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:
The Associate Director Quality Management Systems, reporting to the Sr. Director Manufacturing Quality Operations and Quality Systems, ensures site level quality systems are appropriately designed, implemented, and measured for cGMP compliance and effectiveness. This role also develops and leads the Quality Management Systems team to implement plans to mitigate product and/ or process risks and to educate the facility on risk identification, root cause analysis, and investigative measures. Areas of responsibility include Change Control, Non-conformance and CAPA management, Document Control, Training, Supplier Quality, and Inspection Readiness. This role will be tasked with understanding the underlying quality issues and developing successful solutions, changing practices where necessary to ensure that standards are maintained.RESPONSIBILITIES:
QMS responsibilities include but are not limited to: Quality Manual, Quality Management Review, Quality Planning, Training, Supplier Quality, Internal/External Audit, Change Control, Document Control, and Inspection Readiness.
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Leads or participates in audit and inspection preparation, resolution of findings and liaises with auditing groups and inspectors through all stages of the audits (Internal, Customer/Partner, Regulatory).
- Ensures the quality assurance programs and policies are maintained and improved regularly.
- Drives continuous improvement for effective quality systems and to address recurring issues identified that impact the overall health of the quality system.
- Represents the Quality Unit at various project meetings and provide quality input in the resolution of quality-related issues.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Leads a group or team of employees in the achievement of organizational goals. Guides, coaches, directs, and develops direct reports, and drives those practices throughout the organization.
- Supports and maintains an environment that fosters communication and teamwork.
- Participates in product development and design control activities as required.
- Applies current Good Manufacturing Practice (CGMP) requirements, guidelines and practices.
- Reviews, understands, and aligns with Invitae HIPAA Security policies and procedures.
- Processes and handles European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
- Bachelor's degree in Engineering, Scientific or Technical discipline.
- Minimum 7 years relevant (medical device, pharmaceutical) experience with 5+ years of managerial experience.
- Prior experience with ISO 13485, EU MDR and U.S. 21 CFR 820 regulations for medical devices.
- Certified Quality Manager, Engineer, or Auditor or previous auditing experience preferred.
- Strong project/time management skills with the ability to organize and handle multiple priorities.
- Excellent communication skills with the ability to positively influence key stakeholders without direct authority.
- Quality Management System Software implementation experience preferred.
- High attention to detail and accuracy.
In Colorado, our competitive compensation package includes a base salary starting from $137,920. In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.
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
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.