Manager, Quality Management System
4 weeks ago
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job Overview
The Manager of QMS will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations. The Manager of QMS will first contribute to quality plans, training, document and record control system implementation, and Quality Management System items such as the Quality Manual, Quality Cross System reference, and Management Review. This role will also contribute to all areas of QA and Regulatory activities as Sequel builds out systems, and external manufacturing development.
Job Responsibilities and Essential Duties
- Responsible for lifecycle management of policies and procedures in the GxP Quality Management System (QMS) Framework, including providing support with document authoring, approval, issuance, training, implementation, periodic review, and retirement.
- Responsible for document management for GxP records generated internally and externally.
- Contribute and support ongoing improvement efforts within quality systems and maintain quality systems to ensure compliance with applicable local and global regulations while meeting Sequel’s business requirements.
- Provide support during health authority inspections, internal audits, and other external audits.
- Develop, implement, and maintain a comprehensive quality management system (QMS) in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820)
- Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820).
- Develop and maintain documentation templates within the QMS and project databases and maintain hard copy records when required.
- Maintain site compliance with good documentation practices and cGxP data integrity requirements.
- Partners with functional areas to conduct periodic reviews of existing procedures and development of new and revised procedures.
- Serve as system administrator for account creation, password reset, signing authority management, approval routing workflows, user permissions, and general troubleshooting for Sequel’s quality management and documentation systems.
- Provide end-user onboarding and ongoing training for all program and project management systems for all staff and stakeholders.
- Establish key performance indicators (KPIs) and departmental metrics to monitor and improve quality across all functions.
- Responsible for tracking batch records, logbooks, and other controlled forms/documents.
- Drive and facilitate change management.
- Manage and train a team of quality professionals.
- Collaborate with other departments to ensure quality is integrated throughout the product lifecycle, addressing quality-related issues and implementing solutions.
- Foster a collaborative and inclusive team culture of quality professionals that values diversity and promotes innovation, and develops succession plans, skills assessments, and training.
- Bachelor’s degree in technical field, or equivalent experience.
- 5+ years of experience working in a quality function within a medical device company (preferred), pharmaceutical or biotech company.
- Experience leading a team (preferred).
- Strong knowledge of Quality Management or Quality Engineering Principles and methodologies.
- Excellent problem-solving and analytical skills.
- Strong project and team leadership skills.
- Excellent communication skills (both verbal and non-verbal). Must be able to quickly and concisely summarize complicated technical topics.
- Quality certifications a plus: ASQ, CQE, CQM.
- Ability to exercise professional judgment in identifying organizational improvement.
- Ability to effectively work with cross-functional teams as a change agent, facilitator, coach, and mentor.
- Ability to travel nationwide and internationally, up to 10%.
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
- Physical requirements such as lifting specific weights
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Manager, Quality Management System
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Manchester, United States Sequel Medical Technology Full timeAbout SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.Job OverviewThe Manager of QMS will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations. The Manager of QMS will first contribute to quality plans, training, document and...
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