Director of Quality Assurance (Finance)

Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
General Responsibilities:

• Oversee quality aspects of Intuitive's Fluorescence Imaging program -plan, organize and prioritize work activities based on goals and priorities for QA.
• The candidate will interact with and provide oversight to external Quality consultants as necessary to accomplish programmatic goals. As such, broad knowledge of QA as it pertains to GLP, GCP and GMP is desired.
• Knowledge of ICH and Good Data Practices highly recommended.
• Work closely with the Fluorescence Imaging team (including Document Controls and CMC) and Intuitive's Regulatory and Quality organization to develop and oversee quality activities and ensure that Intuitive's QA standards are met and conform to GCP and GMP regulations.
• Develop, improve, and maintain Quality Management System (QMS) relevant to work performed by Intuitive Fluorescence Imaging, including review and approval of QMS documentation, SOPs, batch record review, and batch disposition.
• Keep up to date with all related quality legislation and compliance issues.
• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
• Administer the document management system for the department.
• Prepare and assist in annual reports and quality trending reports.
• Monitor, document, and report on the status of the quality levels of, systems and production activities.
• Document internal compliance processes, and prepare materials for submission to regulatory agencies.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Evaluate quality events, incidents, queries, and complaints.
• Work closely with Intuitive's Quality organization to ensure quality events are thoroughly investigated and product meets Intuitive's quality standards.
• Assist with regulatory inspections and external audits as needed. This includes preparing the staff to establish and maintain adequate processes for hosting regulatory interactions.
• Participate in various cross-functional projects within continuous improvement and new programs.

GMP-related Responsibilities:

• Day-to-day quality assurance activities related to GMP compliance of Intuitive's CMOs producing drug substance, drug product and finished goods.
• Manage cross-functional investigations to resolve potential product quality issues.
• Effectively interact with external contract manufacturing organizations and other service providers, and work as part of an internal multidisciplinary team to help manufacturing and testing needs of clinical trials and commercial product.
• Assist CMO for preparation of Preapproval Audit Inspection activities
• GMP Manufacturing Quality oversight of process and method validations, change controls, investigations, and Supplier Qualification.
• Accountable for ensuring product is dispositioned to meet Intuitive's timelines for distribution.
• Responsible for intermediate, drug substance, drug product and finished good batches including approval of completed manufacturing batch records, non-conformances and ensuring adequate root cause analysis and investigation activities are performed by CMOs.
• Accountable to coordinate with International Quality team members to help with further regional product release and regulatory filing/distribution requirements.
• Responsible for providing inputs for the continuous monitoring of GMP compliance of the supply chain, including evaluation of supplier quality incidents and escalation to Senior Management as risks arise.
• Work with cross-functional groups and CMOs to manage receipt, review, approval, and storage of documents provided by CMOs.
• Help continued risk-based supplier qualification program and creation or review of related Quality Technical Agreements (QTA).

GCP-related Responsibilities

• Contributes to the development, implementation, and maintenance of GCP quality systems and SOPs.
• Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
• Contribute to the development, implementation, and maintenance of GCP quality systems and SOPs.
• In partnership with Clinical Operations and other impacted functional areas contribute to the design and implementation of a risk-based clinical Quality Assurance management system.
• Develop and execute strategic plans to identify, mitigate, monitor, and report site, study and program level compliance risks.
• Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study.
• Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management.
• Manage the clinical investigator site audit program. Set up a risk-based approach to clinical site audits and work with the clinical team to detail risk-based criteria. Ensure the site audits are appropriately scoped, planned, executed and resolved.
• Develop and implement risk-based GCP audits and compliance strategies. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
• Coordinate with functional area leads and vendors on Inspection Preparation activities including mock inspections, gap assessment, story boarding, and resolution and mitigation of identified compliance concerns.
• Other duties as required.

Qualifications

• Minimum B.Sc. Degree in Life Sciences or Engineering field
• 12 years of experience in the pharmaceutical or medical device industry, with at least 8 of the years in the pharmaceutical industry,
• Small molecule experience preferred.
• Sterile preparation experience required.
• 7 years of direct Quality Assurance management experience in regulated industry (pharma/biotech and medical device)
• Broad knowledge of GxP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations

Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Base Salary Range Region 1: $204.600 USD - $307.000 USD
Base Salary Range Region 2: $173.900 USD - $260.900 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.