The primary purpose of the Director, Operations position is to direct and manage operations and manufacturing team’s execution on overall activities to ensure best practice while identifying problem areas and taking corrective actions. We are looking for someone with exceptional leadership capabilities to lead large functional teams to deliver against their goals.
Essential Duties and Responsibilities (other duties may be assigned):
- Provides leadership for the Operations team – Manufacturing and Production.
- Leads the development of the consolidated strategy, and annual operating plans and operational/capital budgets across Operations.
- Work with senior management in formulating and administering company policies and developing long-range business goals, objectives and growth.
- Achieve significant and sustainable improvement in operating costs, product costs, product quality and process development.
- Ensure implementation of Standard Work Processes, Quality Assurance and Control Processes.
- Own and be accountable for Operations performance metrics for production, order fulfillment and product launches.
- Planning and Management of forecasts with manufacturing resources and capacities.
- Mentor and develop associates in best practice in manufacturing, customer support and information technology.
- Direct and coordinates activities of respective departments for which responsibility is delegated to further attainment of business goals and objectives.
- Reviews analyses of activities, costs, operations, and forecast data to determine department or division progress toward stated goals and objectives.
- Collaborate with the leadership team to review achievements and discuss required changes in goals or objectives resulting from current status and conditions.
- Ensure compliance with all company and government regulations, policies and procedures are followed according to local, State and Federal laws.
- Oversee the prioritization and progress on key initiatives and the consolidation of goals and key management and operational processes.
- Works collaboratively with marketing, sales and product delivery to align operational capabilities with short/long term customer needs and ensure that effective supply chain processes are in place.
- Ensures that departments are structured and staffed to support the continuing growth of the business both through internal and external organic growth.
- Formulates and recommends operations, manufacturing and development policies and programs.
- Provides leadership, communication, and coaching to employees; cultivates a safe environment of trust, teamwork and accountability.
- In collaboration with other functions at the site, is responsible for defining, implementing, and sustaining a continuous improvement culture.
- Accountable for the supply of high-quality products, ensuring availability to BioGX’s customers around the world.
- Accountable for financial performance of product operations; drives organization to identify and implement cost savings improvements that result in a continuously declining product standard cost.
- Continuously assesses the current and future talent needs, assessing gaps, and ensures a robust talent pipeline through both internal people development and external recruitment.
- Assesses current and future capacity needs and ensures the necessary resources and in place when that capacity is needed.
- Manages performance of staff towards department and company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
- Demonstrates commitment to the development, implementation and effectiveness of BioGX’s Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of responsibilities and duties. Has awareness of device defects and impacts.
- Collaborate with departments, and external partners to ensure adequate and timely delivery of agreed services, in line with agreed service levels.
- Provides insight to the business unit on how to best develop and leverage Supplier capabilities for the organization(s).
- Solves complex problems, takes a broad perspective to identify solutions
- Leads change and innovation. Stimulates creativity and innovation in others. Open to new ideas.
- Will respond to onsite emergency calls as needed.
- Perform other duties & projects as assigned.
Supervisory Responsibilities: Direct senior production staff, senior manufacturing staff, team leaders, manufacturing and production staffs in order to achieve company objectives and departmental goals. Manage staff growth and development.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Experience in CGMP for medical devices manufacturing and production of reagents
- Experienced manager coming from medical device ISO 13485 or IVD related business with strong knowledge of manufacturing environment, manufacturing controls and effectiveness
- Demonstrate proven ability to think strategically along with the business acumen and experience to appreciate and anticipate the short and long-term implications of operating decisions.
- Excellent communication skills, including the ability to speak and write clearly and succinctly in a variety of communication settings and styles.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
- Analytical problem solving and fact finding skills
- Ability to identify, clarify and resolve project activity issues and risks as needed
- Ability to gather and communicate meaningful operational metrics (employee workload, system utilization, system uptime, deployment times, etc).
- The ability to provide leadership, direction, team building, coaching, and decision-making with employees and peers
- Prior vendor management experience.
- Understanding of key financial and operational drivers
- Ability to concisely communicate status, needs, forecasts, risks and timelines effectively to executive team
- Knowledge and experience deploying lean manufacturing principles and operational excellence
- Ability to work at site and global level. Must understand the complexity of the business and be able to navigate and communicate effectively within a matrix structure.
- Experience leading multiple complex projects.
- Has experience in working in high performance organizations and has a proven track record of developing high performing teams.
Education and Experience:
- BS/BA degree with a minimum of 10-12 year’s management/leadership experience in the cGMP FDA/healthcare-manufacturing environment
- 5+ years experience in lean six sigma, Kaizen, continuous improvement strategies, program and project management experience, including estimating and forecasting, budget and financial management, staffing / hiring and resource management
- Previous experience of working in a high-volume, fast paced manufacturing environment
- Direct hands-on interactions with FDA and other regulatory agencies
- Executes the negotiation of all logistics contracts.
Pay: From $90,000.00 per year
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off