Senior Manager, External Quality Business Processes and Strategic Projects

6010-Biosense Webster Inc. Legal Entity; Borgo San Michele; On-site; EUR 71,000 - 123,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Job summary

Johnson & Johnson is seeking a Senior Manager, External Quality Business Processes and Strategic Projects to lead EQ process improvements and strategic initiatives ensuring compliant and efficient execution.

The role focuses on establishing a Lean culture, leading data integrity governance, and cross-functional collaboration across platforms and sites. Travel up to 10% may be required.

Qualifications

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 10+ years of experience in Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry.
• Knowledge of quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review.
• Experience in FDA/EMA GMP-regulated environment; ISO awareness preferred.
• Proven project management skills; Lean/Six Sigma certification preferred.

Responsibilities

• Establish Lean culture within External Quality (EQ) using Lean, Value Stream Mapping to identify and deliver improvements.
• Owns and executes Root Cause Problem Solving to investigate and resolve issues.
• Facilitates complex investigations using advanced techniques (e.g., Kepner-Trego) and applies statistical analysis.
• Acts as EQ Data Integrity/Governance SPOC with cross-platform teams to support risk-based planning and remediation.
• Ensures knowledge management framework and cross-functional alignment across platforms.
• Represents EQ with Change Champion efforts to standardize processes and adopt SAP S/4HANA.
• Manages cross-functional risks and resources, defines KPIs, and drives QMR projects.
• Owns communication and change management across platforms; supports FDA BPDR submissions.

Skills

Quality Assurance

Project Management

Data Integrity

Regulatory Compliance

GMP Standards

Six Sigma

Budget Management

Leadership

Communication

Education

Bachelor’s degree in sciences

Master’s degree preferred

Job description

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, 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.

Preferred Skills

Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Cross-Functional Collaboration, Fact-Based Decision Making, ISO 9001, Mentorship, Organizing, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health
• service anniversary and recognition awards
• subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

Salary

The anticipated base pay range for this position is: €71,100.00 - €122,590.00

Additional information

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.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.