Job Description

Location: Raleigh, NC

Salary: $130/k - $140/k

DIRECT HIRE

SUMMARY

The Production Manager determines and directs operations of production areas to ensure volume, costs, waste, and quality standards are achieved. Operations directly managed include the visual inspection process and the packaging process of vials and syringes. The Production Manager ensures that all company policies are enforced at all times, leads the production team as a role model by exhibiting professional behaviors, and fosters a culture of integrity, excellence, collaboration, and accountability.

Essential Functions & Responsibilities:

• Ensures operational tasks are performed in a manner which aligns with the Company's Quality System, Safety and Environmental Management System, and all governing regulatory bodies in the U.S. and Internationally.
• Partners with quality leadership to ensure cGMP practices and their implementation in manufacturing.
• Monitors weekly schedules through interface with Planning and Logistics, ensuring timely customer service.
• Resolves in a timely manner escalated issues that arise from operations and that require coordination with other departments.
• Lead and/or support all investigations, manufacturing exceptions, product failures, RCA and customer complaints at the appropriate level with complete and comprehensive detail.
• Monitors shift production metrics to identify and resolve issues and develop process improvements.
• Create and manage department budget and implement strategies to ensure cost-effective production.
• Ensures all employees within the area are properly trained in areas directly related to their job responsibilities as well as per company policies, quality policies, and safety/environmental policies.
• Conduct departmental and skip level meetings with employees.
• Set clear vision by ensuring goals and objectives are aligned with site strategies through performance management and identify and implement career development plans for direct reports.
• Coaches supervisors in best practices to provide a safe and efficient work environment and resolve production problems.
• Drive Continuous Improvement philosophy and practices.
• Responsible for all special projects assigned by the Plant Director, to include but not limited to Lean Manufacturing initiatives, six sigma projects, safety initiatives, etc.
• Liaise with different departments, including suppliers, finance, and others to align production with market needs and company goals.
• Provides input to strategic decisions that affect the functional area of responsibility.

Education and Experience Requirements:

• Bachelor's Degree required in Manufacturing, Engineering, Science, Business, or related field.
• MBA preferred.
• 5+ years of manufacturing operations experience, preferably in cGMP environment.
• 5+ years of supervisory/leadership experience required.
• Knowledge of FDA and cGMP regulations and requirements.
• Six Sigma or Lean Manufacturing Certification a plus.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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