Senior Quality Specialist, Technical

Accountabilities:

The Senior Quality Specialist will support technical quality activities and structured document workflows while partnering with internal teams and external vendors. Key responsibilities include:

• Support the review and progression of qualification and validation documents through established review and approval workflows using an electronic Quality Management System.
• Review protocols and reports associated with manufacturing process and analytical test method validation.
• Support change controls related to supplier changes and other technical quality activities.
• Review manufacturing and laboratory investigations, including associated CAPAs and effectiveness checks.
• Support data review for internal and external protocols, reports, and other quality documentation.
• Assist with the review and electronic approval of interim stability reports.
• Cross-check regulatory submission data against approved source records to identify discrepancies and support data integrity.
• Develop and maintain knowledge of product validation requirements, manufacturing processes, and analytical testing methods.
• Contribute to technical quality projects as needed.
• Strengthen technical capabilities through knowledge sharing, training, coaching, and mentoring across cross-functional teams.

Requirements:

The ideal candidate brings strong GMP Quality Assurance experience, technical documentation expertise, and the ability to manage complex priorities with a high level of accuracy. Key qualifications include:

• Bachelor’s degree in life sciences or a related discipline; Chemistry, Biology, Chemical Engineering, or another relevant technical/scientific field is preferred.
• Equivalent combinations of education and applicable professional experience may be considered.
• 5+ years of quality experience within the biotechnology or pharmaceutical industry, with exposure to solid oral drug products and/or biologics.
• 5+ years of experience in GMP Quality Assurance, qualification and validation of manufacturing processes and/or test methods, or other relevant Quality Systems.
• Working knowledge of electronic Quality Management Systems; experience with Veeva QMS is a plus.
• Broad understanding of current Good Manufacturing Practices, including applicable CFR, ICH, international regulations, and industry guidelines.
• Strong technical writing, verbal communication, interpersonal, and organizational skills.
• Excellent problem-solving abilities, attention to detail, and a strong sense of urgency.
• Ability to work independently while effectively managing multiple priorities in an environment with time and resource constraints.
• Strong collaboration skills and the ability to work effectively with cross-functional teams and external partners.
• Willingness and ability to travel approximately 10% domestically and internationally.
• Ability to perform face-to-face work with colleagues and/or work onsite in San Diego; the position is not expected to be 100% remote.

Benefits:

• Target base pay range of $95,000–$124,000.
• Short-term incentive compensation in addition to base salary.
• Long-term incentive compensation through company stock.
• Premium health, financial, work-life, and well-being benefits for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with an employer match.
• Generous paid time off.
• Hybrid work environment with opportunities for onsite collaboration in San Diego.
• Opportunities for ongoing technical development through knowledge sharing, training, coaching, and mentoring.