Director of Process Validation

Director of Process Validation provides strategic and technical oversight of validation activities performed by external drug substance and drug product manufacturing and testing partners (injectables and solid oral dosage forms). Ensures CDMOs/CMOs maintain compliant processes, equipment, utilities, cleaning procedures, and computerized systems in accordance with global cGMP. Focus is on governance, review/approval, and lifecycle management of validation deliverables.

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.
- Lead and/or evaluate validation risk assessments (e.g., FMEA, risk ranking) with CDMOs.
- Define validation acceptance criteria and critical parameters aligned with QbD.
- Ensure CDMOs apply scientific rationale, statistical approaches, and data integrity standards.
- Oversee process validation at contract manufacturing sites.
- Ensure CPPs and CQAs remain in a state of control throughout commercial production.
- Support technology transfers and validation readiness.
- Review and approve commissioning/qualification documents (URS, FAT/SAT summaries, IQ/OQ/PQ).
- 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.
- Ensure CDMOs follow GAMP 5 and Annex 11 for systems impacting product quality, batch documentation, or data integrity.
- Review/approve risk assessments, data integrity assessments, and validation reports.
- Review validation deviations, atypical results, and investigations; ensure CAPA effectiveness.
- Evaluate validation impact assessments as part of change control.
- Perform periodic reviews of validation documentation for ongoing cGMP compliance.
- Participate in audits of contract manufacturers, labs, and service providers.
- Prepare validation content for regulatory submissions and inspections.
- Support partners with observations and sustainable remediation.
- Serve as validation SME; support vendor governance, business reviews, and performance monitoring.

Requirements / Qualifications
- Bachelor’s or Master’s degree in chemical or biomedical engineering or related life sciences.
- 10 years in validation within pharmaceuticals, biotech, or advanced therapies.

Skills / Knowledge (Preferred/Required)
- Experience with or inside CDMOs (strongly preferred) and virtual manufacturing/oversight frameworks.
- 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 (e.g., Six Sigma, Lean).
- 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, CPV; ability to evaluate statistical approaches.
- Strong communication/negotiation skills; ability to analyze complex data and summarize risks.
- Highly organized; manage multiple CDMO interfaces.

Travel
- Less than 20%.