Purpose:
The Director of Production is responsible for overseeing all production staff and all production activities to ensure continuity of production to support organizational goals.
Duties & Responsibilities:
Direct and oversee the manufacture of products, ensuring production, performance, and quality standards are consistently met in accordance with established procedures and in alignment with the organizational strategy and goals.
Provide business after-hours or on-call support remotely or on-site as needed for production support, environmental monitoring alarms, personnel issues, and/or emergency events.
Oversee management of production schedule to support distribution/sales forecasts,.
Establish production metrics and provide routing reporting to executive management.
Plan, direct, and coordinate lean process improvement initiatives.
Organize and maintain department structure and teams for optimal, efficient operations.
Support development of management structures for operational support departments.
Direct and oversee department training program for new employee onboarding.
Support executive management with long-term operating goals, expansion efforts, and implementation of new technology.
Drive department accountability for quality and efficiency.
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
Author, revise, and maintain procedures in accordance with FDA, AATB, and other regulations (as appropriate).
Oversee management of equipment qualification plan development.
Review and approve equipment and process validation/verification/qualification protocols, execution data, and summary reports in accordance with FDA, AATB, and other regulations (as appropriate).
Collaborate with Product Development/Management to establish/support project timelines.
Plan, direct, and drive implementation of new production processes in collaboration with Product Development, Quality Assurance, and Regulatory Affairs.
Integrate shared leadership and foster collaboration across multi-disciplinary teams.
File and maintain records in accordance with standard operating procedures.
Support internal and external audits.
Develop and maintain relationships with key stakeholders, including vendors, customers, and employees.
Participate in proposal presentations and face-to-face interactions with clients and customers.
Develop and implement department budget.
Establish and monitor objective annual goals for direct reports.
Provide constructive feedback and guidance to develop leadership in direct reports and department management.
Conduct performance reviews and establish performance improvement plans as needed.
Recruit, interview, and select personnel for hire.
Travel domestically up to 15% to attend offsite meetings, conferences, and support business initiatives.
Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
Perform other related duties as assigned.
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