Director Supply Chain Operations – Sequoia – San Diego, CA, USA
The Supply Chain Operations Director will provide leadership to support Materials Management personnel in meeting requirements for all Client orders, Clinical Study requirements and future commercial activities for a cell therapy production facility. This position is responsible to provide both strategic direction and leadership for a broad range of operations and supply chain activities such as procurement, production planning, inventory management, logistics, and warehousing supporting cGMP and Research & Development functions. Develop and apply innovative practices to business challenges and to advance the organizational goals as a strategic partner.
Essential Duties and Responsibilities
- Develop strategy for creating best practice processes and a supply chain infrastructure that scales from a clinical trial / R&D organization toward a commercial platform.
- Lead cross functional teams (S&OP meeting) to ensure alignment of capacity to customer demand.
- Align the Materials Management team around the growth strategy while optimizing production improvement including quality, productivity, pricing, capacity, and time to market.
- Drive process improvements, innovation, and product related cost reductions.
- Develop and establish industry-compliant and business appropriate part number and material classification system.
- Initiate and execute streamlined material fulfillment processes for materials required for both GMP and non-GMP functional areas.
- Oversee Materials Management team; ensure compliance to company procedures and industry regulations.
- Lead the design, implementation and/or development of improvements for the ERP system.
- Evaluate materials and operational work flow, establish performance metrics, and lead efforts to maximize efficiency, quality and capacity utilization.
- Report on Key Performance Indicators such as forecast accuracy, inventory levels, inventory reserve, months of supply, and customer delivery performance.
- Oversee activities related to vendor relationships; negotiate with suppliers to minimize material and transportation costs.
- Participate in resolution of non-conformances; resolve recurring problems with permanent solutions.
- Develop and manage supply chains for all phases of clinical trials and client demands; develop supply chain management procedures and process workflows.
- Manage clinical supply inventory and develop process for preparing/tracking clinical supply kits.
- Partner with Clinical Operations to understand and fulfill clinical supply demands.
- Leverage cold chain expertise to guide selection of shippers, couriers and shipping lanes.
- Participate as a key member of the Management Team; attend weekly management meetings and provide updates and/or input on issues.
- Ensure compliance with all internal finance policies/ procedures including SOX requirements.
- Ensure Supply Chain function is fully prepared for both internal and external audits.Provide support to quality management in the preparation for, conduct of, and follow-up activities associated with site visits from clients and regulatory/accrediting agencies.
- Lead, participate in or facilitate interdepartmental project teams, as required. Qualifications
- 10+ years of experience in supply management/logistics in biotech/pharmaceutical industry
- Management experience of 8 years or more; prefer Director level experience of 3 years or more.
- Exercise independent judgment, analytical and problem solving skills in order to resolve issues in a timely and efficient manner. Anticipate and defuse any potential problems.
- Proficient in cGMP’s, pharmaceutical industry procedures, FDA and EMEA regulations (21CFR 211)
- Experience with international logistics for distribution outside of U.S.A. (e.g. Canada, Europe, Asia and Mexico)
- Strong ERP development experience required to provide insight for ERP design and implementation
- Ability to manage several projects simultaneously to quality, budget and schedule constraints
- Capable of assembling project budgets
- Proven ability to work in cross functional teams to execute projects and
- Strong interpersonal skills and the ability to create and lead a successful team
- Excellent problem-solving and decision-making skills
- Flexibility and the ability to manage change
- Exceptional verbal and written communication skills,
- Strong organizational, time management and project management skills
- Demonstrated ability for analytical and systematic thinking
- Must be competent with the Microsoft Office suite of products
- Ability to solve practical problems and deal with a variety of variables in situations
- Ability to identify strategies to address complex quality issues
- Bachelor’s degree (BS) in Materials Management, Supply Chain or a related discipline
APICS or CSCP Certifications preferred
- May occasionally work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing.
- May occasionally be exposed to fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals and/or extreme cold.
- The noise level in the work environment is usually moderate with background sounds from instruments and/or equipment in the laboratory. Noise level at other sites during audit function may fluctuate.
- Must be able to occasionally lift and carry items weighing up to 25 lbs.
- Must be able to walk around facility. Regularly required to sit, stand, walk, reach with arms, climb, balance, stoop, kneel, and crouch.