Director of Production

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
• 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.

Skills & Abilities:

• Strong communication skills, with the ability to communicate effectively with stakeholders at all levels
• Excellent interpersonal and negotiation skills.
• Strong leadership and management skills, with the ability to inspire and motivate teams
• Excellent analytical and problem-solving skills, with the ability to identify opportunities for improvement and implement solutions Ability to work in a fast-paced environment and manage multiple priorities
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• Bachelor's degree in life sciences, finance, operations management, or business field required.
• Master’s degree in life sciences, finance, operations management, or business field preferred.
• 5-10 years of experience in operational management, quality assurance, finance, or relevant cross functional role.