Assoc III, Validation

About the role

As a Senior Quality Assurance professional, you will provide strategic leadership for site validation and data integrity programs, ensuring compliance with cGMP requirements and global regulatory expectations. You will serve as a trusted advisor to cross-functional teams, influencing critical quality decisions that support product quality, patient safety, and operational excellence. This role involves shaping validation strategies, strengthening data integrity controls, and driving a culture of quality and accountability across the site. Success is measured by the effectiveness of validation and governance programs, sustained compliance, inspection readiness, and proactive management of quality and compliance risks.

Responsibilities

• Provide Quality Assurance leadership and oversight for complex validation projects, ensuring sound scientific and risk-based decision making throughout the system lifecycle.
• Review and approve validation documentation, including plans, protocols, reports, risk assessments, change controls, and revalidation activities.
• Partner with R&D, Manufacturing, Engineering, and Quality teams to support new product introductions and commercial manufacturing readiness.
• Lead the site's Data Integrity Governance Program, ensuring alignment with GAMP 5, 21 CFR Part 11, ALCOA+ principles, and applicable regulatory requirements.
• Establish and maintain governance processes for computerized systems, including periodic reviews, audit trail requirements, user access management, and remediation effectiveness monitoring.
• Lead investigations and assess the impact of significant validation or data integrity events on product quality, compliance, and validated state.
• Monitor program performance through metrics and trend analysis, calling out risks and recommending improvements to site leadership.
• Support regulatory inspections and audits, present program strategy and evidence to inspectors, and drive continuous improvement through cross-functional collaboration and mentoring.

Requirements

• Bachelor's degree in Engineering, Science, Computer Science, or a related technical field.
• 5+ years of experience in Quality Assurance, validation, computerized systems, data integrity, or a related field within pharmaceutical, biotechnology, or medical device manufacturing.
• Strong knowledge of validation lifecycle management, computerized systems, data integrity principles, risk management, and applicable regulatory requirements.
• Experience reviewing and approving validation documentation and assessing compliance risks within regulated environments.
• Proven ability to lead cross-functional initiatives, influence team members, and communicate effectively with all levels of the organization.
• Strong analytical, technical writing, investigation, and decision-making skills.
• Experience supporting regulatory inspections and audit activities.
• Ability to manage multiple priorities while maintaining a high level of quality and compliance.
• Must meet all applicable site safety and occupational requirements.
• Experience leading site-wide data integrity or computerized system governance programs.
• Direct interaction with regulatory agencies during inspections involving validation, computerized systems, or data integrity.
• ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), or equivalent certification.

Pay

The estimated base salary for this position is $96,000 – $132,000 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with company stock purchase discounts.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts and educational assistance programs.
• Paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.