Senior Quality Specialist, Technical

Jobgether; San Diego (CA); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Stock options

Hybrid work environment

Health & wellness benefits

Onsite collaboration in San Diego

Job summary

Jobgether connects candidates with a partner biotech company in the United States seeking a Senior Quality Specialist, Technical based in the United States. The role supports quality assurance activities across solid oral dose and biologic product programs to ensure regulatory and quality requirements are met.

You will review qualification and validation activities, manage quality workflows, and help maintain data integrity while collaborating with internal teams and external manufacturers.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5+ years of quality experience in biotech/pharma.
• Experience with GMP, CFR/ICH guidelines.
• Strong technical writing and communication.
• Experience with qualification and validation of processes/test methods.

Responsibilities

• Review qualification and validation documents per workflows.
• Assess manufacturing and analytical method validation reports.
• Support change controls and CAPA activities.
• Review investigations and effectiveness checks.
• Ensure data integrity and regulatory readiness.
• Collaborate with cross-functional teams and vendors.
• Travel ~10% domestically/internationally.

Skills

GMP Quality Assurance

Quality documentation

Cross-functional collaboration

Analytical thinking

Regulatory understanding

Education

Bachelor's degree in life sciences or related

Tools

Veeva QMS

eQMS familiarity

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Quality Specialist, Technical based in United States.

This role supports quality assurance activities across solid oral dose and biologic product programs, helping ensure products meet regulatory and quality requirements.

You will contribute to qualification and validation activities spanning manufacturing processes, analytical test methods, and product transfer initiatives.

The position works closely with cross-functional teams and external manufacturing partners to support safe, effective products for clinical and commercial use.

You will review technical documentation, manage quality workflows, assess data, and help maintain strong compliance across the product lifecycle.

The role offers exposure to GMP Quality Systems, electronic QMS platforms, regulatory requirements, investigations, CAPAs, and validation activities.

You will also build technical expertise through collaboration, knowledge sharing, coaching, and mentoring in a fast-paced environment.

This is an opportunity to make a direct contribution to quality and compliance within a science-driven organization focused on rare disease therapies.

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 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice:

By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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