Overview In this role you ensure QA oversight of computer system validation and equipment qualifications, partnering with cross-functional teams to meet regulatory and business needs. You will guide quality activities across SOPs, validation plans, and change controls, supporting audits and inspections. The role focuses on maintaining validated systems and ensuring compliance in a fast-paced environment that supports life-changing therapeutics. You will contribute to continuous improvement in QA processes and help enable scalable, compliant operations.
Compensation / Benefits- Medical Insurance (HDHP with HSA; PPO)
- Dental Insurance
- Vision Insurance
- 401k with Employer Match
- Paid Time Off (4 weeks/yr)
- Paid Holidays (9 + 5 floating)
Responsibilities- Provide QA guidance for computer system and equipment validation activities (e.g., validations, change control)
- QA oversight of computer system validation and equipment qualification programs across multiple systems (e.g., LIMS, ELN, QCBD)
- Review and approve SOPs, policies, and validation/qualification master plans
- Manage QA reviews and approvals of validation documentation and deviation/incidence reports
- Coordinate vendor/consultant qualification for validation activities
- Oversee electronic archives, QC management systems (e.g., ZenQMS, Blue Mountain) and system administration of QM systems
- Monitor periodic reviews of validated systems/equipment and ensure follow-up actions are completed
- Represent QA during regulatory inspections and IT/Business Continuity testing
- Review and approve change controls and Out of Tolerances to ensure timely closure
- Operate with minimal QA engineer management oversight
- Assist with non-core duties as needed
Key requirements- Bachelor's degree in engineering, IT, computer science or related field
- Minimum 5 years of experience in a pharmaceutical/GxP environment
- Hands-on experience with computer system validation and equipment qualification
- Strong knowledge of GxP regulations (FDA, EU, ICH, USP, ISO) and related guidelines (21 CFR Part 11, Annex 11, Annex 15, GAMP)
- Excellent written and verbal communication
- Ability to work in a fast-paced, multi-project environment
- Collaborative and cross-functional teamwork
- GxP regulatory knowledge; 21 CFR Part 11, Annex 11, Annex 15; GAMP guidelines
- Experience with LIMS, ELN, QCBD systems and related validation
- Validation engineering principles and lifecycle management
