Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.
Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
PRIMARY PURPOSE:
We are seeking an experienced and dynamic General Manager to provide strategic direction and oversee the operations of our healthcare contract manufacturing facility. The ideal candidate will possess a strong background in healthcare manufacturing, exceptional leadership skills, and a proven track record of driving operational excellence and regulatory compliance. This role will assume responsibility for full day-to-day leadership and management to all site operations functions and ensure cross departmental coordination and site operational advancement and goal achievement.
The VP, GM is a strategic leader that can facilitate transformation by providing direction, managing performance, and coaching and building a talented team. Specifically, they will be charged with the mission of accelerating the operational transformation and improving EBITDA. The VP, GM will rigorously focus on operational metrics of Safety, Quality, On-Time-Delivery and Lean transformation "best practices" that will reduce costs and drive margin improvement in all areas of the business, while maximizing customer satisfaction and employee engagement.
MAJOR DUTIES AND RESPONSIBILITIES:
Operational Leadership: Direct and manage all aspects of the facility's operations, including production, quality assurance, supply chain, and maintenance, ensuring alignment with company goals and industry standards.
Strategic Planning: Develop and implement strategic initiatives to enhance production efficiency, optimize resource utilization, and drive continuous improvement in manufacturing processes.
Lead Transformation: Utilize lean principles and skills to create a culture of continuous improvement while driving efficiency and effectiveness in day to day operations.
Regulatory Compliance: Ensure compliance with GMP regulations, FDA requirements, and other relevant industry standards. Lead internal audits and manage regulatory inspections.
Financial/P&L Management: Prepare, review, and approve site manufacturing accounting analysis, including budgetary planning, production efficiency, financial reporting, and capital expenditure submissions. Oversee the facility's budget, financial performance, and cost control measures. Develop financial forecasts and monitor KPIs to ensure profitability.
Team Development: Recruit, train, and mentor a high-performing team. Foster a positive work environment that encourages professional growth and collaboration.
Customer Relations: Build and maintain strong relationships with customers, addressing their needs and ensuring satisfaction with our services. Collaborate with the sales and marketing teams to identify new business opportunities.
Project Management: Oversee the planning and execution of new projects, ensuring timelines and budgets are met while maintaining quality standards.
Risk Management: Identify potential operational risks and implement strategies to mitigate them, ensuring business continuity and safety.
Lean Deployment: Develop, deploy, and maintain lean manufacturing processes using tools such as Value Stream Mapping, 5S, Standard Work, Kanban/Pull-Systems, Root Cause Problem Solving, Lean Daily Management/Gemba Walks, and other continuous improvement tools. Identify, design, implement, and assess programs aimed at improving overall operational performance.
Program Management: Implement and manage programs to ensure the successful achievement of business growth and profit objectives.
Operational Strategy and Execution: Develop strategies and policies aligned with organizational goals to enhance manufacturing performance. Establish short- and long-term manufacturing and site operational goals and objectives. Ensure proper policies and procedures are in place to monitor, measure, and report on actual versus planned performance.
REQUIRED QUALIFICATIONS:
Bachelor's degree in Engineering, Life Sciences, Business Administration, or a related field; MBA preferred.
15+ years of progressive operations leadership roles in a GMP-regulated manufacturing environment, preferably in healthcare or pharmaceuticals, with 5+ years of leading a site.
Track record of effecting change in the organization that drove positive financial results.
Strong knowledge of regulatory compliance, quality assurance, and manufacturing processes.
Proven experience in financial management and operational excellence.
Excellent leadership, performance management, communication, and interpersonal skills.
Ability to work collaboratively with cross-functional teams and drive organizational change.
Proficiency in project management and continuous improvement methodologies (e.g., Lean, Six Sigma).
Strong Microsoft Office Skills to Facilitate Communication and Management
EDUCATION AND TRAINING:
Bachelor's degree in Engineering, Life Sciences, Business Administration, or a related field; MBA preferred.
The ideal candidate will have been trained in a world-class Lean environment with demonstrated success in operational transformation. Examples of enhancing margin through innovative solutions (e.g., new tools, new processes, automation) will distinguish the most compelling candidates. Lean Six Sigma Certification preferred