Senior Manager, External Quality Business Processes and Strategic Projects

About the role

Johnson & Johnson's Innovative Medicine division is looking for a Senior Manager, External Quality Business Processes and Strategic Projects, based in Dublin. The role drives the improvement of External Quality (EQ) business processes and leads strategic projects that ensure their compliant and efficient execution.

Key responsibilities

• Build a Process Excellence/Lean culture in EQ using methods such as Lean and Value Stream Mapping, and own the Root Cause Problem Solving process
• Facilitate complex investigations with techniques such as Kepner-Tregoe and apply statistical analysis to data sets
• Act as single point of contact for EQ Data Integrity/Governance, including designing the framework, supporting Site Quality Heads and driving gap remediation
• Ensure a sustainable knowledge management framework, including train-the-trainer sessions on Data Integrity/Governance
• Act as EQ SPOC and SME for TransCend and Batch Release Hub, supporting global standardization, process harmonization and S/4 HANA adoption
• Manage the P&O project portfolio, define and collect KPIs, and own the communication and change management framework
• Own the submission and support of FARs and BPDRs to the FDA, and act as backup for the EQ budget process

Required profile

• Bachelor's degree in a science (chemistry, biology, pharmacy, IT, engineering); master's preferred
• 10+ years of combined experience in QA, QC, validation or engineering in the pharmaceutical industry
• Working knowledge of quality systems (Risk Management, Investigation/CAPA, Change Control, Document Management, Management Review)
• Proven knowledge of Data Integrity regulations; FDA/EMA GMP and ISO experience preferred
• Proven project management skills, including process excellence; Six Sigma/Lean certification preferred
• Ability to work in a matrix organization, with up to 10% domestic and/or international travel

Required skills

• Data Integrity and quality systems
• Lean, Six Sigma, Kepner-Tregoe, Value Stream Mapping
• Preferred: BPM, Business Requirements Analysis, ISO 9001, SOPs, FARs and BPDRs

What we offer

• Base pay range of EUR 86,400 to EUR 148,350
• Annual bonus, vacation days, parental leave of at least 12 weeks, bereavement and caregiver leave
• Well-being reimbursement, health and financial programmes, and insurance plans where eligible