Senior Manager, External Quality Business Processes and Strategic Projects

Biopharma Asia; Dublin; On-site; EUR 86,000 - 148,000; Full time

Job summary

Johnson & Johnson seeks a Senior Manager, External Quality Business Processes and Strategic Projects to drive process improvements across External Quality (EQ). You will lead initiatives using Lean and Six Sigma, manage root cause analysis, and champion data integrity governance across platforms.

Collaboration with global teams and change management are key aspects of this role. The role involves guiding cross-functional teams, implementing KPI-driven improvements, and ensuring regulatory

Qualifications

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 10+ years in Quality Assurance, Quality Control, Validation or Engineering in pharma.
• Experience with quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review.
• FDA/EMA GMP-regulated environment experience; ISO knowledge preferred.

Responsibilities

• Establishes a Process Excellence/Lean culture within EQ and delivers improvements.
• Owns and executes Root Cause Problem Solving to investigate and solve issues.
• Facilitates complex investigations using advanced techniques and applies statistics to data sets.
• Acts as EQ Data Integrity/Governance SPOC with platform teams to support risk-based planning.
• Defines KPIs to support platform metrics and QMR for projects.
• Owns communication and change management across platforms for specific projects.

Skills

Quality Assurance

Quality Control

Validation

Project management

Lean / Six Sigma

Education

Bachelor's degree in sciences

Master's degree preferred

Tools

Kepner-Tregoe

Value Stream Mapping

Lean

Six Sigma

S/4 HANA

Job description

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.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

Dublin, Ireland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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

The anticipated base pay range for this position is:

€86,400.00 - €148,350.00

Benefits:

• In addition to base pay, we offer the following 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.
• Moreover, we offer 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.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.