Associate Director, IT GxP & Quality Systems

Qualifications:

• Education/Training:
• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, IT, or related field.
• 10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries.
• Experience:
• Significant experience leading GxP and Quality Systems within a pharmaceutical, biotechnology, or other regulated life sciences environment. At least 10 plus in management of digital capabilities.
• Strong hands-on experience with Quality Management Systems; MasterControl experience strongly preferred.
• Experience with GxP platforms supporting Quality, clinical operations, cell and gene therapy, chain of identity/chain of custody, or other regulated business processes; TrakCel or other market chain of identity/chain of custody experience strongly preferred for commercialization.
• Experience with other leading industry platforms such as Veeva is highly desirable.
• Demonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives.
• Experience managing GxP application portfolios, vendors, and implementation partners.
• Experience with enterprise-wide deployment and support of quality management.
• Experience with broader Quality IT portfolio (LabVantage, LIMS).
• Knowledge:
• Deep understanding of pharmaceutical Quality processes, GxP requirements, and the technology supporting regulated business processes.
• Strong knowledge of computerized system validation/assurance (CSV/CSA), data integrity, electronic records, audit trails, and quality risk management.
• Knowledge of cGMP facilities and cGMP requirements.
• Skills:
• Excellent stakeholder, program management, communication, and leadership skills.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through completion and meet deadlines.
• Ability to exercise judgment within defined procedures and practices to determine appropriate action.
• Detail oriented with strong analytical and problem-solving skills.
• Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Expected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11 compliance.
• ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.