Associate Director, Manufacturing Quality Operations
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.Position summary:
As the Associate Director, you will develop the overall quality and continuous improvement strategy for the Manufacturing Quality department. Your leadership will establish an environment of quality excellence. You will implement a statistical based quality system, develop manufacturing quality systems in compliance with US FDA Regulations and ISO 13485:2016 standards, and maintain supplier quality relationships.
This role reports to the VP of Quality Control and Manufacturing Engineering and is located onsite in Boulder, CO.Responsibilities:
Job performance will involve a variety of activities including:
- Build strong quality systems for aligning appropriate infrastructure and resources required for department to achieve business objectives.
- Partner with the Directors of Manufacturing and Supply Chain to create and direct programs to ensure the quality of the product.
- Ensure internal processes and metrics are aligned to create the highest product quality and competitive advantage.
- Provide guidance to ensure collaboration with marketing, business development, and product development.
- Implement and maintain the vital programs to support the related Corporate Quality Policy, Quality System, and CI initiatives.
- Oversee investigations of quality issues to insure timely closed loop corrective actions and reports as required.
- Support supplier quality programs; conduct supplier audits as needed to meet objectives.
- Provide training and leadership and represent a positive and hardworking role model to ensure high engagement across the team.
- Review, understanding, and compliance with company HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by the company for purposes of personalized molecular pathology.
- 12+ years of experience in Quality Assurance / Quality Control with 5+ years in a leadership position.
- Bachelor's degree required; Master's preferred.
- IVD / Medical Device / Pharmaceutical industry experience.
- Knowledge of cGMP/CFR/FDA regulations; International regulatory experience a plus.
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company
- Strong communication and presentation skills
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
**Compensation for the role will depend on a number of factors, including a candidate’s geographic location, qualifications, skills, competencies and experience and may fall outside of the range shown. Expected Pay Rate in Colorado from: $152,000.00
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.