Sr. Manager of Manufacturing Quality

Who we are:

Oncocyte is a precision diagnostics company. The Company's tests are designed to help provide clarity and confidence to physicians and their patients.

Mission of the role:

The Sr. Managerof Manufacturing Quality oversees the Quality work and is responsible for establishing and maintaining a robust quality program to effectively support Oncocyte's Manufacturing Operations.

The Sr. Managerof Manufacturing Quality reports to the head of Quality and Regulatory. The key duties include quality oversight and support of Manufacturing operations and pharma services, incl. RUO and IVD products manufacturing QC, root cause investigations, and quality process improvements. A track record of learning new processes, taking on varying tasks/projects, and impeccable attention to detail is essential for this role.

The Sr. Manager of Manufacturing Quality works with the Regulatory team to support related compliance (including leading and trending CAPAs, NCRs, etc.), continuously improve the quality management system (QMS) and assist in the preparation of necessary documents for submission of IVD products for US FDA and/or CE marking.

Your day-to-day:

• Lead the Quality team and delivering and maintaining a quality management system for Oncocyte's cGMP manufacturing processes and Oncocyte's RUO products.
• Review and approve Quality System documents including but not limited to, procedures, work instructions, investigations, complaints, CAPAs, NCRs, qualification protocols, and test reports.
• Assist the regulatory and R&D teams on product submission reports.
• Establish and maintain QC test procedures for manufacturing of IVD kits, kit components for RUO kit production.
• Collaborates with the entire Quality & Regulatory team and other stakeholders to make the Nashville location fit for ISO13485 accreditation.
• Coordinate the quality review of supplier qualifications and approval processes.
• Oversee the quality control and production functions at all sites.
• Promote awareness of applicable regulatory requirements, including QMS requirements and customer requirements throughout the organization.
• Ensure GMP and RUO Manufacturing quality control records are maintained.
• Support investigations and complaint handling.
• Lead activities related to internal audits and inspection readiness.
• Ensure that all established and appropriate process controls, procedures, and written work instructions are adopted and/or prepared particularly where their absence would affect quality.
• Report on patterns, trends, and other quantifiable measurements to determine the effectiveness of the QMS and related processes.
• Assist in determining the priority of urgent items and appropriate action plan to effectuate priority.
• Provide SME guidance and support for stakeholders, including product Legal Manufacturer R&D and Product Support teams, Commercial Operations Technical Support teams, Manufacturing operations, QA Operations and Regulatory.
• Support laboratory transfers and product launches.
• Lead or contribute to cross-functional teams in the execution of continuous improvement projects to drive efficiencies and improve quality.
• Mentor/coach team members across the organization in quality practices.
• Assist in establishment of standards for the acceptance of testing data by devising evaluation tests, methods, and procedures.
• Ensure quality and reliability standards are met by studying product and consumer requirements with other members of management and with laboratory operators, technicians, and scientists.
• Review project plans for quality requirements prior to launch.
• Oversees quality assurance operational requirements by scheduling and assigning employees and following up on work results.
• Collaborates with technical staff to develop risk management documentation.
• Collaborate on software requirements/specifications and provide quality feedback.
• Other tasks as assigned.

What it takes to do this job:

• Bachelor's degree or equivalent in a scientific, technical, or engineering discipline.
• 7+ years' experience working in a regulated industry (i.e., laboratory, medical device, pharma and/or biotech) and experience with risk management regulations and standards, including FDA 21 CFR 820, IVDR, ISO 13485, ISO 14971.
• Knowledge and demonstrated experience with IVDs is preferred.
• Experience working in a global organization and/or interfacing with multiple locations a plus.
• Experience in performing system risk assessments and reviewing PFMEAs.
• Working knowledge of hosting and managing regulatory audits is preferred.
• Change management and facilitation skills.
• Knowledge of quality concepts and tools.
• Ability to provide technical expertise on quality topics related to IVD manufacturing.
• Demonstrate ability to work in a dynamic, collaborative environment.
• Strong written and oral communication skills, including an ability to articulate ideas clearly and appropriately influence others.
• Well versed in project management skills.
• Ability to thrive in a demanding, change-oriented, fast paced environment requiring a high degree of deadline-driven productivity.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Exceptional ability to work autonomously within a distributed team setting in a dynamic work environment that often requires management/completion of multiple concurrent tasks within close deadlines and high demands, with a high degree of accuracy and detail.
• Creative and analytical thinker with strong problem-solving skills.
• Ability to work independently and manage multiple tasks while meeting deadlines.
• Willingness to demonstrate Oncocyte's values by acting with integrity, respect, trust and possess a very positive attitude and an understanding of the dynamics involved with organizational growth and change.

Who you are:

• You have a "do what it takes - no job is too small" team player and positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally.
• Your organizational skills, attention to detail, and ability to multi-task are excellent.
• You exhibit ethical and professional behavior at all times.
• You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to:

• Improve patient outcomes.
• Meaningfully impact the company's short-term and long-term success.
• Work collaboratively across all levels within the organization.
• Grow your role as you see fit.
• Learn everything there is to know about cancer diagnostic laboratories.
• Create an inspiring workplace.