The Associate Quality Systems Director is responsible for Quality oversight and management of GxP Computer System Validation (CSV) and Instrument System Qualification activities in accordance with industry standards and regulatory guidance. This position will be the single point of contact and represent the Quality department with both internal and external stakeholders. This is a hands-on Quality Assurance oversight role that will be accountable for ensuring that internal computer systems are appropriately validated before release and maintaining this compliant state throughout the life of said systems. This position requires a broad range of knowledge and a deep understanding of various Health Authority rules and regulations as well as international standards and guidelines.
Essential Duties & Responsibilities
As AD of Quality Systems, you will be the Quality leader for the CSV program, ensuring quality and compliance requirements are met in an efficient and effective manner by way of the following:
- Maintain CSV and Computer System Change Control processes
- Apply risk-based methodologies in the oversight of Computer validation and Instrument System qualification efforts
- Provide leadership and guidance to internal personnel on CSV matters and ensure compliance to applicable industry regulations
- Maintain CSV templates
- Conduct GxP evaluations of new Computer and Instrument Systems
- Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities
- Drive the planning and implementation of Data Integrity controls in Computer and Instrument Systems
- Review CSV lifecycle documentation from a Quality perspective and approve as Quality representative
- Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner
- Work with management and staff to identify feasible resolutions to control Computer and Instrument System compliance gaps and opportunities for improvement
- Review and approve System-specific Administration and User SOPs
- Oversee the readiness of the CSV program to ensure Computer and Instrument Systems are compliant and ready for regulatory inspections
- Be the QA CSV Subject Matter Expert (SME) in support of audits and regulatory inspections, able to answer validation and qualification questions asked by regulatory inspectors
- Provide guidance and direction throughout the GxP Computer and Instrument System Change Control process
- Ensure appropriate standards and practices are implemented for the collection, use, transfer, storage, and deletion of personal information in GxP Computer and Instrument Systems
- Perform Quality oversight and approval of periodic user access review
- Ensure CSV lifecycle documentation is completed and filed appropriately
- Conduct periodic reviews of GxP Computer and Instrument Systems
- Maintain and present applicable metrics and key performance indicators
- Bachelor's degree in life sciences or engineering and ten years of related experience; or,
- Master's degree in life sciences or engineering and eight years of related experience; or,
- PhD in life sciences or engineering and five years of related experience, or;
- Equivalent combination of education/training and experience
The successful candidate will have the following skills and experience:
- Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process
- Experience in employing risk-based approaches to CSV
- Experience in qualification of GLP Instrument Systems
- Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems
- Experience in performing validation of cloud-based Computer solutions
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- A strong knowledge of procedures and best practices related to FDA Regulations, 21 CFR Part 11, Computer System Validation, GAMP 5, GxP (GLP, GCP, GMP, and GVP) practices, and other regulations governing drug development and commercialization
- Ability to communicate regulations and requirements to teams
- Demonstrated strong project management skills
- Works in partnership with GxP Stakeholders to ensure decision-making and Quality approaches related to Computer and Instrument Systems are defined
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
- Able to multi-task and work cross-functionally
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the Quality Systems processes
- Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results
- Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people
- Works with various Contract Organizations and team members to ensure all project/program goals are met
- Broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals with measurable impact and outcomes.
- Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.
- Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.
- Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships.
- Ability to influence decision makers and utilizes sound problem-solving skills to recommend options and implement effective solutions.
- Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.