A nationwide medical manufacturing company is seeking a Senior Manager of Operations to join their team in Mebane, NC. This role reports directly to the Plant Manager and oversees the effective utilization of manufacturing, packaging, warehouse, and material handling labor to achieve plant objectives in line with business goals. The Senior Manager is responsible for ensuring Safety, Quality, Delivery, and Financial performance, driving organizational growth through Lean initiatives, and promoting continuous improvement efforts.
Key Responsibilities:
- Lead and support all aspects of site operations, including production, quality assurance, regulatory compliance, safety, environmental practices, maintenance, engineering, and training.
- Assist in maintaining or achieving ISO 13485 certification at the site.
- Ensure the facility's FDA registration is up to date.
- Manage local regulatory requirements and ensure the proper licenses are maintained.
- Develop and implement procedures for the safe storage, handling, and disposal of hazardous waste.
- Foster a positive work environment, promote teamwork, and drive continuous improvement.
- Oversee relationships with external vendors providing services at the site.
- Serve as a member of the Corporate Emergency Response Team (CERT).
- Design and execute effective employee relations strategies.
- Ensure compliance with proper documentation practices at the site.
Qualifications:
- Bachelor's degree required.
- Prior experience managing a manufacturing operation is preferred.
- Willingness to travel domestically and internationally (25%-50% of the time).
- Strong interpersonal, decision-making, and leadership skills.
- Excellent communication and presentation abilities.
- Proven track record in leading change management efforts.
- Proficient in Microsoft Office Suite.
- Lean Six Sigma Green Belt certification would be ideal
- Knowledge of FDA regulations and GxP guidelines.
- Experience in a LEAN manufacturing environment would be ideal
- Familiarity with Good Documentation Practices.
- Understanding of basic OSHA regulations.
- Experience with SAP software or training.
- Project management skills.
Salary Range:
$130,000 - $150,000 + bonuses and stock