Senior Manager, External Quality Business Processes and Strategic Projects

Purpose

The Senior Manager, Business Processes is accountable for driving the improvement of External Quality (EQ) business processes and for leading strategic projects that ensure their compliant and efficient execution.

Key Responsibilities

• Establishes a Process Excellence/Lean culture within EQ, using existing methodologies (e.g. Lean, Value Stream Mapping) to identify and deliver improvements.
• Owns and executes the Root Cause Problem Solving process to investigate and solve issues systematically.
• Facilitates complex investigations using advanced techniques (e.g., Kepner-Tregoe) and applies statistical analysis to various data sets.
• Acts as single point of contact (SPOC) for EQ Data Integrity/Governance: design and implementation of the EQ Data Integrity/Governance framework, together with a Data Integrity/Governance team representing each platform, supports the Site Quality Heads in the risk-based definition and execution of the plan and drives sustainable Data Integrity/Governance gap remediation, reuse of solutions and continuous improvement across the platforms.
• Ensures a sustainable knowledge management framework across the platforms, including initial train-the-trainer sessions on Data Integrity/Governance.
• Acts as EQ SPOC and SME for TransCend and Batch Release Hub.
• Represents EQ by providing quality perspectives, requirements and compliance standards, and acts as Change Champion across EQ to support global standardization, process harmonization and S/4 HANA adoption.
• Ensures cross-functional alignment, assesses business risks and develops mitigation strategies.
• Ensures any asks of EQ are understood and appropriately and timely resourced.
• Actively manages the P&O project portfolio.
• Defines and collects KPIs to support platform metrics and QMR (specific projects).
• Owns the communication and change management framework across the platforms (specific projects).
• Owns the submission and support of FARs and BPDRs to the FDA.
• Acts as back-up for the EQ budget process.
• Responsible for any other projects that may arise over time.
• Maintains compliance with all company policies and procedures.

Qualifications

• University/Bachelor's degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering) required; Master's degree preferred.
• 10+ years of combined experience in Quality Assurance, Quality Control, Validation or Engineering in the pharmaceutical industry is required.
• Broad understanding of the quality organization (e.g., quality operations, quality systems) preferred.
• Working knowledge of quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review required.
• Proven knowledge of applicable Data Integrity regulations required.
• Working experience in an FDA/EMA GMP-regulated pharmaceutical environment and familiarity with ISO requirements preferred.
• Proven project management skills and experience, including knowledge of project methodologies and process excellence, required.
• Six Sigma and/or Lean certification preferred, or willingness to obtain it.
• Budget management experience preferred.
• Quality mindset and ability to enable Critical and Design Thinking, with a risk-based approach that gives full consideration to patient safety and quality.
• Strong problem-solving and conflict-resolution skills; able to analyze complex problems under pressure, reach valid conclusions and deliver solutions, acting independently and knowing when to involve others.
• Results-oriented, with a strong track record of delivering on objectives; sense of urgency and ability to zoom in and zoom out.
• Strong leadership and facilitation skills; able to build productive partnerships and to influence and negotiate effectively at all levels, including without line authority, to drive harmonization.
• Experience working in a matrix organization and collaborating across functions in a local and global context, including with remote teams, while managing complexity.
• Strong communication (verbal, written and presentation) and interpersonal skills, self-awareness and adaptability required.
• Passion for sharing knowledge and facilitating the learning of others.
• Demonstrated ability to rapidly learn, evaluate, and adopt new AI tools and ways of working to meet evolving business needs.
• This position may require 10% of domestic and/or international travel.