GMP Quality Excellence Manager

Role Specific Responsibilities:
This role is responsible for the enterprise quality excellence agenda across GMP sites, with accountability for delivering measurable improvements in financial and operational performance through quality. This role provides functional leadership to site quality teams (matrix reporting) and may provide targeted interim leadership support to stabilize performance where required.
Value Creation & Quality Excellence:

• Lead and execute the GMP Quality Excellence strategy to deliver:
  
  • Reduction in cost of poor quality (scrap, rework, deviations)
  • Improvements in yield and right-first-time batch performance
  • Increased productivity through process standardization and waste elimination
  
  
• Establish and own value-linked KPIs, including:
  
  • COPQ reduction (% and absolute)
  • Right-first-time batch performance
  • Batch release cycle time (impacting working capital)
  • Customer complaint and deviation trends
  
  
• Identify and eliminate non-value-added activities within quality processes to improve efficiency and throughput
• Lead cross-site continuous improvement initiatives using Lean, Six Sigma, and root cause methodologic

Quality System Enhancement and GMP Compliance:

• Drive the effectiveness and efficiency of the Quality Management System (QMS) to support both compliance and operational performance
• Standardize quality processes, controls, and documentation across GMP sites to enable scalable and repeatable performance
• Ensure consistent application of GMP regulations while minimizing operational friction
• Conduct gap analyses and implement corrective actions to address compliance and performance gaps
• Lead and embed robust CAPA systems, ensuring sustainable resolution of systemic issues

Digital Enablement and Data-Driven Quality:

• Drive the adoption of digital quality solutions to enhance productivity, data visibility, and compliance
• Develop and implement data dashboards and reporting frameworks to provide real-time visibility of quality and performance metrics
• Leverage statistical and predictive analytics (e.g., SPC) to proactively identify risks and improvement opportunities

Customer and Commercial Alignment:

• Partner with commercial, supply chain, and operations teams to ensure quality performance supports customer retention, growth, and OTIF delivery
• Reduce customer complaints and quality-related disruptions that impact revenue and reputation
• Embed customer-centric quality practices into site operations

Auditing and Inspection Readiness (Risk Mitigation):

• Ensure GMP sites maintain a state of continuous audit readiness, reducing regulatory and operational risk
• Lead internal and external audits and regulatory inspections
• Analyze audit findings and drive actions to strengthen compliance and prevent recurrence
• Mitigate risks that could impact site operations, product supply, or regulatory standing

Capability Building and Culture:

• Build quality capability across GMP sites through structured training, coaching, and leadership development
• Develop site-level quality leadership to enable sustainable, self-sufficient performance improvement
• Foster a culture of accountability, continuous improvement, and operational excellence

Collaboration and Communication:

• Collaborate across sites and functions to drive enterprise-wide alignment and knowledge sharing
• Partner with Operations, Engineering, Supply Chain, and Commercial teams to integrate quality into business decision-making
• Influence senior stakeholders to drive balanced outcomes across compliance, cost, and performance

Compliance:

• Complies with company Health, Safety and Environmental policies, procedures, and arrangements
• Reports all Health, Safety and Environmental accidents, incidents and near misses promptly
• Acts in a safe and responsible manner at all times

Problem Solving and Innovation:

• Active participation in continuous improvement activities
• Participates in problem-solving
• Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
• Assists in the training, mentoring, and assessment of other team members
• Exercises autonomy and judgement subject to overall direction or guidance

Education and Qualifications:

• BS degree in Chemistry or Engineering with a MS preferred
• Strong knowledge of ISO 9001 and CGMP regulations (e.g., 21 CFR Parts 210 and 211)
• ASQ certification (CQE, CQA or CMQ/OE) preferred
• Knowledge of internal auditing required
• Lean and/or Six Sigma certification preferred

Experience:

• Minimum of 7 years of QA/QC experience in a CGMP environment (Food, API, Excipient or Pharmaceutical manufacturing)
• Experience leading multi-site or regional/global quality initiatives
• Proven track record of delivering measurable improvements in quality, cost, or productivity
• Experience in data-driven decision-making and statistical process control
• Demonstrated leadership in continuous improvement and transformation initiatives

Knowledge, Skills, and Abilities:

• Strong analytical and data-driven decision-making capability
• Ability to translate quality performance into business and financial impact
• Strong stakeholder management and influence skills within a matrix organization
• Demonstrated business acumen and understanding of value creation levers
• Proficient in Microsoft Office tools; SAP and digital QMS experience preferred
• Embodies the core values of Aurorium:
• credible:keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions
• outcome-oriented:adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact
• driven:passionate about delivering authentic, world-class experiences that engage customers and inspire greatness
• empowered accountability:empowered to achieve common goals and accountable for delivering performances and results that exceed standard.

If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. Apply today!

Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays.

Aurorium is a global Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on gender, sexual orientation, gender identity, race, ethnicity, religion, age, veteran status, disability status, genetic information, or any other protected category.#LI-Onsite