Director of Production

Position Title: Director of Production
Department: Production
Reports To: Vice President & General Manager
Job Type: Full Time
Shift: Monday - Friday 08:00 AM - 05:00 PM
Exempt / Non-Exempt: Exempt

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.
  • Manage direct reports.
  • 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.