Clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Company core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies.
- Reports directly to the VP, Global Regulatory Affairs & Compliance and is responsible for working collaboratively across multi-functions including clinical, manufacturing and quality regarding GxP (GLP, GCP, PV, GMP) compliance to provide strategic GxP compliance support to assure adherence to global health authority requirements.
- The Director is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the functions within the organization to streamline the integrated approach to quality and compliance throughout the product life cycle.
- The Director will also work collaboratively with the cross-functional leaders to assess/ monitor quality and compliance operational performance indicators across the network, to implement and advance compliance action plans and to seek opportunities to proactively identify areas for enhancement.
- Ensure company system (policies/ directives) and operation meet and/or exceed current requirements in GXP’s (GLP, GCP, PV, GMP) of applicable regulations, rules and guidance.
- Perform audits of clinical trials, vendors, internal processes and pharmacovigilance activities.
- Understand and apply GXP regulatory requirements, industry best practices, and company expectations in resolving audit findings and non-conformances.
- Provide guidance for GLP, GMP and audit to CMO research and manufacturing laboratories.
- Oversee trial quality and ensure compliance with specific clinical plans for all clinical deliverables and identify and mitigate associated risks.
- Maintain oversight of clinical site selection and activation activities. Ensure appropriate tracking throughout including applicable documentation of trial-related information.
- Track and review monitoring visit reports and ensure standards for monitoring and reporting are met; ensure appropriate and timely follow up on open action items.
- Oversee the set-up and maintenance of the trial master file (TMF) (clinical & PV).
- Maintain and review protocol deviation tracking ensuring standards for reporting are met.
- Work collaboratively with the functional Leader to:
- Assess current policies and directives to ensure that they meet and/or exceed GxPs, create new/ revised policies and directives as needed, and to eventually standardize processes for continuous improvement
- Monitor quality and compliance operational leading and lagging performance indicators across the GXP network to resolve issues and to proactively identify emerging trends to ensure continuous improvement and compliance.
- Ensure all clinical trial activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance.
- Coordinate, facilitate and, conduct training for clinical study teams as required. Address ongoing training needs throughout the study and ensure all trial-specific training is documented appropriately.
- Proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.
- Lead through influence and working in cross functional / matrix teams to investigate and manage quality and compliance related issues.
- At the discretion of the Vice President, Global Regulatory Affairs and Compliance, work with functional Quality teams to assist in the preparation and management of global regulatory inspections. Assist in the generation of holistic written responses to regulatory inspectional observations and/or health authority reports, as requested.
- Working with VP, Global Regulatory Affairs and Compliance and across the GxP functional network, generate new approaches to advance a Compliance Excellence mindset. Inspire transformative thinking and motivate employees to deliver transformative performance.
- Keep up with updated regulatory landscape and lead in the sharing of best practices and lessons learned to embrace evolving regulations/expectations.
- Degree in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Master or advanced degree is preferred.
- Minimum of 10 years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.
- Cell therapy experience is highly desirable.
- In-depth working knowledge of GMP, GCP, GLP and FDA and ICH guidelines.
- Experience interacting with US FDA ORA and CBER preferred.
- Experience leading or supporting clinical trial sites and clinical manufacturing sites through global health authority inspections.
- Ability to identify and implement phase-appropriate compliance strategies to support the E2E product lifecycle.
- Demonstrated ability to apply effective risk management approaches. Pragmatic in approach with demonstrated ability to make sound, risk-based decisions.
- Demonstrated ability to work independently and with groups of people/teams in a start-up environment.
- Approximately 30-40% travel within US and international audit Sites and may also support regulatory inspections of clinical sites and company facilities.
Salary up to $200K + 20% Annual Bonus + LTI
Remotely based at current home location. Travel to Asia clinical sites periodically
No, not at this time.
NC - 5499