OmniaBio: Manager, CQV

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.comto learn more.

Department:       Facilities and Engineering

Position Summary

As Manager, Commissioning, Qualification and Validation (CQV), you will manage CQV activities such as the development of a validation master plan(s), and qualification/validation of deliverable(s) and standard operating procedures (SOPs). The person in this position provides leadership in a first-line management capacity by training, mentoring and supervising CQV staff to complete projects and departmental goals safely, efficiently and economically.

Responsibilities:

• Leads overall accountability for the validation program, including the CQV master plan and deliverable document development, which encompasses equipment; facilities; utilities; computerized systems; and cleaning and processes installation qualification, operational qualification,and performance qualification. Ensures these documents meet the minimum regulatory requirements at an appropriate level of validation. Collaborates with key stakeholders and user groups, including the Manufacturing Science and Technology , Process Development, Operations, Information Technology and Quality Assurance teams,and clients, to accurately develop documentation requirements.
• Manages the development and welfare of an assigned team of CQV personnel.
• Directs and manages CQV consulting parties.
• Manages the preparations, revisions and updates schedule for validation activities.
• Performs departmental review of qualification-related documentation.
• Establishes and maintains a qualification documentation periodic review schedule.
• Develops SOPs, preventive maintenance and calibration programs.
• Develops and maintains temperature mapping requirements, protocols and schedules.
• Contributes to alarm rationalization assessments and management of required alarm documentation. 
• Prepares and manages the timely completion of all departmental tasks, including deviations, change control, impact assessments, corrective and preventive action, and other associated records.
• Leads cross-functional personnel to develop documented risk assessments and mitigation strategies, as required.
• Monitors SOP periodic review cycle timelines to ensure timely review of CQV SOPs.
• Supports the environmental monitoring program.
• Contributes to facility cleaning strategies and compatibilities.
• Participates in regulatory, customer and internal audits as a subject matter expert.
• Meets all deadlines associated with projects as directed, including all reports and documentation.
• Keeps the Manager, Facilities and Engineering updated on all schedules, qualification testing results, and all other departmental activities.
• Creates departmental key performance indicators and measures achievement against target goals.
• Participates and leads employee activities, including hiring; performance conversations with employees, such as monthly one-on-one meetings to connect about performance; check in on employees’ progress toward achieving objectives, offering support and removeing barriers; and communicates and revisits performance expectations to reinforce and encourage high performance.
• Utilizes open, honest, two-way communication to build trust-based relationships with employees, business partners, and direct leaders, while continuously improving leadership capabilities by personally seeking feedback and development.
• Ensures adherence of team members (direct reports) to all compliance programs and company policies and procedures.
• All other duties, as assigned.

Requirements:

• 8+ years of experience in a related CQV position in a biopharma/pharmaceutical Good Manufacturing Practices environment.
• Minimum of 5 years of direct supervision of personnel.
• Post-secondary education in engineering technology or similar qualification preferred.
• Strong English written and oral communication skills. 
• Experience participating as a subject matter expert in regulatory inspections.
• Knowledgeable of the regulatory guidance for related aseptic, cell and gene therapy, and regenerative medicine (e.g. Health Canada, U.S. FDA, EMA, ICHQ7, GAMP5, 21 CFR Part 11, ISPE, EU Annex, USP <1079.)
• Experience with qualification of HVAC systems and Grade A, B, C and D clean rooms.
• Experience with qualification of manufacturing automated systems/programmable logic controller systems.

Desired Characteristics

• Strong understanding of an aseptic manufacturing facility andcell manufacturing/viral vector-related equipment and technologies.
• Independent, detail-oriented self-starter with excellent analytical skills, with the ability to multitask and succeed in a team environment.
• Strong communication skills and ability to work with internal and external partners.
• Strong people leadership experience with ability to manage organizational change, particularly through transformative growth and development.
• Strong technical writing skills.