Responsible for the timely and in-full execution of production plans
Ensures compliance to cGMP standards, internal procedures and product quality standards
Works cooperatively with all functional areas of the business to facilitate innovation while ensuring the delivery of products and services of the highest quality and compliance
Liaison with all relevant regulatory bodies including the FDA and State Boards of Pharmacy
Works cross functionally to facilitate product registrations, field actions/recall management, product life cycle management and asset management in line with business objectives
Delivers service levels in line with customer and company expectations
Accurate and focused management of budgeted expenses
Fosters a continuous process improvement environment
Leads 3-5 direct reports across the Manufacturing (Formulation, Filling, Sanitization) & VILP groups
Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration
Conduct regular 1:1’s to address performance, feedback and relationship building
Identify training and development needs within the team and facilitate as able
Requirements
Bachelor’s degree in engineering, science or related discipline required
Master’s degree preferred
7+ years in related Manufacturing Operations required
5+ years in a significant managerial role preferred
Demonstrated knowledge of cGMP guidelines/standards is required
Working knowledge of Lean Manufacturing/6 Sigma principles
Comprehends standard operating procedures, forms, training, and quality control activities
High integrity, good judgment, in a matrixed environment
Excellent organizational skills
Strong hands-on, “roll up your sleeves” attitude, with emphasis on achieving results
Ability to think strategically and execute on strategy
Strong experience in project and budget management
Excellent people management, analytical and problem-solving skills
Demonstrated written and oral communications skills including strong presentation skills
Proficient written, verbal and oral English communication skills are required
Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel
Benefits
Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
Flexible Spending & Health Savings Accounts (FSA & HSA) available
Dental & Vision insurance
Employer Paid Life Insurance & Employee Assistance Program
Short Term & Long-Term Disability Insurance
Up to 4% 401K Matching (100% vested on day one!)
Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
$5,250 Annual Tuition Reimbursement after 6 months