Senior Director, Quality Assurance

The Corporate Quality Team is responsible for the overall Quality across Ginkgo. We focus on the defining and measuring Quality, QMS (Quality Management System) implementation, training, maintenance and continuous improvement.  The QMS is the foundation to Ginkgo’s quality culture as it includes quality issues escalation process, internal and external audits, and risk assessment programs. ) Generally we ensure Ginkgo is executing high quality science and is in compliance with all required regulations for s. We deliver on this by providing centralized quality leadership and resources and b partnering with all functions across the organization.  A high standard of quality is critical to the services and products Ginkgo provides as we are revolutionizing how biology can be engineered.

Job Description:

• Design, develop, and implement a Quality Management System through which quality at Ginkgo will be managed.
• Implement a system which will assure that the organization complies with the QMS and all required quality standards and regulations. Maintains the company's quality system and issues updates.
• Drive, promote, and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiencies
• Responsible for annual audit plans including supplier/vendor qualification audit and inspection management
• Ensure that the Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activity
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management
• Provide regulatory and quality support for cross-functional activities as needed • Provide strategic and technical leadership of quality assurance activities, including cross-functional effort to develop policies, processes, and SOPs on both N-GXP and GXP and ensure compliance with global and regional regulations and ICH guidelines
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management
• Ensure quality metrics comply with best industry standards and practices
• Demonstrate Quality leadership to the site providing guidance and interpretation on the regulatory requirements..
• Lead the assigned Quality Assurance organization to generate a strong quality culture of engaged and motivated staff maintaining strong working relationships with external customers and internal customers: -Quality Operations QC, manufacturing, engineering, supply chain and R&D. Implement and maintain a compliant QMS that is simple to understand and follow.
• This role will partner with our EHS function, but will not be directly responsible for EHS functions.
• This is a  new role for Ginkgo as we expand our Quality function and will include the creation of many of the processes to effectively implement all of the above.
• This role may develop into the direct management of 2-4 QA professionals that will align with various functions across the organization.

This position will be hybrid based out of our Drydock (Boston, MA) Location

Responsibilities:

• Provide proactive strategic regulatory and compliance guidance in support of Ginkgo’s current and potential future funnel of work and work locations (including various states and countries.
• Provide regulatory  guidance at the project level to ensure we are prepared to execute individual projects in compliance with all applicable regulatory guidance.
• Partner with our EHS function to ensure compliance with all applicable regulatory , environmental and safety requirements that effectively provide Ginkgo with a “license to operate”.
• Coordinate, facilitate and lead all (non-EHS) compliance external audits performed by customers and regulatory bodies.
• Partnering across operations teams, Develop and implement internal process audit plans across key functions.
• Track and report on all internal and external audits findings.
• Provide regular communication and educational opportunities across Ginkgo to objectively improve our awareness and knowledge of applicable regulatory requirements.
• Support the development of Quality related SOPs across operational teams.

Minimum Requirements:

• Masters degree (or equivalent experience with a Bachelor's) in Science or Quality related discipline plus 11-13+ years of related experience
• Experience building and leading teams

Preferred Capabilities and Experience:

• Familiarity with  applicable regulatory bodies overseeing the BioTechnology and Genetic Engineering space.
• Knowledge of Quality development and execution within scientific Discovery  laboratories.
• Proven ability to successfully manage both audit preparedness and inspections activities in Lab based functions.
• Ability to collaborate with senior management to drive Quality compliance, execution and improvement.
• Proven ability to measure complex quality goals that positively impact both our compliance and our achievement of business goals.