Manager, GMP Quality Operations

Socket.dev; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a Manager of GMP Quality Operations to oversee day-to-day quality oversight across external manufacturing and testing networks supporting late-stage clinical and future commercial programs.

The role collaborates with Quality, Regulatory, and CDMOs to ensure cGMP compliance and readiness for inspections. The candidate will manage deviations, investigations, CAPAs, change control, and technology transfer, with experience in batch disposition and regulatory

Qualifications

• Bachelor’s degree required in Life Sciences or related field.
• 7+ years of progressive GMP Quality Operations experience in pharma/biotech.
• Experience supporting external manufacturing/CDMO operations preferred.
• Experience with GMP batch record review, investigations, deviations, CAPA, change control, and product disposition.
• Knowledge of technology transfer, process validation/PPQ, and manufacturing scale-up.
• Experience interfacing with Qualified Persons (QPs) and global product-release functions desirable.
• Strong understanding of FDA/EMA/ICH GMP regulations.

Responsibilities

• Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
• Oversee deviations, OOS/OOT investigations, and CAPAs per cGMP and ICH guidelines.
• Review and approve GMP documentation, including batch records and regulatory submissions support.
• Provide QA support for technology transfer and process validation activities.
• Dispostion GMP batches and interface with QPs and CDMO Quality organizations for product release.
• Manage change controls with stakeholders to ensure proper evaluation of changes.
• Support CDMO quality performance per Quality Agreements and GMP requirements.
• Drive continuous improvement and readiness for inspections.
• Collaborate cross-functionally to support pre-approval inspections and commercial readiness at CDMOs.
• Escalate quality risks and ensure corrective actions as needed.

Skills

GMP knowledge

Quality oversight

CDMO collaboration

Regulatory submission support

Project management

Communication skills

Education

Bachelor’s degree in Life Sciences or related

Job description

Description

The Manager, GMP Quality Operations is responsible for day-to-day Quality oversight of GMP manufacturing and testing activities across Viking’s external manufacturing network, supporting late-stage clinical development and future commercial programs.

The Manager will work closely with Viking Quality, Technical Operations/CMC, Regulatory Affairs, Supply Chain, and external CDMOs to ensure manufacturing, testing, and release activities are executed in compliance with cGMP requirements, Quality Agreements, and Viking quality standards.

This role will provide hands-on Quality Operations support across drug substance, drug product, and combination-product manufacturing activities, including batch record review and disposition, deviation and investigation management, change control, technology transfer, process validation/PPQ, and inspection readiness.

This is an onsite role based in San Diego, CA, with periodic travel to domestic and international CDMOs as required.

Travel: ~25%

Essentials Duties and Responsibilities

The main responsibilities of this role include:

• Manage external Quality Operations activities in support of GMP manufacturing for clinical and future commercial programs.
• Manage deviations, OOS/OOT investigations, and CAPAs in accordance with cGMP requirements and ICH guidelines.
• Review and approve GMP documentation, including batch records, analytical and technical reports, and Quality/CMC documentation supporting regulatory submissions (e.g., IND/IMPD and NDA/MAA).
• Provide QA support for technology transfer and process validation activities.
• Perform disposition of GMP batches and interface with Qualified Persons (QPs) and CDMO Quality organizations to support product release.
• Manage change controls to ensure appropriate evaluation of manufacturing- and testing-related changes by Quality, Regulatory Affairs, and relevant subject matter experts.
• Support management of CDMO quality performance in accordance with Quality Agreements and GMP requirements.
• Drive continuous improvement and inspection readiness activities.
• Collaborate cross-functionally to support pre-approval inspection and commercial readiness activities at CDMOs.
• Participate in compliance discussions and support the resolution of quality issues and implementation of required corrective actions.
• Foster a culture of collaboration, accountability, and operational excellence across internal and external teams.
• Perform additional tasks as assigned

Requirements

Education and Experience Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline.
• 7+ years of progressive experience in GMP Quality Operations within pharmaceutical or biotechnology organizations.

Knowledge and Skills Requirements

• Hands-on experience supporting external manufacturing/CDMO operations strongly preferred.
• Experience supporting late-stage clinical development and/or commercial manufacturing environments preferred.
• Demonstrated experience with GMP batch record review, investigations, deviations, CAPA, change control, and product disposition.
• Experience with technology transfer, process validation/PPQ, and manufacturing scale-up activities preferred.
• Experience with small-molecule drug substance and/or drug product manufacturing.
• Experience with one or more of the following is highly desirable: Sterile injectable manufacturing, including prefilled syringes and vials, Solid oral dosage forms, Drug-device combination products, including autoinjectors
• Experience interfacing with Qualified Persons (QPs) and/or global product-release functions is desirable.
• Working knowledge of applicable global GMP regulations and guidance, including FDA, EMA, and ICH requirements.
• Strong ability to review complex GMP documentation and identify quality, compliance, and product-impact risks.
• Demonstrated ability to work effectively with external CDMOs and cross-functional internal teams without direct authority.
• Strong organizational and project-management skills with the ability to manage multiple priorities and meet aggressive timelines.
• Excellent written and verbal communication skills and the ability to communicate and escalation quality risks effectively.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. #LI-DNI

Salary Description

$110,000.00 - $135,000.00 annual salary