(Day Shift) Senior Manager, Shop Floor Quality Assurance

About the position

As the Senior Manager Days, Quality Assurance Shop Floor (QASF) you play a pivotal role in ensuring the highest quality standards in our cGMP processes. This is not just a job; it's an opportunity to lead, innovate, and make a significant impact on our organization. As a critical on-site leader, you will be at the forefront of our day shift operations, driving excellence and fostering a culture of quality. You'll be responsible for the staffing, training, and leadership of two day-shift managers and their respective teams, ensuring they are equipped to meet and exceed quality standards. Work in a dynamic setting where your ability to cross-functionally influence and improve quality standards will be highly valued. This role offers a unique blend of technical challenges and leadership opportunities, perfect for someone with a strong desire to learn and grow.

Responsibilities

• Lead and mentor day-shift managers and their teams, ensuring effective communication and high performance.
• Uphold and improve quality standards through cross-functional collaboration and influence.
• Develop and implement training programs to enhance the technical acumen and effectiveness of the day-shift teams.
• Utilize analytical thinking to solve complex quality issues and drive continuous improvement.
• 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.
• Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management.
• Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events.
• Accountable for the performance/delivery of the QA field quality organization.
• 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.
• Champion a culture that embraces psychological and physical safety of employees in the work environment.
• Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners.
• 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.
• 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.
• Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor.
• 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.

Requirements

• Ability 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.
• Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles.
• Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality.
• Proactively finds 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.
• Ability to understand complex problems with multiple datum/variables and articulate practical solutions.
• Excellent technical writing/verbal skills.
• Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records.
• 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.
• 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+ year of manufacturing site experience.
• Ability to work within pharmaceutical cleanroom environments.

Benefits

• Competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.