Rapid Micro Biosystems
Sr. Director, Quality
Rapid Micro Biosystems, Lowell, Massachusetts, United States, 01856
Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit.
Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business.
The Senior Director of Quality/Head of Quality will oversee all aspects of the company's quality functions, ensuring the highest levels of compliance, product quality, and customer satisfaction. This role is crucial in aligning quality strategies with company objectives, driving a cGMP culture transformation, and positioning quality as a competitive advantage to support our capital equipment systems, consumables, and services product portfolio. The Senior Director will work closely with the executive team to develop comprehensive quality strategies and targets, while also acting as a primary communications conduit for key customers on significant quality issues.
This individual will lead initiatives to ensure regulatory compliance, enhance customer experience, and support the company's commercial success through quality excellence. Additionally, the Senior Director will drive cultural and operational change, implement lean quality practices across the enterprise and directly contribute to accelerating improvements across the entire organization.
ESSENTIAL JOB FUNCTIONS
Strategic Quality Leadership:
•Collaborate with the Executive Leadership Team (ELT) to shape and implement both long- and short-term quality strategies aligned with corporate objectives.
•Integrate customer expectations and policies into our quality strategy: Develop and execute a comprehensive, globally aligned quality strategy that enhances the customer experience, optimizes business performance, and ensures adherence to ISO 9001:2008, IEC standards, and other international quality frameworks. This strategy will support the regulatory requirements, and compliance needs of our pharmaceutical clients who adhere to global cGMP regulations, including FDA, EMA, WHO, and other international regulatory bodies, ensuring alignment with diverse market needs and worldwide best practices
•Serve as a primary liaison for key customers on critical quality issues, ensuring timely, transparent, and effective communication.
•Lead efforts to unlock product quality as a driver of customer satisfaction and sales by consistently improving product reliability and performance in collaboration with other functions in the company.
•Develop and implement key metrics to identify areas of improvement and track business results
Quality Management:
•Oversee and ensure the optimal performance of the QC Microbiology, Quality Systems, Quality Engineering, Receiving Inspections, Calibration, Supplier Quality, and NPD Quality
•Formulate and advocate for quality policies that enhance the company's competitive edge and profitability, ensuring that product quality supports business growth and customer retention.
•Lead significant quality improvement projects, including new product development (NPD) quality initiatives and capital investments to maintain the highest standards.
Customer-Focused Quality Initiatives:
•Collaborate closely with Customer Experience, Sales, R&D, Operations, and Supply Chain to ensure alignment of quality initiatives with customer and business requirements.
•Leverage customer feedback to implement product improvements, working closely with the Customer Experience function and Product Management and creating a competitive differentiation in the marketplace.
•Proactively lead the company's preparation for regulatory and customer audits and act as the main point of contact for auditors and significant customers during these processes.
•Identify, assess, and mitigate potential quality risks through rigorous quality systems and preventive measures.
Organizational Transformation & Cultural Change:
•Act as the driving force behind the adoption of cGMP behaviors and a culture of quality throughout the organization, from senior leadership to the production floor.
•Lead company-wide training and development programs to foster quality awareness, ownership, and accountability at all levels.
•Accelerate organizational change to ensure the seamless integration of quality principles into new product development, manufacturing processes, and daily operations.
Supplier Quality & Partnerships:
•Establish and maintain strong supplier quality management systems to ensure the quality of incoming materials, components, and services.
•Collaborate with suppliers to resolve issues, improve quality performance, and foster a culture of continuous improvement throughout the supply chain.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
•Bachelor's degree in Engineering, Life Sciences, or a related field; MBA or advanced degree preferred.
•Extensive experience (10-15 years) in quality leadership roles within the life sciences, pharmaceuticals, or medical device industries.
•Demonstrated success in driving lean quality implementations
•Hands-on leadership experience in a regulated manufacturing environment, with a deep understanding of cGMP, FDA, EMA, MHRA, ISO, and other industry standards.
•Proven ability to lead organizational change and foster a quality-centric culture, with a track record of successful transformations.
•Experience in customer communications on quality issues, with a focus on building trust and ensuring customer satisfaction.
•Strong fiscal acumen and experience in quality-driven commercial outcomes.
SUPERVISORY RESPONSIBILITY
•Lead and develop the quality management team, providing strategic direction and operational oversight.
•Assist the executive team in defining organizational goals and quality-focused strategic plans, providing leadership with a deep understanding of quality operations and business needs.
ABOUT RAPID MICRO BIOSYSTEMS:
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 Direct™-the 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 Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore.
Equal Opportunity:
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.
Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business.
The Senior Director of Quality/Head of Quality will oversee all aspects of the company's quality functions, ensuring the highest levels of compliance, product quality, and customer satisfaction. This role is crucial in aligning quality strategies with company objectives, driving a cGMP culture transformation, and positioning quality as a competitive advantage to support our capital equipment systems, consumables, and services product portfolio. The Senior Director will work closely with the executive team to develop comprehensive quality strategies and targets, while also acting as a primary communications conduit for key customers on significant quality issues.
This individual will lead initiatives to ensure regulatory compliance, enhance customer experience, and support the company's commercial success through quality excellence. Additionally, the Senior Director will drive cultural and operational change, implement lean quality practices across the enterprise and directly contribute to accelerating improvements across the entire organization.
ESSENTIAL JOB FUNCTIONS
Strategic Quality Leadership:
•Collaborate with the Executive Leadership Team (ELT) to shape and implement both long- and short-term quality strategies aligned with corporate objectives.
•Integrate customer expectations and policies into our quality strategy: Develop and execute a comprehensive, globally aligned quality strategy that enhances the customer experience, optimizes business performance, and ensures adherence to ISO 9001:2008, IEC standards, and other international quality frameworks. This strategy will support the regulatory requirements, and compliance needs of our pharmaceutical clients who adhere to global cGMP regulations, including FDA, EMA, WHO, and other international regulatory bodies, ensuring alignment with diverse market needs and worldwide best practices
•Serve as a primary liaison for key customers on critical quality issues, ensuring timely, transparent, and effective communication.
•Lead efforts to unlock product quality as a driver of customer satisfaction and sales by consistently improving product reliability and performance in collaboration with other functions in the company.
•Develop and implement key metrics to identify areas of improvement and track business results
Quality Management:
•Oversee and ensure the optimal performance of the QC Microbiology, Quality Systems, Quality Engineering, Receiving Inspections, Calibration, Supplier Quality, and NPD Quality
•Formulate and advocate for quality policies that enhance the company's competitive edge and profitability, ensuring that product quality supports business growth and customer retention.
•Lead significant quality improvement projects, including new product development (NPD) quality initiatives and capital investments to maintain the highest standards.
Customer-Focused Quality Initiatives:
•Collaborate closely with Customer Experience, Sales, R&D, Operations, and Supply Chain to ensure alignment of quality initiatives with customer and business requirements.
•Leverage customer feedback to implement product improvements, working closely with the Customer Experience function and Product Management and creating a competitive differentiation in the marketplace.
•Proactively lead the company's preparation for regulatory and customer audits and act as the main point of contact for auditors and significant customers during these processes.
•Identify, assess, and mitigate potential quality risks through rigorous quality systems and preventive measures.
Organizational Transformation & Cultural Change:
•Act as the driving force behind the adoption of cGMP behaviors and a culture of quality throughout the organization, from senior leadership to the production floor.
•Lead company-wide training and development programs to foster quality awareness, ownership, and accountability at all levels.
•Accelerate organizational change to ensure the seamless integration of quality principles into new product development, manufacturing processes, and daily operations.
Supplier Quality & Partnerships:
•Establish and maintain strong supplier quality management systems to ensure the quality of incoming materials, components, and services.
•Collaborate with suppliers to resolve issues, improve quality performance, and foster a culture of continuous improvement throughout the supply chain.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
•Bachelor's degree in Engineering, Life Sciences, or a related field; MBA or advanced degree preferred.
•Extensive experience (10-15 years) in quality leadership roles within the life sciences, pharmaceuticals, or medical device industries.
•Demonstrated success in driving lean quality implementations
•Hands-on leadership experience in a regulated manufacturing environment, with a deep understanding of cGMP, FDA, EMA, MHRA, ISO, and other industry standards.
•Proven ability to lead organizational change and foster a quality-centric culture, with a track record of successful transformations.
•Experience in customer communications on quality issues, with a focus on building trust and ensuring customer satisfaction.
•Strong fiscal acumen and experience in quality-driven commercial outcomes.
SUPERVISORY RESPONSIBILITY
•Lead and develop the quality management team, providing strategic direction and operational oversight.
•Assist the executive team in defining organizational goals and quality-focused strategic plans, providing leadership with a deep understanding of quality operations and business needs.
ABOUT RAPID MICRO BIOSYSTEMS:
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 Direct™-the 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 Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore.
Equal Opportunity:
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.