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Director of Quality
4 months ago
Do You Want to Improve the Future of Healthcare?
- Want to enable the world's top scientist to deliver impactful healthcare solutions faster?
- Do you believe that the best team wins?
- Do you thrive on providing innovative solutions to unique challenges?
- Do you enjoy a fast-paced environment requiring flexibility and adaptability?
If so, we would like to meet you.
Who We Are
Biosero, Inc. is the leader in life science robotic automation and integration. Our award-winning no-code software tools enable vital research to be done quickly while freeing scientists to address additional scientific challenges. Our solutions are placed in the top accounts worldwide, including the top: pharmaceutical, agricultural, clinical, diagnostics, and biotech companies. Our work impacts the world by accelerating productivity, discovery & cures. Our team is passionate about our mission to enable discoveries in life science by coupling our software platforms with data and robotics. Biosero is the fastest-growing software company in the life sciences space. We have been voted the best place to work for many years.
ONSITE ROLE
The Director of Quality manages the development, implementation, and maintenance of Biosero's Quality Management System (QMS) and processes. This position will interface with associates across the organization including engineers, scientists, technicians, software developers, and our business and leadership teams, ensuring compliance with company Quality standards, customer requirements, and global regulations.
Responsibilities
- Administer and serve as leader of the Biosero Quality Management System (QMS)
- Establish overall short- and long-term Quality strategy and objectives.
- Conceive, document, and train QPs, SOPs, and work instructions across company disciplines.
- Monitor Quality objectives & performance; provide regular reports to Executive leadership.
- Ensure that Biosero's work product adheres to relevant industry standards and customer requirements (ISO9001, CE, 21CFR Part 11, ISO27001).
- Stay informed about regulatory changes and ensure continued compliance with relevant guidelines.
- Serve as company lead for third party regulatory audits and customer audits, queries, and inspections.
- Serve as the company focal point for Sustainability initiatives, audits, queries, and guidance, and also act as the liaison to BICO Sustainability efforts.
- Define standards and support the team in maintaining appropriate Quality documentation, including Quality Procedures, test protocols, reports, and compliance records.
- Conduct risk assessments to identify potential quality issues and work with the team to develop mitigation strategies.
- Lead risk assessments tied to regulatory certifications (e.g. CE mark).
- Establish standards and processes for Supplier Quality management and oversight.
- Define inspection processes and tracking methods.
- Perform audits of critical suppliers.
- Lead Biosero Supplier Quality Team, methodically driving improvement.
- Serve as the voice of Quality at Biosero, responding to client inquiries and leading client audits.
- Develop and lead customer complaint handling program.
- Train employees on Quality processes and foster a culture of Quality consciousness and compliance.
- Drive continuous improvement initiatives to enhance overall Quality System effectiveness and efficiency.
- Performs all other duties as assigned.
Qualifications
- 10+ years of relevant work experience in Quality and Operational Excellence in a complex technical organization
- Experience defining and building a QMS from its early stages
- Knowledgeable in international quality standards (ISO9001, CE, 21CFR Part 11, ISO27001), certifications, and audits
- Bachelor's degree or higher in a field related to Quality Systems such as Quality Management, Engineering, Business Administration, or other related field
- Relevant certifications for ISO or ASQ are desirable
Required Skills
- Experience with ISO 9001, 21CFR Part 11, ISO27001, and CE certification requirements; familiarity with QSR, ISO 13485 a plus
- Prefer experience in Quality methods and tools like value stream analysis, 5 Why's analysis, Kaizen, FMEA, 8D, Ishikawa diagrams, etc.
- Experience with ERP systems a plus
- Hands-on team player with a continuous-improvement mindset and sense of ownership and urgency
- Outstanding attention to detail and strong organizational skills
- Able to thrive in a rapidly growing start-up-company environment
- Proven leader; able to work with limited supervision
- Excellent communication and collaboration abilities
- Experienced in the application of QMS management tools (e.g. Qualio); proficient in Microsoft Office applications
- May require domestic and international travel (5-10%)
Compensation and Benefits
Salary range is $130, ,000 per year, depending on experience. Benefits include 401K with company match, Flexible Vacation Policy, Health Benefits, Investment in Professional and Personal Development, and much more.
