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Operations Manager (GMP)
The GMP Operations Manager is responsible for the day to day operations of the b
The role provides daily leadership to the company's facility operations, project
About Our Client
Leading medical device solutions company focused on engineering polymeric solutions that enable medical device technologies and improve quality of life.
The GMP Operations Manager is responsible for the day to day operations of the business. The role provides daily leadership to the company's facility operations, project planning, fulfillment of GMP development and production orders as well as other support functions in compliance with U.S. FDA Regulation 21 CFR Part 210, 211, and Part 820, where applicable. The GMP Operations Manager works collaboratively with business development and quality manager to scope, plan, and execute new business opportunities.
Essential Duties & Responsibilities
· Supervise all facility operations. Accountable for scheduling and execution of all development and production orders.
· Responsible for maintaining facilities and compliance with GMP guidelines and validation.
· Responsible for the training, motivation, discipline, measuring of employee performance and completing staff evaluations.
· Mentor staff to improve their technical competencies and knowledge of GMP operations.
· Provide guidance, advice and support to engineers and other professionals in areas of: project leadership, technical consultation, and documentation, quality, and GMP procedures.
· Compliance with U.S. FDA Regulation 21CFR Part 210, 211, and 820 as well as ISO 13485. Keep current with FDA Regulations, procedures, and policies.
· Maintains safe and clean facility.
· Works closely with customers developing and understanding their requirements, time frame, and funding.
· Support quoting activities through communication of the scope of work required to meet customer objectives.
- Help develop project plans by assisting to specify goals, strategy, scheduling, and identification of risks, contingency plans, and allocation of available resources.
- Responsible to develop annual budget and achieve financial results.
- Performs other duties as directed or assigned.
Supervisory Responsibilities Position is responsible for supervising professional and technical staff.
The Successful Applicant
B.S in Engineering or Science (Plastics Engineering/Chemical Engineering or Materials Science/Chemistry/Biology/Pharmaceutical Sciences) and a minimum of 10 years work experience in a related field; Supervisory experience preferred. Knowledge of pharmaceutical GMP is required. Excellent communication and organization skills with customers, technical staff, and professional staff are a must.
Knowledge of GMP operations, polymer processing, polymer materials or pharmaceutical sciences; U.S. FDA Regulation 21CFR Part 210, 211, and 820. Good negotiation skills, results and action orientation. Demonstrate the ability to incorporate a strategic vision into a tactical application. Self-reliant in determining priorities and setting schedule to meet goals and objectives. Demonstrate senior leadership decision making.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk, talk, and hear. The employee is frequently required to stand for extended periods of time and to use hands to finger, handle and feel. The employee is occasionally required to sit; reach with hands and arms; climb and balance; and stoop, kneel, crouch, or crawl.
What's on Offer