POSITION SUMMARY:

The Senior Director, Laboratory Operations is responsible for developing, planning, implementing, monitoring, and improving processes  for new or existing products across multiple labs and locations to meet corporate goals. Works closely with quality groups including the accountable Clinical Laboratory Director to ensure strict compliance with approved policies and procedures at all times. Ensures the effective use of materials, equipment, and employees in producing quality products. Develops, monitors, and controls budgets for labor and capital expenditures. Formulates and champions clinical testing policies, procedures, and programs to achieve quality, cost, revenue, and margin goals. 

PRIMARY RESPONSIBILITIES:

• Reporting to the Vice President Laboratory Operations, this individual develops and provides strategy, vision and direction in close collaboration with other Laboratory Operations leaders.
• Responsible for championing operational needs and inspiring cross departmental support for implementation of simultaneous initiatives to improve quality, capacity, Turn Around Time (TAT), and COGS.
• Acts as the primary contact for delegated products, builds effective partnerships, and communicates succinct updates with departmental heads to help drive the business towards achieving company objectives.
• Responsible for contributing to budget preparation, monitoring of revenue, expenses, test volume, FTE utilization, report/result turnaround, as well as overall workflow, and customer and employee satisfaction.
• Leads, directs, and manages high performing teams with accountability for customer satisfaction of assigned departments and products.
• Oversees the development and achievement of departmental key performance indicators (KPI) through optimizing departmental performance and communicates effectively with key stakeholders
• Serves as a visible role model to drive continuous improvement, implements effective change management in support of changes, delegates work, and builds a strong leadership bench.
• Fosters a positive work environment by utilizing employment policies and procedures, awards, and other opportunities within the company.  Serve as a role model for standards of behavior and performance.
• Ensures subordinate development through professional development reviews, coaching, mentoring and training. Collaborates with direct reports to create professional development goals for their team.
• Interacts with executive level management to influence internal and external policy-making.
• Responsible for representing the company during audits, visits, technical calls, and client visits.

QUALIFICATIONS:

• BS/BA degree (or equivalent) in STEM related field; Biological Sciences preferred
• A combination of education and experience equivalent to: Bachelor degree (BS) and 12+ years’ experience; Master’s degree (MS) and 10+ years’ experience; PhD and 7+ years’ experience.
• 5 plus years’ experience overseeing manufacturing at a Director or Senior Manager level
• Ability to travel up to 25%
• Current California CLS license or CGMBS license (Clinical Genetics Molecular Biology Scientist) preferred

KNOWLEDGE,SKILLS AND ABILITIES:

• Proven track record in successfully maintaining Quality program procedures, ISO 13485 standard, experience highly preferred
• Working knowledge of FDA requirements as per 42 CFR 493 (CLIA) and 21 CFR 820 (QSR)
• Working knowledge of Good Documentation Practices (GDP), and Good Clinical Practices (GCP) / Good Manufacturing Practices (cGMP), preferred
• Experience handling product/process nonconformities, audit corrective actions, and CAPAs.
• Excellent computer skills, including Microsoft Office Suite (especially Excel)
• Excellent communication skills with managers, subordinates, and colleagues with a proven track record to influence change (written and oral)
• Exceptional level of organization, time management, problem solving, self-motivation and reliability
• Experience in building and managing a high performing group of engaged and motivated employees
• Track record of providing succinct, timely, and thorough program updates to leadership
• Knowledge and experience with Lean Six Sigma concept and tools, manufacturing/Engineering experience, and LDT laboratory operations required.