[Hiring] Senior QA Computer System Validation Manager @4D Molecular Therapeutics

Role Description

The Sr. QA Computer System Validation Mgr. is responsible for overseeing the validation, compliance and lifecycle management of GxP computer systems projects across GCP, GMP and GLP environments. This includes clinical, quality, laboratory, enterprise and manufacturing systems to ensure systems are compliant with applicable regulations and industry standards (e.g. FDA, 21CFR Part11, EU Annex 11, GAMP 5, applicable ICH Guidelines) and supports business objectives through risk-based, compliant validation strategies.

This role partners cross-functionally with business partners and IT vendors to ensure validated systems remain compliant throughout its lifecycle and provide appropriate Quality oversight of CSV activities of 4DMT’s GxP computer systems.

Qualifications

• Bachelor’s degree in life sciences, computer science, business or related field.
• Minimum 5-7 years of experience within the biopharmaceutical industry, preferable in both large and small company environments.
• Minimum 4 years experience in QA CSV.
• Strong experience supporting computer systems used in clinical trials through all phases of development.
• Extensive experience supporting the validation of clinical systems (e.g. IRT, EDC, eTMF).
• Thorough working knowledge of computer systems validation and computer software assurance.
• Experience with enterprise, quality, lab and clinical systems ensuring compliance with FDA, EMEA, MHRA and other regulatory requirements.
• Expertise in ICH guidelines, 21CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practices.
• Experience supporting regulatory inspections and audits.
• Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance.

Requirements

• Experience working with all levels of management and consulting with key business stakeholders.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent written and verbal communication skills; strong interpersonal skills.
• Travel: As needed, less than 5%.

Physical Requirements and Working Conditions

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Compensation

Base salary compensation range: $126,000 - 145,000. Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Equal Employment Opportunity

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities