Senior Manager, External Quality Business Processes and Strategic Projects

Biopharma Asia; Zug; Remote; CHF 140,000 - 210,000; Full time

Job summary

Biopharma Asia seeks a Senior Manager for External Quality Business Processes and Strategic Projects to lead process improvements and governance across EQ. You will drive Lean initiatives, establish data integrity frameworks, and coordinate cross-functional global teams to standardize processes and support system implementations.

Requires a strong background in GMP-regulated pharma environments, RCM, and project leadership with a focus on patient safety and quality.

Qualifications

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 10+ years of combined experience in Quality Assurance, Quality Control, Validation or Engineering in the pharmaceutical industry.
• Working knowledge of quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review.
• Proven knowledge of applicable Data Integrity regulations.
• Experience in FDA/EMA GMP-regulated environments and familiarity with ISO requirements.

Responsibilities

• Establish a Process Excellence/Lean culture within EQ using methodologies like Lean, Value Stream Mapping to identify and deliver improvements.
• Owns and executes the Root Cause Problem Solving process to investigate issues.
• Facilitates complex investigations using advanced methods and applies statistical analysis to data sets.
• Acts as EQ Data Integrity/Governance SPOC: design and implement the framework and drive gap remediation across platforms.
• Ensures cross-functional alignment and risk-based resource planning.
• Defines and collects KPIs to support platform metrics and project portfolios.
• Owns communications and change management across platforms and supports S/4 HANA adoption.

Skills

BPM

Compliance

Data Integrity

Cross-Functional Collaboration

Fact-Based Decision Making

Stakeholder Engagement

Lead Projects

Education

Bachelor’s degree in sciences

Master’s degree preferred

Tools

ISO 9001

GMP

Job description

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Zug, Switzerland

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.

Required Skills:

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