Director of Quality Assurance

General Responsibilities:

• Oversee quality aspects of Intuitives 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 Intuitives Regulatory and Quality organization to develop and oversee quality activities and ensure that Intuitives 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 Intuitives Quality organization to ensure quality events are thoroughly investigated and product meets Intuitives 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 Intuitives 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 Intuitives 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 . 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.

Remote Work :

No

Employment Type :

Full-time