Manager, GMP Quality Operations
About The Position
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%
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.
- 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 escalate quality risks effectively.
Nice To Haves
- Hands-on experience supporting external manufacturing/CDMO operations
- Experience supporting late-stage clinical development and/or commercial manufacturing environments
- Experience with technology transfer, process validation/PPQ, and manufacturing scale-up activities
- 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.
Responsibilities
- 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
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
