Senior Manager, External Quality Business Processes and Strategic Projects

Company Profile

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-110332, Ireland R-110334, Italy R-110335, Switzerland R-110333, United States of America R-108589. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function

Quality

Job Sub Function: Business Process Quality

Job Category: Professional

All Job Posting Locations: Latina, Italy

Job Description

We are searching for the best talent as 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, acti