Sr Manufacturing Manager
Job Scope
This role involves leading and overseeing the Manufacturing department. The position ensures that facilities, resources, and equipment are available to meet the business plan. It includes compliance with all cGMP requirements for producing In-Vitro Diagnostic products and implementing operational metrics. The role also involves maintaining and updating procedures, worksheets, and processes to comply with QSR requirements for manufacturing devices. Additionally, it includes scheduling, supporting, and delivering requirements for new product transfer, integrating new process development, validations, and material supply to development teams.
Key Duties and Responsibilities
- Lead and manage supervisory and direct employees in the manufacturing department.
- Ensure work instructions, training requirements, test fixtures, and facilities are compliant (current revision, current calibration, operating within specifications).
- Ensure all activities are performed safely and compliantly.
- Ensure resources (personnel, equipment, facility) are available to support production demand.
- Develop the annual budget for the organization (personnel, tools, capital equipment, facility).
- Monitor job completions to ensure operations costs are captured and allocated timely; analyze budget vs. actual spend monthly, identify/explain variances.
- Collaborate cross-functionally with Materials, Engineering, Planning/Purchasing, Technical Product Management, Technical Support, Order Administration, and other functions as needed.
- Develop and maintain a strong collaborative relationship with Technical Product Management to ensure alignment on emerging trends.
- Collect, analyze, and trend data; prepare and present data/findings/recommendations at periodic management reviews (Quality, Operations Review, and other forums as needed).
- Document investigations (Containment, Corrective Action, Preventative) for issues initiated through internal non-conformances, customer complaints, CAPAs.
- Perform other duties as assigned.
Education, Experience, and Qualifications
- Bachelor's Degree in engineering or a related field required.
- 10+ years of relevant experience in a manufacturing environment within an FDA-regulated industry and/or ISO-certified organization required.
- 8+ years of relevant Manufacturing Operations leadership experience required.
FAQs
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