project Managers to develop scheduling windows within manufacturing operations for calibration and planned maintenance.
- Ensures quality assurance oversight on all manufacturing-related activities.
- Escalates anomalies and concerns, utilizing judgement as a seasoned leader.
- Represents the Manufacturing team in leadership forums.
- Supports production schedule creation and resolves issues that may arise.
- Supports the creation of client project production budgets that align with current and future business objectives.

Business Support:

- Assists the Business Development (BD) team in the assessment of potential projects and engages with prospective and current clients; finalizes service agreements.
- Acts as escalation point with clients to tactfully manage issues arising as part of technology transfer or ongoing manufacture.
- Works with the BD team to ensure client service needs and offerings are understood and acted upon.

**Qualifications**:

- Degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.).
- 15+ years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
- GMP experience supporting commercial manufacturing.
- 20+ years of practical experience in supervising/managing/leading large teams.
- Strong understanding of biologics/cell manufacturing processes and technologies.
- Strong English written and oral communication skills.

**Desired Characteristics**:

- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.
- Experience establ