Operations Director

7 hours ago


Houston, Texas, United States Wilcrest Pharma Full time
Director of Operations

The ideal candidate is a strategic leader responsible for overseeing the CGMP compliance, facility management, supply chain, and process engineering for Wilcrest Pharmaceuticals. This role requires a highly analytical leader who can ensure that all operations and technologies align with FDA regulations & guidelines, industry best practices, and company policies.

Key Responsibilities:

  • Develop and implement operational systems that meet CGMP requirements and optimize production efficiency and safety
  • Provide scientific and business leadership to ensure assigned departments meet the expectations of customers and business goals in terms of cost, quality, and turnaround time
  • Analyze key metrics to drive process improvements and ensure quality product output
  • Collaborate with executive management to set strategic goals and align operations with company objectives
  • Oversee facility maintenance, ensuring a safe and compliant work environment
  • Direct development, implementation and optimization of ERP system
  • Manage process engineering initiatives to enhance production capabilities and scalability
  • Support quality assurance efforts to maintain product integrity and customer satisfaction
  • Manage and administer supply planning and purchasing, warehousing, inventory control logistics, and pharmaceutical packaging
  • Ensure compliance with all relevant FDA, DEA, and state regulations and guidelines
  • Recruit, train, and mentor operations staff to build a high-performing team
  • Coordinate with cross-functional teams to support new product launches and facility expansions

Qualifications:

  • Bachelor's degree in Business, Operations, Supply Chain, Engineering, Science or related field; Master's degree preferred
  • Minimum of 5 years of experience in pharmaceutical manufacturing (sterile manufacturing experience preferred)
  • Minimum of 3 years management experience
  • Proven track record of managing operations in a CGMP-regulated environment
  • Strong leadership skills with the ability to motivate and guide a team, and partner with cross functional team members
  • Excellent communication, organizational, and problem-solving abilities
  • Knowledge of FDA regulations pertaining to 503B outsourcing facilities
  • Experience with process improvement methodologies such as Lean or Six Sigma


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