Role Summary:

The Director, Quality Control at OmniaBio is a key member of OmniaBio’s Site Leadership team. The person in this role oversees all cell and gene therapy Good Manufacturing Practices (GMP) quality control (QC) activities, which include analytical method transfer, validation, raw material and component testing, in-process control testing, final product testing, stability and comparability studies, and environmental monitoring. The role will be responsible for regulatory health authority interface for QC.

The Director, Quality Control will be a seasoned individual in the field of GMP manufacturing of cell and gene therapy products. The role will lead and develop OmniaBio’s testing and analytical method transfer services to cell and gene therapy and regenerative medicine producers. Responsibilities include providing technical leadership in client-facing projects and product supply, establishing analytical method transfer processes and policies, promoting manufacturing analytical interactions, providing technical input and guiding manufacturing strategy, coaching and mentoring employees, prioritizing work, and assisting in establishing long-term group direction and objectives.

Responsibilities:

QC and Leadership Responsibilities

• Design and establish the QC service program to support commercial manufacture for cell and gene therapy products.
• Oversee day-to-day QC operation.
• Identify and implement necessary infrastructure, facility and equipment required for QC operation.
• Develop short- and long-term strategic plans aligned with OmniaBio’s corporate objectives.
• Develop and implement groundbreaking approaches to high throughput QC testing and approval to support leading-edge business initiatives.
• Represent QC in customer-facing project teams using systematic methodologies/procedures to successfully transfer analytical methods in support of GMP manufacturing activities for late-phase clinical and commercial supply of multiple cell and gene therapy modalities.
• Accountable for the introduction and support of qualification of new analytical methods and equipment into GMP manufacturing, while managing technical risks associated with analytical transfer.
• Lead cross-functional teams to ensure relevant transfer and communication of critical analytical and technical information derived directly from the client or from early clinical phase manufacturing activity within CCRM.
• Ensure effective training programs are in place to train QC teams for execution and qualification of analytical methods to support technology transfer and ongoing support of manufacturing and manufactured products.
• Collaborate with the Materials Science and Technology (MSAT) team to establish material specifications and manage control of reference materials including, but not limited to, raw material, starting material, single use components, intermediate (in-process control) and products, storage and transport limits.
• Manage the program for retained materials and products.
• Review client analytical methods for GMP testing compliance.
• Define, review and approve QC documents, i.e., analytical overview, justification of specifications, development and investigative protocols and reports.
• Lead customer technical team meetings and serve as technical lead and subject matter expert at joint project team meetings.
• Operate with a continuous improvement mindset, providing guidance and support to continuous improvement activities and embedding the OmniaBio Operating Model (OBOM) as the modus operandi for the team.
• Provide leadership and management support for the very large team of QC scientists and GMP analytical personnel. Focus on developing individuals and overall effectiveness of the team.
• Responsible for resource allocation and project prioritization. Recruit, direct, coach and develop talent in the QC team to maintain a team with a high level of technical expertise that works collaboratively with key partners.
• Lead the budget planning process, including capital equipment and material needs, staffing requirements, and contracted services requirements.
• Manage the budget effectively to balance the operational needs and spend.
• Utilize operating metrics and key performance indicators to provide understanding of performance and drive improvement.

Operational Responsibilities:

• Work collaboratively with the Facilities team, equipment suppliers and Project Managers to develop scheduling windows within manufacturing operations with respect to QC equipment calibration and maintenance.
• Ensure quality assurance (QA) oversight on all QC-related activities.
• Report all out-of-specification (OOS) and out-of-trend (OOT), when applicable, to QA team and collaborate closely with QA to ensure thorough and comprehensive investigations are conducted.
• Ensure robust laboratory investigation process is in place, capable of detecting negative trends and correcting the issue. Put preventative actions in place.
• Escalate anomalies and concerns utilizing judgment as a seasoned leader.
• Represent QC in leadership forums.
• Support production schedule creation and resolve issues that may arise because of testing constraints impacting raw material availability or product release.
• Support the creation of client production budgets that align with current and future business objectives.
• Provide the sampling and testing functionality in support of environmental monitoring.
• Provide management and oversight of contract laboratory organizations.
• Be accountable for inspection interface for QC activities.
• Work with the Sterility Assurance function to assess results and data trends.

Business Support

• Assist Business Development to assess potential projects and to engage with prospective and current clients; finalize service agreements.
• Act as escalation with clients to tactfully manage issues arising as part of method transfer or QC testing.
• Work with Business Development to ensure the client service needs and offering are understood and acted upon.

Qualifications:

• PhD or master’s degree in science or bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc., or bachelor’s degree with strong experience.
• 10-15 years of experience in cell therapy/viral production, or similar within the pharmaceutical, medical technologies, biologics, or related industries.
• 10-15 years of experience in technical oversight of GMP quality control operations for a CDMO, a third-party testing facility, or a biotechnology company performing similar activities.
• GMP experience, supporting commercial manufacturing.
• 8+ years of practical experience in supervisory/leadership of large team.
• Strong understanding of biologics/cell manufacturing processes and technologies.
• Strong written English and oral communication.
• Must be able to travel domestically and internationally up to 10 per cent of the time.

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 establishing customer-facing organizations and service models.
• Demonstrated initiative and the ability to deliver high quality outcomes.
• Leads by example by proactively identifying problems and areas of improvement.
• Driven by understanding, meeting and exceeding customers’ expectations and requirements.
• Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
• Experience in supporting sales and operations planning (S&OP) and integrated business planning.
• Demonstrated ability to hire, coach and grow technical talent.

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.