Senior Director of Manufacturing

Organization: 
Cepheid - US
Job Location: 
Sunnyvale, CA
Job Description: 

The Senior Director of Manufacturing is responsible for directing the development and implementation all activities related to Manufacturing and develop departmental goals based upon corporate objectives. The primary objectives are to direct the Manufacturing Department, so that quality products are manufactured on time and at or below budgeted costs, while adhering to all appropriate regulatory requirements.

Prioritize production schedules based on product introduction, equipment efficiency, and materials supply. Plan and administer procedures and budgets. Develop financial and resource budgeting for departments and, at higher levels, control capital expenditures and direct/indirect labor. Overall responsibility and accountability for regulatory compliance in Manufacturing.

- Responsible for meeting production requirements, yield and cost standards, through managers and supervisors. Assist in assuring that products are manufactured according to cGMP.
- Responsible for ensuring that processes, equipment and the facility meet applicable Quality and Regulatory requirements.
- Develop the Production plan with the Planning group, and establish procedures for maintaining high quality standards to ensure that products conform to established customer and Company quality standards.
- Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
- Ensure that organization structure, resources, facilities and capital equipment are available to meet long-term production forecasts.
- Represent the Manufacturing Department on multi-disciplinary teams and committees, such as MRB. Empowered to commit resources and recommend changes on behalf of Manufacturing.
- Provide leadership and strategy in the hiring, development, motivation and performance review for the department, including empowering managers and supervisors to make decisions and initiate actions.
- Responsible for maintaining an environment where employees take individual responsibility for sustainable safety and quality in all aspects of their job.
- Active champion of productivity improvement efforts to deliver future company goals.
- Work on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
- Communicate the company vision and culture through words and actions, models company values.

- Bachelor's degree or equivalent combination of education and experience to perform at this level.
- 10+ years previous management experience, preferably in a commercial GMP Manufacturing environment, is required.
- 5+ years experience in medical device, diagnostic, or other related industry is required.
- Must have experience working with automation line for high volume production.
- Strong ability to identify and trend data to formulate actionable plans and deliverables.
- Must understand the business model and its strategic implications, directing the manufacturing effort accordingly.
- Must have experience assuming ownership for significant product responsibilities and manufacturing processes.
- Thorough understanding of manufacturing cost methods/models required.
- Thorough understanding of operation of clean rooms, Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to effectively present information to top management, clients, customers, and the general public, and/or boards of directors.
- Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.

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