Director of Quality (Life Sciences)

Are you a seasoned manufacturing and product quality expert in the medical device and / or life sciences with a passion to take on a newly created role within a leading next generation sequencing solutions provider?

Do you thrive in an environment with diversity, communication, collaboration, and teamwork as the core values?

As the Director of Quality , you will be responsible for leading our quality department and defining the global quality, regulatory and clinical strategies.

You will be responsible for the QMS development, implementation, and maintenance to comply with applicable Quality System Regulations, In Vitro Diagnostic Regulations (IVDR) and ISO standards.

WHAT YOU WILL BE DOING

• Leads the quality department.
• Manages processes and teams associated with control of nonconforming products, CAPAs, deviations, complaints, supplier management, post-market surveillance, audits, document control, acceptance activities, risk management and other Quality related activities.
• Partner and advise development and business teams around quality, regulatory, and clinical requirements for the development and commercialization of new product platforms, solutions and services.
• In partnership with the VP of Operations, establishes overall short and long-term quality strategy and objectives. Ensure operational quality assurance goals are aligned with department and company objectives.
• Works with suppliers, contract manufacturers, and internal manufacturing organizations to meet quality target goals, and drive issue resolution for quality problems.
• Interfaces with other departments and partners to ensure implementation of good compliance practices.
• Initiates and manages projects to continuously improve and increase efficiency of quality processes.
• Serves as the key interface with regulatory agencies, including FDA, notified bodies, and international regulatory authorities.

Prepares for and leads third party regulatory and supplier audits and inspections.

• Ensures compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies.
• Establishes and manages training programs focused on cGMP, QMS, defect awareness, Quality at the Source, and other training programs that promote quality awareness and understanding.
• Monitors development of new or updates to existing regulations and accurately and effectively translates them into workable processes and procedures.
• Promotes the Culture of Quality throughout the organization.
• Works across sites to harmonize and / or align processes.
• Creates reports for and manages meetings covering Management Reviews.
• Manages projects and / or cross functional teams as needed.
• Creates bench-marking opportunities to seek best practices with the intention to improve internal processes.
• Motivates and manages teams for high engagement and performance.

ABOUT YOU

• Proven people manager and able to work with minimum supervision.
• Excellent verbal and written communication skills.
• Excellent attention to detail and ability to multi-task.
• Must be able to develop, lead, and motivate a team within a fast-paced manufacturing and design setting.

WHERE YOU WILL WORK

Full-time, on-site, San Jose, CA at Complete Genomics.

WHAT YOU WILL BRING US

A minimum of 15 years of related experience with a Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 8 years’ experience;

or equivalent experience in Quality Assurance / Regulatory Compliance management for the design, production, and on-market support of medical or IVD products.

• At least 5 years of people management experience.
• Proven track record in leading multiple teams effectively
• Proven success with project management and implementation of quality system improvements.
• Strong understanding of applicable regulations, such as but not limited to IVD Regulation, QSR, ISO 13485, ISO 14971, etc.
• Knowledge of Operational Excellence, extremely intuitive with problem solving and resolutions utilizing risk management tools.
• Strong leadership skills, including coaching, team-building, training and conflict resolution.
• Extensive business acumen, technical knowledge, and industry experience encompassing one or more engineering, technology, and product domains.
• Organizational and strategic management skills, including budget and business planning.

WHAT YOUR EDUCATION LOOKS LIKE

• Bachelor's degree required in life sciences, biological, engineering, or equivalent technical field.
• ASQ Certification or equivalent experience preferred.

HOW WE WILL REWARD YOU

The base salary range for this position is $175,000 $210,000*.

• This position is eligible to earn an a nnual bonus plan to say thank you for all your hard work.
• Annual gym membership reimbursement to keep you healthy.
• Employee discount program to save you some money.

We offer eligible employees and their dependents (including domestic partners) a comprehensive and competitive benefits package.

Complete Genomics contributes to the benefits package.

• Medical, Dental and Vision Coverage
• Life and AD&D Insurance
• Long-term and Short-term Disability Insurance
• Voluntary Life and AD&D Insurance
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• Domestic Partner Benefits
• Commuter Program
• Employee Assistance Program
• 401(k) Retirement Plan
• Education Assistance
• 20 PTO days and 11 holidays per year

Complete Genomics provides equal employment opportunity without regard to race, color, religion, sex, national origin, sexual orientation, gender identity and / or expression, age, disability, veteran or uniformed service status, or any other characteristic protected by applicable law.

The final salary offered is commensurate on experience, education, position location, market factors, internal equity, and others.