Remote Manufacturing Quality Engineer Jobs in Boston, MA

37599353 Remote Senior Manager, Clinical Supply Chain 12 Months Contract
Sigma Systems is currently looking for a Senior Manager, Clinical Supply Chain

Responsibilities:

• Responsible for all aspects of supply management inclusive of planning, sourcing, logistics and supplier relations in support of commercial and late-stage clinical products,
• Develop and maintain accurate demand forecasts for pharmaceutical products, incorporating market trends, promotional activities, and regulatory considerations.
• Maintain market intelligence related to areas of responsibility and maintain streamlined and well-understood business processes and systems.
• Collaborate with commercial, marketing, and finance teams to integrate new product launches and lifecycle management into forecasts.
• Monitor forecast accuracy and implement continuous improvement initiatives using advanced analytics.
• Implement data analytics allowing for robust decision making and inputs into various governance forums.
• Create and execute supply plans aligned with demand forecasts, production capacity, and inventory targets
• Identify and mitigate supply risks, including capacity constraints, supplier compliance issues, and regulatory delays.
• Oversee management of suppliers including contract manufacturing as a Strategic Business Relationship Manager; ensure activities are performed per approved supply agreements.
• Oversee financial commitments (work orders, purchase orders, etc.) and legal contracts (Manufacturing Service Agreements, etc.) pursuant to company's delegation of authority matrix.
• Oversee strategic face-to-face and virtual business meetings with contract manufacturing partners.
• Lead cross-functional teams in the management of critical suppliers.
• Engage with Supply Chain key inputs and actions in order to evolve and execute on Product Strategies.
• Process ownership and data-based risk decisions. Escalation to management in an articulate and fact-based manner.
• Lead/Support multiple initiatives related to supply chain management, with focus on systems and processes that support Supply Chain organization (planning software, ERP utilization, product strategy, Logistics, etc.).
• Work closely with R&D (Clinical Operations, Clinical Development, Regulatory Affairs), CMC, Commercial and Quality with focus on supporting commercialization of clinical product candidates.
• Support the Sales & Operations Planning process to ensure coordinated efforts among groups participating in the S&OP process.
• Prepare and actively contribute to Supply Chain Governance forums.
• Pursue/develop cost efficient supply chain systems and processes.
• Support the evaluation of potential suppliers and make appropriate recommendations to management.
• Support global business initiatives for supply chain as required.
• Lead internal efforts to implement best practices throughout the supply and distribution organization.
• Ensure activities and operations are performed compliantly and within budget.

Requirements:

• Bachelor's degree in supply chain management, Business, or a related field required.
• Minimum 8 – 12 years (w/o Masters) or 6 – 8 years (with Master's) of relevant supply chain planning / management experience in biotech or pharmaceutical industry.
• Minimum 3-5 years proficiency in ERP systems, forecasting tools, and advanced Excel.
• Ability to build a collaborative relationship with SMP and other key global partners.
• Experience in strategic global supply chain and supplier relationship management.
• Ability to manage regulatory and technical changes and assess business and financial implications of decisions.
• Strong negotiation skills and demonstrated competence to interact with suppliers, external and internal customers.
• Financial acumen and budgeting experience.
• Effective influencing and communication skills.
• Significant experience in supply chain and distribution management in pharmaceutical or other FDA regulated environment.
• Proficient in ERP software, specializing in end-to-end Planning, Purchasing, and Inventory Management processes.
• Deep understanding of regulatory and technical influences and ability to assess business and financial implications of decisions.
• Strong ability to interact with suppliers, internal customers and upper management in a professional manner.
• Data-driven decision-making and problem-solving.
• Strong oral and written communicator; detail-oriented with a commitment to accuracy.
• Strong knowledge of GMP manufacturing, quality assurance, regulatory affairs, budget planning, financial and commercial operations for biological and small molecule pharmaceuticals.
• Demonstrated ability to lead process improvement activities; delivering business processes and/or technical solutions that satisfy multiple sets of stakeholders.
• Knowledge of and interest in supply chain optimization and simulation.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependence and big picture.