Director, Quality GxP Systems

Position Overview:

The Director, Quality GxP Systems, is responsible for the compliance of Prothena’s GxP Systems, SDLC processes, and GxP IT Change Management. The successful candidate understands the importance of processes, systems, data, and information used across regulated business functions. In this role, you will work collaboratively with IT and System Business Owners on effective, efficient, and compliant system solutions that enable business deliverables and knowledge management according to the strategy established by the Sr. Director, Quality GxP Systems.

Responsibilities:

• Oversee GxP IT system life cycle management, quality, and compliance, including GxP IT processes, the GxP System Inventory, compliance of system maintenance, validation, and change management
• Oversee GxP IT projects, including implementation and configuration changes, coordinating across functional areas and GxP Systems
• Manage GxP IT vendor agreements, performance metrics, and related vendor audits
• Collaborate with Business Owners and IT to ensure system compliance, optimize system use, and information flow across and between systems.
• Ensure GxP IT systems are validated and maintained in a validated state
• Manage and assist Business owners with GxP IT change controls and system use
• Champion Data Integrity for GxP IT Systems, refine and oversee system integrity audits and any resultant corrective actions
• Ensure GxP Systems are inspection-ready and represented in audits and inspections

Requirements:

Education and Experience

• Bachelor’s degree in a scientific discipline required, master’s degree or equivalent experience preferred
• Hands-on, highly cross-functional, works collaboratively and confidently with business stakeholders
• Ten years of combined computer system and Quality Assurance experience
• Strong Project Management experience
• Strong Knowledge of 21 CFR Part 11, EMA Annex 11, and GAMP 5
• Knowledge and experience with SDLC methodologies in the GxP environment
• Proficient in the administration or support of systems such as Veeva Vault, MasterControl, LMS, and EDMS

Competencies and Attributes:

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful

Compensation Overview:

The anticipated annual salary range for this role at the Director job level is $215,000 to $280,000.  This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.  We may ultimately pay more or less than the posted range, and the range may be modified in the future.  The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Benefits, 401(k) and PTO Overview:

• All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums. 
• Prothena pays the full premium for basic life and disability insurance for all employees.  
• Prothena employees are also eligible to enroll in our Company’s 401(k) plan and are always 100% vested in their account balances.  The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.  
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays – which includes a Company-wide shutdown at the winter holidays.