AD/Director, Head of Supply Chain Tech Services – Alnylam – Cambridge, MA, USA
The Technical Services Head will be the process lead for Value Stream Management establishing the mechanism to drive towards defining and integrating E2E Customer and Product Focused Value Streams. Standard and harmonized processes are built and interact in an integrated way, ensuring agility, reliability and quality for the customer.
This role will drive towards a consistent and Best-In-Class Value Stream/Chain Strategy, Governance, Process, Tools, Standard, System and Measurements to institutionalize Best-In-Class across the segments.
The Leader and his/her team will design and deploy best practices for value including the development of strategic roadmaps, optimization of product portfolio and complexity management.
This leader will be responsible to set the vision and deliver strategy for Global Cold Chain, Artwork Development and Creation of Product Packaging Components. Along with leading the Supply Chain Product Launches, 3 PL Order Fulfillment and Distribution. Global Trade Compliance, including Serialization, will also be a key core competency.
Summary of Key Responsibilities:
COLD CHAIN RESPONSIBILITIES:
- Develops the global strategy for Cold Chain management.
- Evaluates cold chain technologies and trends to implement temperature control best practices.
- Manages suppliers in the development of cold chain products and services. Determines passive/active container solutions in accordance to product temperature profile and considers external factors during transportation and storage (handling, storage conditions, transportation, ambient, transit time, KPI, etc.).
- Develops and implements cold chain solutions in compliance with local and Global regulatory requirements. Knowledge of cold chain requirements FDA, PDMA, 21 CFR, cGMP, HazMat and impact on operations.
- Identifies cold chain risks, impact and critically in order to recommend and execute solutions.
- Develop processes and SOPs and communicates to all parties involved in handling cold chain systems (repacking, recondition, pack out instructions, cold capacity, contingencies, etc).
- Manages the department resources to execute the cold chain projects and support the daily operations. Leads multi functional teams to implement cold chain solutions and projects Globally.
- Establishes the required processes, controls and KPIs to ensure cold chain performance to protect drug substance and drug product in transit to final destination and to drive customer service.
- Responsible for compliance and drive execution of all quality system processes to ensure efficient and effective cold chain operations (deviations, CAPA, change controls).
- Development of all qualified and approved shipping solutions. Training of all Supply Chain platform individuals, internally and externally, on the configuration and execution of GMP cold chain shipping and receiving.
ARTWORK & PACKAGING COMPONENTS RESPONSIBILITIES:
- Implement the Global strategy for Commercial artwork development to support product registration for approved printed components for manufacturing activities.
- Ensures all approved artwork is in compliance with local regulations and requirements to ensure patient safety.
- Develop the organization along with internal and external customers to have a Best-In-Class Artwork Management operations.
- Manages artwork development personnel and resources to support the regulatory filing, supporting the country launches and the execution of the change controls for revision control.
- Develops processes and SOPs for Artwork development and packaging components. Creates and defines roles and responsibilities for group and stakeholders involved in the process.
- Executes the artwork and packaging aspects for new product launch, on market product support and product line extensions with external companies.
- Manages and initiates project tracking updates for revisions and/or new artwork and components. Proactively identifies issues and presents plan for resolution.
- Manages suppliers in the development and supply of approved printed components and artwork development including KPIs. Maintains all relevant specifications and quality information for country specific artwork and packaging components.
- Awareness of industry state of the art technologies for artwork development and packaging/design advancements.
- Collaborates with stakeholders to execute the company quality system (deviations, CAPA, change controls) in order to implement an efficient and effective process.
- Responsible for compliance and drive execution of all quality system processes to ensure efficient and effective artwork development and packaging components process (deviations, CAPA, change controls).
- Is the Subject Matter Expert in Serialization pertaining to Country Specific requirements and regulations.
- Monitor Serialization requirements in the world and implement those requirements to ensure uninterrupted supply worldwide.
3 PL DISTRIBUTION AND SALES ORDER FULFILLMENT:
- Partner and collaborate with Commercial and Finance to ensure all Customer Orders are delivered On-Time, In-Full.
- Partner and collaborate with Legal to ensure all State Licenses are approved, in place for fulfillment.
- Ensure all products are delivered against Sales Order in accordance with the instructions provided by Commercial Operations.
- Timely communication and corrective action for any issues that may prevent the timely delivery to customers.
- Manage and lead team in all GMP requirements of returns, reverse logistics, storage, shipping, receiving and Regulatory audits.
- Manage and lead the country specific requirements for delivery processing from domestic (US) origins to International via procedures and local regulations.
- Responsible for GMP compliance and inspection readiness at all times.
SECONDARY PACKAGING AND LABELING:
- Responsible and accountable for the GMP execution of all secondary Packaging and Labeling at approved and qualified CMOs.
- Developing the packaging production schedule and determining target manufacturing dates.
- Verifying that the materials or components allocated are releasable to the intended regions.
- Partner and collaborate with Quality Assurance regarding authorization to package and label at approved CMO.
- Ensuring all required packaging components are DP are available for the CMO to meet the packaging plan.
- Key stakeholder and alliance management with CMO. Conduct monthly business reviews and ensure robust performance metrics are tracked and communicated.
- Ensure all Serialization procedures are developed, validated, commissioned and executed to ensure Global continuity of supply to patients.
- Ensure all sub-contractor purchase orders are developed, delivered and executed according to SOPs governing batch record requirements.
- Develop, implement and manage process to support market introduction (product launch) of Alnylam products globally.
- Partner and collaborate with a cross function group to ensure products can be launched globally. Including SME engagement (development team, commercial manufacturing, QA, RA, QC, SC, etc), understanding technical requirements and engaging SMEs as necessary to support overall launch.
- Partner and collaborate with Commercial and Finance on the prioritization of product launches and balance launch schedule to meet patient needs and company goals as appropriate.
- Develop appropriate strategies for supplying commercial sale product to Ministry of Health as well as private distributors weighing supply risks, resource utilization, cost, regulatory risks. Consolidating and communicating changes related to regulatory updates for product packaging
- Risk management: capturing supply chain risks and issues that can jeopardize product supply to customers, such as regulatory constraints and deadlines, costs and inventory planning requirements.
- Launch and lead project implementation teams by establishing project deliverables, tasks, schedules, resources and priorities.
- Engage with appropriate CMOs to support developed plans to support overall product launch for specific market(s).
To qualify for this role, one must have an Undergraduate degree in business, science or supply chain disciplines.
Approximately 10-15 years of experience in biotech or pharmaceutical industry with a successful and robust skill-set of Supply Chain, Product Launches and GMP operations. A strong understanding of Quality Systems and procedures.
Successful track record of successfully delivering supply chain/value chain improvements.
High level of leadership of teams, processes, including multi-layer management.
Strong working knowledge of Ministry of Health Country Requirements.
Strong communication, organizational and customer service skills,
Strong attention to detail and follow through.
Ability to develop SOPs and interact with government compliance agencies.
Robust and strong experience with multi-country regulatory PAI, audits and inspections.