VP of Manufacturing

The Vice President, Manufacturing is responsible for leading all aspects of the Manufacturing activities including company strategy and day to day operations from development through commercial production.

This role will be responsible for the overall operations success of Company’s entire portfolio of products by setting overall direction, ensuring that timelines are met and resources are effectively managed.

This position utilizes Lean Manufacturing and 6-Sigma principles to bring up, maintain, and continually improve in-house production and with our suppliers and contract manufacturers.

In this role, the successful candidate will:

• Oversees manufacturing operations to ensure production efficiency, quality, customer satisfaction and cost effective management of resources.

• Responsible for day to day management of the business to achieve the budgeted operating profit and working capital targets

• Works closely with the senior leadership team to develop, implement, and communicate the operations strategy

• Identifies, recommends, and implements processes (ie.

lead and 6-sigma), technologies, and systems to continuously improve product and service quality as well as operational effectiveness and efficiency

• Develops and implements strategies for manufacturing assembly, designing process flow and implementing control systems.

• Develops and implements a three-year plan in line with the company objectives and to promote revenue, profitability, and growth

• Develops and present performance reports and metrics to the leadership team members

• Manages each phase of manufacturing
– from pilot production and low to high volume manufacturing.

• Oversees all aspects of the site pertaining to waste minimization, yield maximization, labor utilization, and optimization of the business through effective planning.

• Develops comprehensive operating plans and budget requirements that contribute to the achievement of the business and financial goals each year.

• Interfaces with other key areas of business: Engineering, Quality, Marketing, and Finance.

• Establish and implement safety programs in line with company values and policies

• Provides leadership and vision to ensure that development and operational goals are achieved

• Attracts and recruits the brightest, best technical talent and manages and leads them to achieve their maximum potential.

• Develops and leads a culture of learning, respect and employee growth.

Establishes the department’s strategic vision and mentor the manufacturing ops team towards goal achievement.

• Leads by creating a positive environment of open communication and staff development.

• Provides continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement.

• Provides employee recognitions for accomplishments in a thoughtful and timely manner.

• Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks.

• Mentors individuals, based on individual needs, to meet current job expectations and career goals.

• Promotes adaptation and flexibility in a rapidly changing environment.

Acts as a change leader through team building and influence.

Willingness to make difficult or unpopular decisions when warranted.

• Oversees manufacturing incidents and investigations, corrective and preventive actions (CAPA), process variances and deviations.

• Ensures completion of manufacturing change controls, CAPAs, and deviations.

• Ensures that facilities are inspection-ready, including staff compliance with cGMP and all related elements such as documentation (standard operating procedures SOP and validation protocols etc.), training, reports and records.

• Ensures compliance with all appropriate regulatory authorities to include FDA, State of CA, ISO requirements, etc.

• Make decisions, that will at times be difficult and/or unpopular, that support and drive the organization strategy; influences others to support the decisions.

Fosters personal courage in others.

• Ensures plans are in place to meet and exceed goals while providing motivation and inspiration.

• Ensures results are achieved by providing resources, removing obstacles and helping others envision the end result.

• Other duties as assigned.

What does it take to be a qualified candidate

• Seven plus years of successful senior operations management experience in a multi-location manufacturing and distribution environment with strong experience in engineering, manufacturing, operations or related areas.

• Proven ability to develop, implement, and lead successful strategies and tactics to improve operational effectiveness and efficiency (lean management)

• Experience in Lean & Six Sigma methodologies a plus

• Proven ability to build strong, effective relationships with external partners and internal stakeholders

• Possesses leadership qualities and leads a manufacturing team in achieving results in a high-volume manufacturing environment.

• Possesses leadership qualities such as self-awareness, team focus, ability to translate learning into action, and train others to do so, as well as drive success.

• Team player/builder; good coach and able to assist people with adjusting to change.

Must possess a “can-do” attitude.

• Experienced communicator/presenter of technical information with a quality focus to internal as well as external partners.

• Must be well organized and possess excellent organizational skills and the ability to handle multiple areas of responsibility concurrently.

• Must be flexible and adaptable in a fast-paced environment.

• Results and goal oriented; a true professional who can deliver on budget and on time.

• Ability and desire to be proactive not just reactive; a questioning mindset.

• A creative thinker; one who looks for new and innovative ways of doing things

• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC , MHLW MO 169 and TG(MD)R Sch3 preferred.