> Markdown version of [/jobs/ext/549112-director-senior-director-cmc-validation](https://www.wearedevelopers.com/jobs/ext/549112-director-senior-director-cmc-validation). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director/Senior Director, CMC Validation - **Company:** Albert B. Sabin Vaccine Institute, Inc. (The) - **Location:** United States (Remote available) - **Experience:** Expert - **Salary:** $190,000.0 - $225,000.0 - **Contract:** Permanent contract - **Skills:** C (Programming Language), Microsoft Word, Microsoft Excel, Adobe Acrobat, Analysis of Variance (ANOVA), Microsoft Outlook, C++ (Programming Language), Failure Mode Effects Analysis, Microsoft PowerPoint, Iq/oq/pq - **Published:** June 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=b390d2df28fb73c6 ## About the Role Do you have experience in Vendor relationship management?, Do you have a Bachelor's degree?, * Bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or a related pharmaceutical science required; advanced degree strongly preferred. * Minimum of 12+ years of experience with GMP validation in biologics, vaccines, or gene/cell therapy, with at least 5 years in a leadership role; Senior Director candidates require 14+ years of experience. * Demonstrated track record of building or significantly expanding validation programs, ideally through PPQ/BLA. * Experience managing CMO/CDMO validation activities for late-stage and commercial products, including oversight of external partners in a remote environment. * Deep knowledge of FDA Process Validation Guidance (2011), ICH Q8-Q10, 21 CFR 210/211, and EU Annex 15 requirements. * Experience authoring or contributing to BLA or MAA submissions, specifically process validation and manufacturing sections. * Familiarity with WHO/CEPI vaccine manufacturing standards. * Experience with FDA pre-approval inspections (PAIs) or EMA GMP inspections as validation SME. * Exceptional technical writing skills; able to author clear, inspection-ready validation documents. * Strong influencing and negotiation skills for managing external CMO partners without direct authority. * Proficiency with risk management tools (ICH Q9, FMEA, criticality assessments) and statistical methods for validation (ANOVA, process capability, sampling plans). * Effective communicator with experience presenting to senior leadership, regulatory agencies, and cross-functional teams. * Organized, detail-oriented, and able to manage multiple parallel workstreams across different CMO sites and time zones. * Strong interpersonal and relationship-building skills, with a demonstrated ability to collaborate effectively across teams. * Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat. * Up to 20% travel within the United States and Europe to support validation activities. ## Description The Director/Senior Director, CMC Validation reports to the Vice President, Chemistry, Manufacturing, & Controls (CMC) and is a strategic, hands-on leader responsible for building and implementing a comprehensive validation program for Sabin's vaccines, which are produced at C(D)MOs globally. This individual will build Sabin's validation strategy from the ground up and implement it across the network. Responsibilities include authoring validation policies, procedures, templates, and related documentation; overseeing validation activities at C(D)MOs; and driving the organization to Process Performance Qualification (PPQ) readiness in alignment with FDA, EMA, WHO, and ICH expectations, as applicable. The role is accountable for designing, hiring, and leading a right-sized validation organization. This position will partner closely across CMC and with Program & Portfolio Management, Quality Assurance, C(D)MOs, and other stakeholders to ensure validation requirements are fulfilled in a smart, risk-based manner, ultimately delivering submission-ready data packages. The Director/Senior Director, CMC Validation serves as a validation subject matter expert (SME) with demonstrated experience building and implementing validation programs for late-phase assets. The successful candidate will bring deep expertise in biologics or viral vaccine validation, strong CMO governance experience, and the technical leadership needed to influence internal and external stakeholders in a fast-paced, late-stage environment. This role will also support future funding initiatives and enable technology transfers to alternate manufacturers., * Work across CMC and with Quality Assurance to define Sabin's validation strategy from process characterization through PPQ, ensuring compliance with FDA and ICH guidelines and applicable GMPs (21 CFR Parts 210, 211, 600-610; EU Annex 1, Annex 15; ICH Q10). * Create and support implementation of a risk-based validation program for Sabin, including establishing tools such as FMEA, risk registers, and CPP/CQA/KPP maps to prioritize and justify validation activities in conjunction with Sabin and C(D)MO SMEs. * Design, author, and own Validation Master Plans for Sabin's vaccines, covering upstream, downstream, fill/finish, analytical tests, and shipping activities across the C(D)MOs. * In partnership with SMEs at Sabin and C(D)MOs, define PPQ protocol requirements, including batch selection rationale, acceptance criteria, sampling plans, and statistical approaches for demonstrating process consistency, ensuring that process characterization data packages adequately support PPQ parameter justification. * Work with Portfolio and Program management to map validation activities into existing program timelines and agreed milestones. * Serve as the primary validation interface with C(D)MOs, ensuring validation readiness, providing technical direction, undertaking document review and approval, and deviation support. * Lead risk assessments to proactively identify potential risks and develop mitigation strategies for at-risk validation activities; proactively communicate risks. * Work with other leaders in CMC to establish robust and comprehensive C(D)MO oversight aligned with contract and Quality Agreement obligations. * Prepare relevant validation sections of regulatory filings (BLA, IND, MAA, CTA, etc.) and review submissions, as required. * Partner with Analytical Development SMEs to develop compliant, robust and holistic analytical validation program. * Partner with Quality Assurance to ensure compliant and robust facility and equipment validations (Stage 2A) are performed at manufacturing facilities. * Lead and drive shipping validation activities for Drug Substance, Drug Product, and sample shipments, including completion of route risk assessments, protocol and report authoring, and identification and selection of vendors to perform studies. * Serve as Sabin Validation SME during FDA and EMA inspections and agency meetings, as required. * Experience leading in a matrixed environment; build and lead a high-performing matrixed validation team by partnering and creating strong relationships within Sabin and across external partners. * Championing a culture of quality and continuous improvement, implement lessons learned, and share best practices across the C(D)MO network. ## Related Videos - [Developing the Rich Text Editor for DeepL.com](https://www.wearedevelopers.com/videos/1172-developing-the-rich-text-editor-for-deepl-com) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [AI in Regulated Industry - Validating AI-Enabled Products with PLM and Digital Twins](https://www.wearedevelopers.com/videos/2065-ai-in-regulated-industry-validating-ai-enabled-products-with-plm-and-digital-twins) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Best Companies to Work For in Berlin: Top 14 Companies in 2023 ](https://www.wearedevelopers.com/magazine/188-best-companies-to-work-for-in-berlin-top-14-companies-in-2023) - [How to Write a CV and Interview if You Don't Fully Qualify For The Job](https://www.wearedevelopers.com/magazine/183-how-to-write-a-cv-and-interview-if-you-don-t-fully-qualify-for-the-job) - [Events like RSAC Get You CISOs. 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