Job Description: Senior Manufactoring Manager
Position Overview:
This role is responsible for managing and executing total quality management systems within the External Supply organization, focusing on Raw Materials Categories, Devices, and Contract Manufacturing.
Key Responsibilities:
- Execute activities related to nonconformance, CAPA, SICAR, Change Control, and metrics oversight.
- Act as the category owner for quality records and procedures.
- Process and investigate deviations as first responders, ensuring timely resolution under the company's quality management system procedures and compliance with regulatory agencies.
- Monitor deviations, investigate root causes, and determine corrective and preventive actions to address trends or modify existing manufacturing or packaging processes.
- Maintain unified product defect investigation operating procedures and provide technical expertise to optimize deviation management and prevent recurrence.
- Ensure systems are in place for thorough investigation and timely conclusion of all deviations per company quality standards.
- Communicate across all organizational levels, facilitate solutions for critical business issues, and define objectives to enable effective metric generation and reporting.
- Serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials.
- Assist in developing workforce model criteria to support department needs and business initiatives.
Basic Qualifications:
- Master's degree and 6 years of Quality and/or Manufacturing experience
- Bachelor's degree and 8 years of Quality and/or Manufacturing experience
- Associate's degree and 10 years of Quality and/or Manufacturing experience
Preferred Qualifications:
- 6+ years of related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry.
- Demonstrated experience with compliance, problem-solving, advanced root cause analysis, critical thinking, project management, and quality systems.
- Understanding of quality management systems and quality control processes related to raw materials in clinical and commercial operations.
- In-depth knowledge of EU and US cGMP regulations.
- Ability to work with minimal supervision, present data effectively, and communicate clearly.
- Proven ability to coordinate and lead cross-functional project teams, delivering results on schedule.
- Strong problem-solving skills to navigate ambiguity and provide structured solutions.
- Familiarity with operational excellence techniques, emphasizing root cause analysis.
- Proficiency in tools such as MS Word, MS Excel, MS PowerPoint, MS Visio, MS Project, and Trackwise.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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