Senior Quality Specialist, Technical

Position Summary:

The Senior Specialist, Quality Assurance Technical, will assist the Quality team with qualification/validation documents including product transfer activities supporting solid oral dose and biologic product programs to ensure quality and compliance of product(s) to the Regulatory requirements and applicable guidance. This role works with the cross functional team to ensure safe and effective products are produced by contract vendors for use in ongoing clinical studies and through commercial operations.

• Assist and support the monitoring and progression of technical documents through structured review and approval workflows working with cross functional teams and utilizing the Quality Management System (Veeva}:
  • Protocols and Reports for validation of:
  • Manufacturing Processes
  • Test Methods
  • Change Controls related to supplier changes
  • Manufacturing and Laboratory Investigations
  • Associated CAPA and Effectiveness Checks
• Support data review for internal and external protocols, reports, and other document types where needed.
• Assist with the review and electronic QMS approval of interim stability reports.
• Cross check regulatory submission data against approved source records to identify any discrepancies.
• Develop and maintain knowledge of validation requirements, manufacturing processes and analytical testing applicable to products.
• Maintains and proactively develops technical skill sets while working with cross function team members through knowledge sharing, training, coaching, and mentoring with the goal of professional development and enhanced job performance.
• Support QA with various technical projects as needed.

• Bachelor’s degree in a life science or related field of study. A relevant technical or scientific field, Chemistry, Biology, or Chemical Engineering is preferred. Equivalent combination of education and applicable job experience may be considered.
• 5+ years of experience in quality working with solid oral drug and/or biologics in the biotechnology or pharmaceutical industry.
• 5+ years of experience in GMP Quality Assurance,Qualification/Validation of Process and/or Test Methods or other applicable Quality Systems.
• Knowledge of electronic QMS systems, understanding of Veeva QMS is a plus.
• Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.

• The ideal candidate will embody core values:
  Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Adept problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
• Excellent technical writing, communication, and organizational skills.
• Strong attention to detail and ability to manage multiple priorities.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Comp 95-124K based on level/experience