Director of Quality

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About Chemify

Chemify is creating a future where the access to important molecules, drugs and new materials currently unimaginable are instantly accessible radically increasing the speed of innovation, quality of life, and reach of humanity. The company is building the infrastructure to digitize chemistry to design, make, and discover new molecules with the desired function and properties instantly and on-demand. Chemify has built a platform that combines purpose-built programming languages, robotics, AI, and the world's largest and continuously growing database of chemical programs to accelerate chemical discovery to new, transformative heights.

Chemify will transform Global Drug Discovery, scaling by orders of magnitude the rate at which new drugs can be discovered and be the first company to set this new paradigm.

Chemify is supported by some of the best investors from Silicon Valley and across the world, including Triatomic Capital, BlueYard ventures, DCVC, Founders Fund, and others.

Job Purpose

The Director of Quality will develop and implement Chemify's Quality Management System as an essential performance engine for the company, enabling the evolving needs of business growth, increasing customer expectations, global expansion of facilities and enhancements in deployable technology.

Working with across the business, alongside Chemists, hardware and software engineers, operations and supply chain specialists, management, technicians, and other stakeholders, the Quality Director will be expected to develop, plan, deploy, maintain and continuously improve the QMS ensuring its in-place and in-use implementation across all business processes within the scope of customer and commercial delivery, including but not limited to; Regulatory Compliance, Data Management, Personnel and Environmental Safety, Customer Focus and Vendor Assurance. Applying the QMS in a risk based manner appropriate to all areas of Chemify's world-class laboratories, facilities, infrastructure, R&D, and operational processes dedicated to Chemical discovery and manufacturing as appropriate to the current phase of company development.

The successful candidate will have experience building and managing Quality Systems (specifically ISO9001:2015 experience, with GLP and GMP experience useful but not essential), Quality teams (QA and QC), handling partner, regulatory and supplier audits. The candidate must relish operating in a fast-paced business where many processes are only being established and demands on them are growing significantly. The opportunity for impact, personal and professional growth and reward are very high - as is the requirement for a very high level of efficiency and exceptional cross-functional influence in the approach taken. The Director of Quality must be extremely motivated to make significant contributions to the development of a hyper-growth, silicon-valley style start-up by engaging deeply with other team members, and bringing both an owner's mindset and a growth mindset to critical business and quality processes and to the company in general. The Director of Quality will take on broad tasks on behalf of the team and company as they become necessary for the continuity of operations at Chemify.

As an early stage start-up employee, the Director of Quality will have the opportunity to work very closely with many stakeholders, including experienced laboratory and operations managers, to quickly establish best practices in laboratory management, supply chain, instrumentation management, and facilities management; while experiencing the rapid pace of personal and professional growth offered at a technology platform company.

The ideal candidate will be a smart, enthusiastic, energetic, and ambitious individual excited to wear many hats and contribute to the overall success of the company in a variety of capacity as the needs evolve.

Above all the candidate recognises Quality and the QMS as an engine for business performance and success and is highly motivated to ensure that the QMS is developed, implemented and deployed to optimise this business potential.

Key Responsibilities

• Work very closely with the leadership team, commercial and partnering team, and other stakeholders to establish Quality and Compliance objectives, and deliver against them.
• Assess compliance needs for partnering efforts and ensure Chemify's systems, processes, procedures, and activities exceed partner expectations
• Lead efforts to ensure data integrity is at the forefront of all company activities
• Establish and enforce, with the support of company leadership and the managers of the relevant teams, phase appropriate quality standards for the R&D, technology product development and commercial laboratory operations and functions
• Understand guidance from, and ensure compliance with all local, regional, and national regulatory bodies or agencies with purview over Chemify
• Supervise further development and implementation of the Quality Management System
• Supervise training and maintain training records
• Chair management review meetings, taking into considerations risks and opportunities for the business
• Provide regulatory training
• Monitor site performance and compliance and work closely with the laboratory operations team to develop and execute action plans to rapidly and continuously improve efficiency and quality of the chemical manufacturing laboratory
• Report regularly to management on topics affecting quality in the laboratory and company wide
• Participate in the continuous improvement efforts: 5S, gemba walks, performance management, problem solving etc...
• Perform regular internal audits
• Establish and maintain CAPA process for the entire organization

Requirements

MUST HAVE

• Must have Undergraduate degree in Chemistry, Biology, other laboratory sciences, or equivalent topic / work experience
• At least 10 years of experience in the Quality field, in a scientific and operational environment
• At least 3 years of experience supervising a Quality team in a scientific and operational environment
• Deep and successful experience with establishing compliance and leading the external audit process from partners, regulatory authorities, accreditation bodies, and others
• Strong track record in successfully influencing cross-functionally a variety of stakeholders towards compliance with mission critical processes and expected behaviors, using a variety of tools and techniques
• Functional knowledge of Quality Management Systems (ISO9001,GLP,GMP, Other standard) experience with implementation from "ground zero" and/or significant remediation experience to an already established but "failing" QMS
• Excellent leadership skills, including mentoring and training other members of staff at all levels
• Experience in a highly collaborative, fast-paced, work environment, industry or otherwise
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Strong work ethic and positive predisposition to learn quickly and apply learnings
• Excitement at the opportunity to participate in the growth of a world-changing company
• Excellent interpersonal skills, including assertiveness, persistence and flexibility
• Exceptional written and oral communications skills, including a demonstrated ability to interact with partners
  NICE TO HAVE
• Experience in early-stage start-ups and building team from scratch
• Experience with EHS regulation and EHS Management System Implementation
• Experience of ISO9001:2015 regulatory compliance is preferred
• Experience in alternative ISO standards is preferred
• Experience in GMP setting is preferred