Director of Process Validation
About The Position
The Director of Process Validation provides strategic and technical oversight of validation activities performed by external drug substance and drug product (injectables and solid oral dosage forms) manufacturing and testing partners. Operating within a virtual pharmaceutical model, this role ensures that all contract development and manufacturing organizations (CDMOs/CMOs) maintain compliant processes, equipment, utilities, cleaning procedures, and computerized systems in accordance with global cGMP requirements. This position focuses on governance, review, approval, and lifecycle management of validation deliverables rather than direct execution. The Director collaborates cross functionally with Quality, Analytical Chemistry, Supply Chain, External Manufacturing, and Regulatory Affairs to support technology transfers, commercial readiness, deviation management, and regulatory inspections.
Requirements
- Bachelor’s or Master’s degree in chemical or biomedical engineering, or other related life sciences discipline.
- 10 years in validation within pharmaceuticals, biotech, or advanced therapies.
- Experience working with or inside CDMOs is strongly preferred.
- Strong understanding of virtual manufacturing models and global CDMO oversight frameworks.
- Demonstrated ability to influence without authority in outsourced environments.
- Experience in aseptic/sterile manufacturing and tableting, of therapeutic peptides, small molecules, biologics, or high potency APIs.
- Knowledge of validation-related processes, Six Sigma, Lean, etc.
- Experience authoring regulatory submissions (e.g., Module 3 validation sections).
- Expertise in ICH Q7/Q8/Q9/Q10, EU Annex 11/15, FDA 21 CFR 210/211.
- Understanding of QbD, risk-based validation, and CPV.
- Capability to evaluate statistical approaches (e.g., process capability, sampling rationale).
- Strong communication and diplomatic negotiation skills with external partners.
- Ability to analyze complex technical data and summarize risks clearly.
- Highly organized, with the ability to manage multiple CDMO interfaces simultaneously.
- Approximate travel: less than 20% of the time
Responsibilities
- Provide technical oversight of process, equipment, utility, shipping and cleaning validation executed by external partners.
- Review and approve validation master plans (VMPs), protocols, reports, and lifecycle documents generated by CDMOs.
- Ensure outsourced activities meet internal standards, ICH guidelines, and global regulatory expectations (FDA, EMA, MHRA, etc.).
- Lead and/or evaluate validation risk assessments (FMEA, risk ranking, etc.) in collaboration with CDMOs.
- Define validation acceptance criteria and critical parameters in alignment with QbD principles.
- Ensure CDMOs apply sound scientific rationale, statistical approaches, and data integrity standards.
- Oversee process validation activities performed at contract manufacturing sites.
- Ensure CPPs and CQAs remain in a state of control throughout commercial production.
- Support technology transfers to new manufacturing or testing sites, ensuring validation readiness.
- Review and approve commissioning/qualification documents (URS, FAT/SAT summaries, IQ/OQ/PQ) produced by CDMOs.
- Assess validation strategies for critical utilities (WFI/PW, HVAC, compressed gases) including sampling plans and qualification data.
- Evaluate cleaning validation strategies, worst-case assessments, and verification data provided by the external site.
- Ensure CDMOs follow GAMP 5 and Annex 11 for systems impacting product quality, batch documentation, or data integrity.
- Review and approve documents including risk assessments, data integrity assessments, and validation reports.
- Review validation deviations, atypical results, and investigations from manufacturing partners; provide technical justification and ensure CAPA effectiveness.
- Evaluate validation impact assessments as part of change control initiated by CDMOs.
- Perform periodic reviews of validation documentation to ensure ongoing cGMP compliance.
- Participate in audits of contract manufacturers, labs, and service providers, as applicable, focused on validation and technical operations.
- Prepare validation related content for regulatory submissions and inspections.
- Help external partners address observations and implement sustainable remediation.
- Serve as the technical operations validation SME in meetings with CDMOs, QA, Supply Chain, and Regulatory.
- Support vendor governance processes, business reviews, and performance monitoring.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
1-10 employees
