Senior Manager, Quality Assurance Shop Floor 2nd Shift

About the role

The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people leader. The incumbent manages front line managers, and their teams, and will play a pivotal role in ensuring the highest quality standards in our cGMP Cell Therapy processes.

Responsibilities

• Lead and mentor night-shift managers and their teams, ensuring effective communication and quality performance.
• Uphold and improve quality standards through cross-functional collaboration and influence.
• Develop and implement continuous improvement efforts to enhance the quality and compliance acumen and effectiveness of the night-shift teams.
• Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems.
• Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
• Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.
• Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues.
• 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.
• Champion a culture that embraces psychological and physical safety of employees in the work environment.
• Lead and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams.
• Act as a QA subject matter expert on behalf of the facility during audits and inspections.
• Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs.
• 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 conduct performance reviews for all direct reports.

Qualifications & Experience

• Able to lead on-site quality operations teams working 12-hour shifts on a rotating 2-3-2 Panama schedule.
• 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.
• Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget.
• Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks.
• Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality.
• Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.
• Ability to understand complex problems with multiple datum/variables and articulate practical solutions.
• Excellent technical writing/verbal skills. Ability to effectively present technical data based on target audience.
• 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.
• Ability to lead change in a fast-paced environment with limited information and/or time-constraints.
• Skilled in building relationships, influencing across the matrix, and coaching others to drive results.
• Fosters a positive team environment and culture by being a mentor to, and advocate for, team-members.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.
• Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.
• Master’s degree in STEM or an MBA preferred.
• Bachelor/Associates degree with equivalent combination of education and work experience is considered.
• 8+ years of relevant cGMP experience, preferably with 4+ years of manufacturing site experience.
• Able to work within pharmaceutical cleanroom environments.