Rapid Micro Biosystems Director, Quality in Lowell, Massachusetts
The Director of Quality will develop and manage the quality systems required at Rapid Micro Biosystems (RMB) in order to support the demanding expectations of our Pharmaceutical customers. Ensure that the finished product is fit for its purpose and meets both external and internal requirements, including legal compliance and customer expectations. Oversee the activities required to meet quality standards. The incumbent must be a self-starter who is comfortable working in a dynamic, team-based environment to reach common objectives with aggressive schedules.
Reports to the VP of Quality.
Manage and maintain the company?s Quality Management System while maintaining ISO9001 certification, CE markings, RoHS compliance, and expected customer GMP compliance.
Maintain a strong customer-centric environment while managing and leading cross-functional actions to support customer requirements and improvements.
Ensure product requirements are well documented and meeting customer and industry requirements at all times.
Maintain a strong proactive quality focus by anticipating problems, driving, and providing input on solutions, leading, and facilitating change to ensure effective improvements.
Work cross-functionally to establish a strong culture around corrective actions and continuous quality improvements. Lead and facilitate the implementation of appropriate methods and tools, including advanced problem solving and statistical methods.
Lead, manage, and support product and process validations to ensure all requirements are met and the highest standards of quality are maintained.
Manage supplier selection, quality planning, metrics, and improvement activities to achieve the highest levels of 1st pass yields.
Develop, lead, and maintain a comprehensive suite of metrics supporting the Quality System and products and maintain a rigorous schedule of reviews and planned improvements.
Establish and maintain metrics and reports to support Monthly Business Reviews and the annual Quality System Management Review.
Perform root cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
Coordinate and manage internal and external audits with certifying bodies and customers and resulting corrective actions and continuous improvement opportunities.
Ensure in-process inspections, metrics and statistics are in place to ensure product quality requirements are being met at all stages of the process.
Ensure final product documentation and records are accurately completed, approved, and maintained; including nonconformances and deviations
Performs supervisory tasks which include personnel assessment, hiring, training, and managing the quality department workforce including disciplinary functions.
Prepare and deliver annual performance evaluations for direct reports.
Generates and supports development plans for all direct reports to allow them to take on additional responsibilities.
Supports and drives process improvements and team culture
Bachelor?s degree in Engineering, Microbiology or related field, or equivalent experience. Master?s degree preferred.
10+ years? experience in a quality assurance role in a manufacturing organization.
5+ years? experience managing quality teams, helping to shape quality strategy.
GMP experience required; Medical Device, Life Science tools or robotics experience highly preferred.
Must have proven experience with problem-solving methodologies, including Six Sigma, Lean, and Statistical Process Control. Black or green belt certification preferred.
Previous experience establishing quality-related policies and procedures.
Ability to communicate and express ideas clearly, across all levels of the organization. Effective verbal and written communication, analytical, and interpersonal skills.
Must be able to understand the role in the overall business process and appropriately support all organizations.
High volume consumables and strong process control knowledge highly preferred.
Expertise in Microsoft Office applications including Project, Word, Excel and PowerPoint, Agile, and MRP/ERP systems.
Ability to negotiate and influence with or without authority and manage expectations.
Ability to successfully work on multiple projects at once.
Essential skills to communicate and contribute outside of defined job description.
Ability to work in a fast-paced, changing environment with minimal supervision. Work independently, establish priorities, and make decisions.
Work is mainly in a general office setting.
Sitting and using computers along with being in manufacturing areas.
Drive/fly to vendor locations as needed
Ability to move or lift equipment/product up to 30 lbs. on occasion.
May be required to work extended hours and weekends
SPECIAL NOTICE: How do we protect our employees from COVID-19?
Our Lowell facility is fully CDC compliant and as well we follow the State of Massachusetts and local guidelines. At Rapid Micro Biosystems employee health & safety is our top priority. We have implemented and maintain precautions to prevent the spread of COVID-19 at our facility. We provide masks, appropriate PPE gear, and hand sanitizer to all essential employees who must report to work. Before entering the facility, employees have their temperatures checked. In addition, we take great care that all frequently touched surface areas are sanitized throughout the day, as well our facility is fully cleaned daily.
Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.
The company?s Growth Directthe first and only growth-based system to automate rapid compendial QC Micro testing?ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.
Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
Rapid Micro Biosystems is headquartered in Lowell, Massachusetts, with operations in Lowell and Freising, Germany.
Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.
Please no phone calls or agencies please.