Senior Manager - QA Operations

About the role

The Senior Manager, Operations QA is a key role in the Quality Assurance team at the RayzeBio Indianapolis manufacturing site. This is a people manager position with supervisory responsibilities for up to 8 direct reports.

Responsibilities

• Provide leadership to ensure routine Operations Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Control Labs, and Supply Chain operational areas and systems.
• Have a comprehensive understanding of Radio-Pharma manufacturing processes to enable real-time decision-making.
• Advanced ability to synthesize information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
• Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to stop/continue manufacturing.
• Serve as a subject matter expert supporting others to navigate the RayzeBio quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.
• Evaluate, author, and/or review operating procedures (e.g., policies, SOPs, Wis) and perform other activities in support of quality operations.
• Provide direction and timely guidance to the staff regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational challenges.
• Accountable for the performance/delivery of the QA field quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
• Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project work.
• Aid in developing quality KPI/metrics to support GxP activities and/or for management reviews.
• Responsible for establishing, expanding, and maintaining RayzeBio GMP compliance program and building a positive quality culture at RayzeBio Indianapolis site.
• Champion a culture that embraces psychological and physical safety of employees in the work environment.
• Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
• Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed.
• Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues.
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
• Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and actively lead and conduct performance reviews for all direct reports.
• Applies AI to improve team execution and decision-making.

Qualifications & Experience

• Bachelor's degree in STEM field preferred.
• High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 10+ years of relevant cGMP experience, preferably with 5+ years of QA shop floor and/or QA operations.
• Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.
• Experience in FDA/EMA regulations in biopharmaceuticals, cell/gene therapy, and/or radio-pharmaceutical manufacturing is required.
• Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.
• Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Ability to think strategically, meet deadlines, and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Strong decision-making and ability to think creatively while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.
• Strategic thinking, with an enterprise-mindset, establishing deadlines and prioritizing work according to the needs of the business and within budget.
• Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks.
• Proactively finding solutions to quality and operational problems by creative thinking and innovative solutions.
• Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
• Ability to work within pharmaceutical cleanroom environments. Working Conditions
• Able to work near processing/handling of hazardous materials; including radioactive materials.
• This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.
• Able to gown for clean rooms such as ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).
• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.
• The employee must occasionally lift and/or move up to 30 pounds.
• Specific vision abilities required by this job include close vision and distance vision.
• The noise level in the work environment is usually moderate.
• Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).