The ideal candidate is a highly analytical leader responsible for overseeing the CGMP compliance, facility management, supply chain, and process engineering for Wilcrest Pharmaceuticals. This role requires a strategic leader who can ensure that all operations and technologies align with FDA regulations & guidelines, industry best practices, and company policies. This position requires face-to-face interactions with customers, regulatory inspectors, fellow employees, vendors, etc.
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
