Sr Specialist Product Change Management & Implementation (m/f/d)

Join Our Team as a Senior Specialist in Product Change Management & Implementation

Role Description

The Senior Specialist - Product Change Management & Implementation will support the Lead of the department in ensuring compliance with regulatory requirements and executing strategies for managing international (ex-US) post-approval changes within the pharmaceutical supply chain.

The senior specialist will collaborate with various departments, including Human Health, Supply Planning, Demand Management, SC Fulfillment, Market Planning, internal/external manufacturing sites, Regulatory Affairs, Global Artwork, Serialization, Master Data, Finance, Global Logistics, and Quality. This role requires a strong understanding of regulatory frameworks, attention to detail, and the ability to work collaboratively with cross-functional teams.

Responsibilities

• Lead cross-functional projects, manage complex information flow, and coordinate the functional/tactical project management activities for Network Changes and Regulatory driven changes with Artwork impact, in close collaboration with Value Chain Management, Product Source Management, Planners, other Supply Chain functions, and stakeholders across divisions.
• Coordinate activities to mitigate risks related to the different milestones across the SKU change management and implementation stages, including Code Creation, Initial RCT update, Forecast Positioning, Artwork Readiness, First Packaging/Pack-by Readiness, and last packaging, ensuring system readiness for successful post-approval change execution.
• Provide end-to-end visibility for all projects within the assigned product portfolio to all stakeholders throughout all divisions.
• Coordinate activities to mitigate risks related to Artwork Readiness, liaising with Regulatory Affairs, Artwork Centers, and Quality for timely execution.
• Drive process improvement initiatives as needed.
• Implement, track, and report KPIs to mitigate risks and minimize business impact; participate and provide input to the IBP process (Demand Reviews, Site Supply Reviews).
• Understand and translate packaging lead times, capacity issues, process reliability issues, sourcing flows, market-specific requirements (e.g., TOI, shelf-life requirements), and regulatory issues impacting supply into appropriate risk mitigation actions.

Change Management Execution

• Assist in the development and implementation of strategies for managing post-approval regulatory changes in the supply chain.
• Collaborate with cross-functional teams to assess the impact of regulatory changes on the supply chain.
• Support the execution of change control processes and procedures to ensure compliance with regulatory requirements.
• Contribute to the implementation of post-approval change initiatives, including risk assessment and mitigation strategies.

Network & Source Changes

• Ensure early engagement with Product Source Management for robust implementation of source of supply changes by translating existing source change projects into tangible supply chain system readiness milestones while minimizing impact on service and cost.
• Identify scope of change and analyze impact on resource planning.
• Assess and influence target dates from an end-to-end perspective.

Regulatory Driven Artwork Changes

• Coordinate and track Artwork Milestones.
• Track and report on initiatives and projects in the overall portfolio using information available in regulatory tools.
• Work with project leads to use process toolsets to construct, deploy, and maintain methodologies for managing large-scale initiatives/projects, including Serialization, Corporate initiatives, and Divestitures.
• Execute phase in/phase out of SKUs related to material proliferations required due to regulatory requirements, serialization, or harmonization.
• Manage the Last Authorized Shipping Date Process for the assigned product portfolio.

Regulatory Compliance Support

• Monitor global regulatory requirements related to post-approval changes in the pharmaceutical industry.
• Analyze and interpret regulatory guidelines to assess their impact on the supply chain.
• Provide support and recommendations to internal stakeholders regarding compliance matters.

Project Support

• Manage projects related to regulatory change management and implementation.
• Support resource coordination, timeline tracking, and deliverable completion.
• Identify and report project risks and propose solutions.

Data Analysis

• Collect, analyze, and summarize data to support decision-making and project evaluation.
• Prepare reports and presentations on SKU change status, milestones, and key findings.

Cross-Functional Collaboration

• Collaborate with regulatory affairs, quality assurance, manufacturing, logistics, and other relevant departments to support the implementation of regulatory changes.
• Support the assessment and resolution of post-approval changes' impact on product quality, supply, and distribution.
• Foster collaboration and communication across cross-functional teams.

Documentation and Reporting

• Maintain accurate and up-to-date records of post-approval regulatory changes in the supply chain.
• Prepare reports and documentation for regulatory agencies, internal audits, and senior management.
• Ensure proper documentation and archiving of regulatory filings, correspondence, and other relevant documents.

Professional Education and Skills

• Bachelor's degree in biopharmaceutical supply chain, regulatory affairs, or a related field.
• 3 to 5 years of relevant experience in regulatory affairs, supply chain management, or a related field within the pharmaceutical industry.
• Strong knowledge of global regulatory frameworks and guidelines related to post-approval changes in the pharmaceutical supply chain.
• Attention to detail and ability to analyze and interpret regulatory guidelines.
• Good communication and interpersonal skills to collaborate with cross-functional teams.
• Ability to work both independently and as part of a team.
• Familiarity with regulatory information management systems and document control processes.
• Proficient in the use of business software (including MS Excel, MS PowerPoint, MS PowerBI, MS Apps).

The Company

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.

Required Skills

• Adaptability
• Analytical Thinking
• APICS CPIM
• Biopharmaceutical Industry
• Budgeting
• Change Control Management
• Change Control Processes
• Data Analysis
• Demand Forecasting
• Detail-Oriented
• Inventory Management
• Logistics Management
• Manufacturing Compliance
• Microsoft PowerPoint
• Mitigated Risks
• Order Management
• Personal Initiative
• Process Improvement Projects
• Process Improvements
• Production Scheduling
• Regulatory Affairs Compliance
• Regulatory Change Management
• Regulatory Compliance
• Regulatory Frameworks